The document provides details about Neeraj Ojha's 7-day internship at Aadee Remedies pharmaceutical company. It describes his exposure to various departments including production, quality control, storage, and R&D. In production, he assisted with wet granulation and tablet compression processes. At quality control, he performed various tests on metronidazole and samples. He also learned about the duties of the storage and R&D departments. Overall, the internship provided him valuable practical learning experience about industrial pharmacy operations.
Introduction to Regulatory Affairs - Pauwels Consulting AcademyPauwels Consulting
On Tuesday, June 14, our colleagues Fiorenzo Savoretti, Senior Regulatory and Quality Consultant at Pfizer and Nick Deschacht, Senior RA Consultant at GSK, gave an interesting “Introduction to Regulatory Affairs”.
Fiorenzo and Nick talked about RA and their projects, each from their unique angle. They delivered their presentations for ## attendees at our Brussels office at the Lambroekstraat 5a in Diegem.
Regulatory requirements for drug approval - industrial pharmacy IIJafarali Masi
Regulatory requirements for drug approval - industrial pharmacy IIDrug Development Teams, Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology, General considerations of Investigational New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDA Submissions, Management of Clinical Studies.
Objectives, scope, Organization and structure of retail and wholesale drug store, type and design, dispensing of proprietary products, legal requirements
Production of Soft Gelatin Capsules (Softgel Capsules)Ajjay Kumar Gupta
Production of Soft Gelatin Capsules (Softgel Capsules)
Manufacturing Plant, Detailed Project Report, Profile, Business Plan, Industry Trends, Market Research, Survey, Manufacturing Process, Machinery, Raw Materials, Feasibility Study, Investment Opportunities, Cost and Revenue, Plant Economics, Production Schedule, Working Capital Requirement, Plant Layout, Process Flow Sheet, Cost of Project, Projected Balance Sheets, Profitability Ratios, Break Even Analysis
Soft gelatin (also called softgel or soft elastic) capsules consist of one piece hermetically-sealed soft shells. Soft gelatin capsules are prepared by adding a plasticizer, such as glycerin or polyhydric alcohol (e.g., sorbitol), to gelatin. The plasticizer makes gelatin elastic. Soft gelatin capsules come in various shapes such as spherical, elliptical, oblong, and special tube shapes with and without twist off. They can contain non-aqueous liquids, suspensions, pasty materials, or dry powders.
See more
https://goo.gl/3M1uqj
https://goo.gl/iyeL7i
https://goo.gl/SA1qZF
Contact us:
Niir Project Consultancy Services
106-E, Kamla Nagar, Opp. Spark Mall,
New Delhi-110007, India.
Email: npcs.ei@gmail.com , info@entrepreneurindia.co
Tel: +91-11-23843955, 23845654, 23845886, 8800733955
Mobile: +91-9811043595
Website: www.entrepreneurindia.co , www.niir.org
Tags
Soft Gelatin Capsule Manufacturing, Soft Gelatin Capsule, Softgel Capsules Manufacture, Soft Gelatin Capsules Manufacturing Process, Soft Gelatin Capsules Formulation, Pharmaceutical Capsules Manufacturing, Soft Gelatin Capsules Manufacture, Manufacture of Soft Gelatin Capsules, Softgel Capsule Manufacturing Plant, Softgel Manufacturing, Soft Gelatin Capsule Production, Soft Gelatin Capsule Manufacture, Steps of Softgel Manufacturing, Manufacturing of Soft Gelatin Capsules, How to Make Soft Gelatin Capsules, Process of Manufacturing Soft Gelatin Capsules, Manufacturing Process of Soft Gelatin Capsules, Softgel Manufacturing Formula, Softgel Manufacturing Process, Pharmaceutical Softgel Manufacture, Softgel Manufacturing Line, Capsule Production, Soft Gelatin Capsule Manufacturing in India, Production Process of Soft Gelatin Capsules, Method for Manufacturing Soft Gelatin Capsules, Manufacturing Plant of Soft Gelatin Capsules, Gelatin Capsule Manufacturing Process, Manufacturing Process of Gelatin Capsules, Soft Gelatin Capsules Manufacturing Unit, Production of Soft Gelatin Capsules, Soft Gelatin Capsules Industry, Method for Production of Soft Gelatin Capsules, Process of Manufacturing Softgel, Project Profile on Manufacturing Soft Gelatin Capsules, Production Plant of Soft Gelatin Capsules, Manufacturing Units for Soft Gelatin Capsules, Gelatin Capsule Manufacturing Business, Softgel Capsules Manufacturing Business, Commercial Softgel Production, Soft Gelatin Capsules Manufacturing Business, Softgel Production, Production Planning of Soft Gelatin Capsules
Introduction to Regulatory Affairs - Pauwels Consulting AcademyPauwels Consulting
On Tuesday, June 14, our colleagues Fiorenzo Savoretti, Senior Regulatory and Quality Consultant at Pfizer and Nick Deschacht, Senior RA Consultant at GSK, gave an interesting “Introduction to Regulatory Affairs”.
Fiorenzo and Nick talked about RA and their projects, each from their unique angle. They delivered their presentations for ## attendees at our Brussels office at the Lambroekstraat 5a in Diegem.
Regulatory requirements for drug approval - industrial pharmacy IIJafarali Masi
Regulatory requirements for drug approval - industrial pharmacy IIDrug Development Teams, Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology, General considerations of Investigational New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDA Submissions, Management of Clinical Studies.
Objectives, scope, Organization and structure of retail and wholesale drug store, type and design, dispensing of proprietary products, legal requirements
Production of Soft Gelatin Capsules (Softgel Capsules)Ajjay Kumar Gupta
Production of Soft Gelatin Capsules (Softgel Capsules)
Manufacturing Plant, Detailed Project Report, Profile, Business Plan, Industry Trends, Market Research, Survey, Manufacturing Process, Machinery, Raw Materials, Feasibility Study, Investment Opportunities, Cost and Revenue, Plant Economics, Production Schedule, Working Capital Requirement, Plant Layout, Process Flow Sheet, Cost of Project, Projected Balance Sheets, Profitability Ratios, Break Even Analysis
Soft gelatin (also called softgel or soft elastic) capsules consist of one piece hermetically-sealed soft shells. Soft gelatin capsules are prepared by adding a plasticizer, such as glycerin or polyhydric alcohol (e.g., sorbitol), to gelatin. The plasticizer makes gelatin elastic. Soft gelatin capsules come in various shapes such as spherical, elliptical, oblong, and special tube shapes with and without twist off. They can contain non-aqueous liquids, suspensions, pasty materials, or dry powders.
See more
https://goo.gl/3M1uqj
https://goo.gl/iyeL7i
https://goo.gl/SA1qZF
Contact us:
Niir Project Consultancy Services
106-E, Kamla Nagar, Opp. Spark Mall,
New Delhi-110007, India.
Email: npcs.ei@gmail.com , info@entrepreneurindia.co
Tel: +91-11-23843955, 23845654, 23845886, 8800733955
Mobile: +91-9811043595
Website: www.entrepreneurindia.co , www.niir.org
Tags
Soft Gelatin Capsule Manufacturing, Soft Gelatin Capsule, Softgel Capsules Manufacture, Soft Gelatin Capsules Manufacturing Process, Soft Gelatin Capsules Formulation, Pharmaceutical Capsules Manufacturing, Soft Gelatin Capsules Manufacture, Manufacture of Soft Gelatin Capsules, Softgel Capsule Manufacturing Plant, Softgel Manufacturing, Soft Gelatin Capsule Production, Soft Gelatin Capsule Manufacture, Steps of Softgel Manufacturing, Manufacturing of Soft Gelatin Capsules, How to Make Soft Gelatin Capsules, Process of Manufacturing Soft Gelatin Capsules, Manufacturing Process of Soft Gelatin Capsules, Softgel Manufacturing Formula, Softgel Manufacturing Process, Pharmaceutical Softgel Manufacture, Softgel Manufacturing Line, Capsule Production, Soft Gelatin Capsule Manufacturing in India, Production Process of Soft Gelatin Capsules, Method for Manufacturing Soft Gelatin Capsules, Manufacturing Plant of Soft Gelatin Capsules, Gelatin Capsule Manufacturing Process, Manufacturing Process of Gelatin Capsules, Soft Gelatin Capsules Manufacturing Unit, Production of Soft Gelatin Capsules, Soft Gelatin Capsules Industry, Method for Production of Soft Gelatin Capsules, Process of Manufacturing Softgel, Project Profile on Manufacturing Soft Gelatin Capsules, Production Plant of Soft Gelatin Capsules, Manufacturing Units for Soft Gelatin Capsules, Gelatin Capsule Manufacturing Business, Softgel Capsules Manufacturing Business, Commercial Softgel Production, Soft Gelatin Capsules Manufacturing Business, Softgel Production, Production Planning of Soft Gelatin Capsules
National Pharmaceutical Pricing Authority (NPPA) & Drug Price Control Order (...Dr. Ambekar Abdul Wahid
Introduction to NPPA, The Drug Regulatory System in India, NPPA Activities and Responsibility's, Function and Organization of NPPA, Introduction to DPCO 2013, Salient features of DPCO 2013, Prices of Bulk Drug, Retail price of Formulations, Pricing of Scheduled Formulations, Various Schedules related to DPCO Act and Amendments.
Bioavailability (BA) studies play a major role in the drug development phase for both new drug products and their generic equivalents, and thus attract considerable attention globally. There are several approaches to assess BA and each regulatory authority has its own regulations/guidance for conducting BA studies before approving generic products for marketing in their country. Therefore, a thorough understanding is required of these BA concepts and basic regulatory considerations for conducting BA studies. This article briefly reviews the BA concepts, approaches, designs, and conducting and analysis of data obtained.
INTRODUCTION
• Bioavailability means the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action. For drug products that are not intended to be absorbed into the bloodstream, bioavailability may be assessed by measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action.
• Results in 100% bioavailability as the absorption process is bypassed.
• The absolute bioavailability of a drug, when administered by an extra vascular route is usually less than one (i.e. F<100%).> Oral > Rectal > Topical.
A systematic approach to ensure bioavailability of pharmaceutical products:
BIOAVAILABILITY
It the degree to which, or the rate at which, a medication or other substance is absorbed or becomes available at the targeted place in the body. Bioavailability can be influenced by inactive ingredients (see Excipients) in the drug such as additives that prevent the medication from dissolving in the stomach. If a medication that is intended to be taken on an empty stomach is taken instead with food, this can also change the absorption rate and affect the bioavailability of the active ingredient
BIO AVAILABILITY FRACTION (F):
Bio available fraction it refers to the fraction of administered dose that enters the systemic circulation.
*100
Pilot Plant Scale Up Techniques Used in Pharmaceutical Manufacturing, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgaum/Belagavi
Significance of BA/BE studies in drug research and evaluation of different as...inemet
PharmaCon2007 Congress, Dubrovnik, Croatia "New Technologies and Trends in Pharmacy, Pharmaceutical Industry and Education" http://www.pharmacon2007.com
Abstract is available at http://www.pharmaconnectme.com
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. A presentation compiled from material freely available on the WEB to introduce the concepts of QbD for beginners.
These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
National Pharmaceutical Pricing Authority (NPPA) & Drug Price Control Order (...Dr. Ambekar Abdul Wahid
Introduction to NPPA, The Drug Regulatory System in India, NPPA Activities and Responsibility's, Function and Organization of NPPA, Introduction to DPCO 2013, Salient features of DPCO 2013, Prices of Bulk Drug, Retail price of Formulations, Pricing of Scheduled Formulations, Various Schedules related to DPCO Act and Amendments.
Bioavailability (BA) studies play a major role in the drug development phase for both new drug products and their generic equivalents, and thus attract considerable attention globally. There are several approaches to assess BA and each regulatory authority has its own regulations/guidance for conducting BA studies before approving generic products for marketing in their country. Therefore, a thorough understanding is required of these BA concepts and basic regulatory considerations for conducting BA studies. This article briefly reviews the BA concepts, approaches, designs, and conducting and analysis of data obtained.
INTRODUCTION
• Bioavailability means the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action. For drug products that are not intended to be absorbed into the bloodstream, bioavailability may be assessed by measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action.
• Results in 100% bioavailability as the absorption process is bypassed.
• The absolute bioavailability of a drug, when administered by an extra vascular route is usually less than one (i.e. F<100%).> Oral > Rectal > Topical.
A systematic approach to ensure bioavailability of pharmaceutical products:
BIOAVAILABILITY
It the degree to which, or the rate at which, a medication or other substance is absorbed or becomes available at the targeted place in the body. Bioavailability can be influenced by inactive ingredients (see Excipients) in the drug such as additives that prevent the medication from dissolving in the stomach. If a medication that is intended to be taken on an empty stomach is taken instead with food, this can also change the absorption rate and affect the bioavailability of the active ingredient
BIO AVAILABILITY FRACTION (F):
Bio available fraction it refers to the fraction of administered dose that enters the systemic circulation.
*100
Pilot Plant Scale Up Techniques Used in Pharmaceutical Manufacturing, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgaum/Belagavi
Significance of BA/BE studies in drug research and evaluation of different as...inemet
PharmaCon2007 Congress, Dubrovnik, Croatia "New Technologies and Trends in Pharmacy, Pharmaceutical Industry and Education" http://www.pharmacon2007.com
Abstract is available at http://www.pharmaconnectme.com
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. A presentation compiled from material freely available on the WEB to introduce the concepts of QbD for beginners.
These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
in plant training at arrow pharmaceuticals pvt ltd, ChagunarayanNeerajOjha17
Arrow Pharmaceuticals Pvt. Ltd was established over 7 years ago under the leadership of now technical director Mahesh Bhatta, a veteran in the field of pharmacy education at institutions like Kathmandu University, with a worldwide level of experience in the field of pharmaceutics. Currently there are over 57 shareholders at Arrow Pharmaceuticals including a local Khadka family which owns several businesses and land all over Kathmandu. Due to involvement of locals at different levels of the company, the industry is well taken care of in terms of emergency and security. Over 1 arab rupees has been spent on the facility.
Arrow is a new pharmaceutical company as compared to many old ones in the same line but is picking up the market and good-will at a great pace. Partnership with other pharmaceutical companies is also taking place at a high speed. Madan Thapa is the chief executive at the marketing department in Basundhara, Kathmandu with national and international connections. Current products by Arrow in the market are helping build the industrial goodwill.
The factory location in the Chagunarayan Municipality is very appropriate in many ways. Very close to the tourist hot spot Nagarkot, it might be a prospective spot of student exchange program or foreign pharmaceutical visiting tourism area in many ways. Nearby nurseries and rice paddies provide a very peaceful background for the busy workers of this company and the visitors.
in plant training at arrow pharmaceuticals pvt ltd BhaktapurNeil Ojha
Arrow Pharmaceuticals Pvt. Ltd was established over 7 years ago under the leadership of now technical director Mahesh Bhatta, a veteran in the field of pharmacy education at institutions like Kathmandu University, with a worldwide level of experience in the field of pharmaceutics. Currently there are over 57 shareholders at Arrow Pharmaceuticals including a local Khadka family which owns several businesses and land all over Kathmandu. Due to involvement of locals at different levels of the company, the industry is well taken care of in terms of emergency and security. Over 1 arab rupees has been spent on the facility.
Arrow is a new pharmaceutical company as compared to many old ones in the same line but is picking up the market and good-will at a great pace. Partnership with other pharmaceutical companies is also taking place at a high speed. Madan Thapa is the chief executive at the marketing department in Basundhara, Kathmandu with national and international connections. Current products by Arrow in the market are helping build the industrial goodwill.
The factory location in the Chagunarayan Municipality is very appropriate in many ways. Very close to the tourist hot spot Nagarkot, it might be a prospective spot of student exchange program or foreign pharmaceutical visiting tourism area in many ways. Nearby nurseries and rice paddies provide a very peaceful background for the busy workers of this company and the visitors.
The general objectives of involving the public at different stages in the EIA process were considered by a recent European Commission research project (EC, 1999) as given in the table.
European union is composed of several hundred countries including Muslim nations like Turkey, Albania etc. So, if one gets access into nation like Poland or Romania, he gets access throughout Europe.
Objectives of public participation during stages of the EIA process
Formal opportunities for public participation in EIA are defined in legislation. While rights of involvement in many countries are limited to opportunities for viewing and commenting on finalised reports, in principle, public consultation and participation can occur at every stage in the EIA process. The table summarizes the main objectives of public involvement at each stage of the EIA process, including a detailed description of these objectives (EC, 1999).
In brief, literature shows that there are a number of advantages of involving the public early on in the EIA process. If participation does occur early on then interaction between the public, developer and decision-making body should continue throughout the EIA process if the full benefits are to be seen.
Table : Summary of Objectives of Public Involvement in EIA
Stage of EIA process Objectives of public involvement
Screening
Identification of significant impacts
Scoping
• Identification of public's interest and values
• Identification of priorities for assessment
• Encouraging public understanding of the proposed project
Assessment
• The public can contribute local knowledge and values to the prediction, evaluation and mitigation of impacts
• Improvement in quality and acceptability of EIA report
EIA Report Review
Public contribute to evaluation of quality and acceptability of report
Decision
Public comment on acceptability of project impacts
Monitoring
Public evaluate impacts that occur and support project environmental management process
There is an international agency called Environmental Protection Agency EPA. EPA forms and implements regulations regarding making the environment better.
We are at present in a very critical state as far as the situation of global warming and receding snowcaps in the Antarctica. It has been found that there is a hole in the Ozone layer due to increasing level of pollution throughout the world.
The rising sea-levels are threatening the global community. Moreover, the increasing amount of garbage thrown into the seas is a major problem now for countries like Canada. How to manage this sort of problems is equally challenging in both the developed and underdeveloped nations.
6. Solution mitigation of climate change.pptxNeeraj Ojha
There is an international agency called Environmental Protection Agency EPA. EPA forms and implements regulations regarding making the environment better.
We are at present in a very critical state as far as the situation of global warming and receding snowcaps in the Antarctia. It has been found that there is a hole in the Ozone layer due to increasing level of pollution throughout the world.
5.Climate change and its impact on environment.pptxNeeraj Ojha
There is an international agency called Environmental Protection Agency EPA. EPA forms and implements regulations regarding making the environment better.
We are at present in a very critical state as far as the situation of global warming and receding snowcaps in the Antarctia. It has been found that there is a hole in the Ozone layer due to increasing level of pollution throughout the world.
4BDirect and indirect health effects of climate change.pptxNeeraj Ojha
As far as Nepalese people are concerned, they are very bad in their food habits. Disease like ulcer and diabetes are rampant along Nepalese people. Moreover, there are areas in the country where there is a severe malnutrition.
Factors influencing food habits
•Individual Preferences
Every individual has unique likes and dislikes concerning foods.
•Cultural Influences
A cultural group provides guidelines regarding acceptable foods, food combinations, eating patterns, and eating behaviors.
•Social Influences
Members of asocial group depend on each other, share a common culture, and influence each other's behaviors and values.
As far as Nepalese people are concerned, they are very bad in their food habits. Disease like ulcer and diabetes are rampant along Nepalese people. Moreover, there are areas in the country where there is a severe malnutrition.
Factors influencing food habits
•Individual Preferences
Every individual has unique likes and dislikes concerning foods.
•Cultural Influences
A cultural group provides guidelines regarding acceptable foods, food combinations, eating patterns, and eating behaviors.
•Social Influences
Members of asocial group depend on each other, share a common culture, and influence each other's behaviors and values.
2,3 Greenhouse gases, global scenario, green house effectt and global warming...Neeraj Ojha
As far as Nepalese people are concerned, they are very bad in their food habits. Disease like ulcer and diabetes are rampant along Nepalese people. Moreover, there are areas in the country where there is a severe malnutrition.
Factors influencing food habits
•Individual Preferences
Every individual has unique likes and dislikes concerning foods.
•Cultural Influences
A cultural group provides guidelines regarding acceptable foods, food combinations, eating patterns, and eating behaviors.
•Social Influences
Members of asocial group depend on each other, share a common culture, and influence each other's behaviors and values.
8.1Determinants of Adaptive Capacity.pptxNeeraj Ojha
There is an international agency called Environmental Protection Agency EPA. EPA forms and implements regulations regarding making the environment better.
We are at present in a very critical state as far as the situation of global warming and receding snowcaps in the Antarctia. It has been found that there is a hole in the Ozone layer due to increasing level of pollution throughout the world.
The rising sea-levels are threatening the global community. Moreover, the increasing amount of garbages thrown into the seas is a major problem now for countries like Canada. How to manage this sort of problems is equally challenging in both the developed and underdeveloped nations.
There is an international agency called Environmental Protection Agency EPA. EPA forms and implements regulations regarding making the environment better.
We are at present in a very critical state as far as the situation of global warming and receding snowcaps in the Antarctia. It has been found that there is a hole in the Ozone layer due to increasing level of pollution throughout the world.
The rising sea-levels are threatening the global community. Moreover, the increasing amount of garbages thrown into the seas is a major problem now for countries like Canada. How to manage this sort of problems is equally challenging in both the developed and underdeveloped nations.
4A Socio-economic and environmental impacts of climate change.pptxNeeraj Ojha
As far as Nepalese people are concerned, they are very bad in their food habits. Disease like ulcer and diabetes are rampant along Nepalese people. Moreover, there are areas in the country where there is a severe malnutrition.
Factors influencing food habits
•Individual Preferences
Every individual has unique likes and dislikes concerning foods.
•Cultural Influences
A cultural group provides guidelines regarding acceptable foods, food combinations, eating patterns, and eating behaviors.
•Social Influences
Members of asocial group depend on each other, share a common culture, and influence each other's behaviors and values.
Eating disorders are complex, bio-psycho-social conditions, with multiple causes. Eating disorders arise from a combination of established social, psychological, biological, and interpersonal factors. While they may begin with preoccupations with food and weight, they are most often about much more than food. It is important to understand that the factors that contribute to eating disorders are complex and multifaceted; they are not simply about weight and they are certainly not choices.
अमेरिकामा नेपाली मामिलामा सीबीआईको अनुसन्धान
https://cib.nepalpolice.gov.np/
पछिल्लो समय अमेरिकाको मूलधारको राजनीतिमा नेपाली मूलका थोरै मानिसहरु प्रवेश गर्न सफल भएका छन् । मेरिल्याण्डका प्राध्यापक ह्यारी भण्डारी( Harry Bhandari, Maryland) डेमोक्रेटिक ककसमा प्रवेश गरेका छन् । त्यस्तै दर्शन रौनियार (Darshan Rauniyar, California) अमेरिकी सिनेटमा उम्मेदवार बनेका छन् । उहाँसँग धेरै सहयोग र पैसा भए पनि, एक नाबालिगद्वारा बलात्कारको आरोपमा उहाँलाई ककसमा अवरुद्ध गरियो।
अमेरिकामा प्रचण्ड र कम्युनिस्ट साम्राज्य न्यूयोर्कदेखि टेक्साससम्म फैलिएको छ । उनीहरुले पासाङ लामा, कुन्ती थापा, श्रुति कंसाकार(Euless Texas), सिर्जना मुनिकार(Jerseycity, NJ) , साङ शेर्पा(Construction), विजय पौडेल (Journalism) लगायत अमेरिकामा रहेका आफ्ना एजेन्ट र व्यक्तिसँग चन्दा उठाएर अर्बौं डलरको पैसा लुटेका छन् । श्रीलंकाको तमिल टाइगर्स र भारतीय माओवादीहरू: अष्ट्रेलिया, अमेरिका, युनाइटेड किंगडम र क्यानडा जस्ता विकसित राष्ट्रहरूमा तिनीहरूको धेरै ठूलो सञ्चालन छ।बालकुमारीमा बस्ने माधव नेपालजस्ता मानिसहरूलाई यी कम्युनिष्ट डन र गुण्डाहरूले धेरै रक्षा गर्न सक्छन्। धेरै कांग्रेसका कार्यकर्ताहरू प्रलोभनमा पारेर अमेरिकामा पैसा लुट्दै हत्या वा आत्महत्या जस्तो देखिने गरी हत्या हुन्छ। प्रचण्डको कारबाही क्लिन्टन फाउण्डेशन (Clinton Foundation) , वर्तमान राष्ट्रपति बाइडेन र अमेरिकामा सक्रिय जासुससँग जोडिएको छ ।
चिनियाँहरूले क्वीन्समा 5339 97st कोरोना, NY जस्ता धेरै घरहरू ल्याएका छन् जहाँ उनीहरूले कांग्रेस र राप्रपा कार्यकर्ताहरूलाई प्रलोभनमा पारेका छन् र उनीहरूलाई संयुक्त राज्यको डेमोक्रेटिक पार्टीको सहयोगमा थुनेका छन्। अमेरिकामा धेरै वरिष्ठ राजतन्त्र समर्थक र पूर्व सेना सदस्यहरू(eg. Bishwa Bahadur Shah, Bishal Bikram Shah, Kamala Prasai ) यस तरिकाले मारिएका छन् वा विषाक्त छन्। रञ्जित थापा र बुद्ध बस्ताकोटी जस्ता पूर्वप्रहरी पनि यी अपरेशनमा संलग्न रहेको पाइएको छ ।
यो समग्र परिदृश्यलाई हेर्दा पछिल्लो समयको विकासको सन्दर्भमा नेपालको संविधानमा परिवर्तन र संशोधन गर्नुपर्ने आवश्यकता पनि हामीले देखेका छौं । हामीले लामो समयदेखि अल्पसंख्यक जनसंख्या र गे-लेस्बियन-ट्रान्सजेन्डर (LGBT) समुदायको शक्तिलाई बेवास्ता गर्दै आएका छौं। यही कारणले उनीहरू विदेशी शक्तिसँग गठबन्धन गर्दै राष्ट्रिय सुरक्षाका (national security) लागि खतरा बनिरहेका छन् । विशेषगरी इजरायल जस्ता देशमा सिआइएको कारबाही विश्वका लागि खतरा बन्दै गएको छ । सीआईएको इजरायल राष्ट्रमा ठूलो भूमिगत आणविक सुविधा (underground nuclear weapon facility) छ जुन हाम्रो देशको धेरै नजिक छ। यसको मतलब यो हो कि सानो द्वन्द्वको अवस्थामा सीआईएले(CIA) आफ्नो आणविक शक्ति सिधै नेपालमा घुमाउन सक्छ। तसर्थ, हामी आजदेखि नै होसियार हुनुपर्दछ र अन्य सहयोगीहरूलाई पनि त्यस्तै गर्न चेतावनी दिनु पर्छ।
लिन्डन बी जोनसनले जेएफकेको (JFK) हत्यामा इटालियन माफिया (Organized Crime ) सँग सहयोग गरेको भनिन्छ। माफियाहरूले आफ्नो व्यापार र प्रभाव बढाउन तत्कालीन कम्युनिस्ट भियतनामसँग युद्ध गर्न चाहन्थे। ठ्याक्कै परिस्थिति अहिले हामीले सामना गरिरहेका छौं। अमेरिकाको लुटेरा टोली हाम्रो राष्ट्रसँग युद्ध चाहन्छ र उनीहरूले बाइडेन प्रशासनलाई भारतसँग मिलेर राजधानी काठमाडौंमा आक्रमण गर्न बाध्य पारिरहेका छन् । मोदी सरकारले सधैं नेपाललाई आफ्नो क्षेत्रको रूपमा हावी गर्न खोजेको छ। यसै कारण मनमोहन सिंहको प्रधानमन्त्र
PHG 481 Traditional Systems of Medicine BPHARM syllabus PUNeeraj Ojha
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These Q/A's are based upon the syllabus by Pokhara University based in the city of Pokhara, Nepal. Hope this will be helpful to the beginners in the schools of pharmacy.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
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micro teaching on communication m.sc nursing.pdfAnurag Sharma
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Anti ulcer drugs and their Advance pharmacology ||
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Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
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Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
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Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
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2. Acknowledgement
I am extremelyindebtedtothe technical andnon-technical workersatAadee remedies.Ihadextremely
goodtime learningfromthem byfriendlyconversationsandexchanges. Atproduction,Iamespecially
thankful toSunandanPoudel andSujanKarki whobecame fastfriendsandhelpedme understandalot
aboutthe productiondepartmentinaveryshort time. Itwouldhave beenimpossible tolearnsomuch
insuch a small periodof time.
At QC, fast understandingwithAmitSinghhelpedalottocomprehendthe subtle dutiesof the QC
department. The QCstaffslike SujataDahal,KishorChaudhary, PriyankaBogati andPoudel helpedalot
while performingthe wateranalysisandtestsonMetronidazole.Withoutthe helpof these assistantsat
QC, itwouldhave beenimpossible tocomplete all the tests thatIwasassignedtoina shortdurationof
7 daysat QC.
Besides,I wouldliketoexpressmydeepandsincere gratitudeatSushantPokharel atthe Storage
Departmentalongwiththe non-technical assistantsoverthere.Theyhelpedme understandthe duties
and obligationsatstorage department.Theyshowedme how todosamplinganddispensingatthe
production.SushantPokharel gave me the theoretical understandingof the workthat needstobe done
at the Storage department.
RonashShresthaat QC and SandeshKhatri atR&D alsogave me quickrun at theirrespective
departmentonthe verylastday of internship.Iowe themalot fortheirsupport.
Last but no least,Iwouldlike toexpressmydeepgratitudeandthankstoPrakashBistwho referredme
to thiswonderful organizationandPrashantBasnetwho made mytime atAadee veryeducative andfull
of learningexperiences.
4. CERTIFICAFTION
Thisis to certifyhere thatNeeraj Ojhahassuccessfullycompletedthe in-planttraining/internshipat
Aadee RemediesPvtLimitedthatbeganonPoush4th
2078 and endedonMagh 4th
2078. Duringthis
period, Mr. OjhawasexposedtoProductiondepartment,QualityControl,Store department,Quality
Assurance and R&D.
Duringthisperiod,Mr. Ojha’sconductand behaviorwasfoundtobe extremelybonafide.He seemedto
enjoyworkingandlearningfromthe industrystaff alotthroughoutthis period. We wishhimbestinthe
future.
.........................
PrashantBasnet
Quality/PlantManager
...........................
AmitSingh
QC Officer
.............................
SunandanPoudel
Sr. ProductionOfficer
............................
SujanKarki
Jr. ProductionOfficer
............................
SandeshKhatri
R&D Officer
5. Table of Contents:
CompanyProfile Information
Objective of internship
Abbreviations
•Production
•QualityControl
•Store & Generator
•QA-R&D
•Summaryof processinvolvedinmanufacturingof aparticularproduct
•Water TreatmentPlant
EngineeringandUtility
AirCompressor
Generator
•Conclusion
Suggestion
References
6. 1. CompanyProfile Information:
Aadee remediespvt. Ltd.Isa pharmaceutical companyestablishedin23rd
Ashoj 2060 B.S.and startedits
operationfrom11th
Mangsir2071 B.S. fromImadol,Lalitpurfroman areawhichwas notreally
residentialatthattime.Atthismoment,the companyissurroundedbyseveral residential homes.
Companymostlydealswithdermatological,gynecological,PPIs,dentalandurological products.Santosh
Baral isthe actingmanagingdirectorat the headoffice andPrakashBistat Patan office.Thisindustry
has over40 employeesatthe Imadol locationatthismoment. PlantmanageratAadee isPrashant
Basnetcurrently.He’sbeencontributingtothe pharmaceutical industryforover7 yearsby workingin
pharmaceutical production,GMPrecommendeddocumentationinQA department,handling of
pharmaceutical machinerieslike RMG,FBD,AutomaticCapsule fillingmachine, ointmentmanufacturing
and fillingmachines, ointmentmanufacturingandfillingmachine,Drysyrupfillingline,LiquidfillingLine,
Autocoater,Conventionalcoatingandmuch more. He has expertknowledge onhandlingqualitycontrol
labequipments.Mr.BasnetobservesRegulatoryaffairsandformulationdevelopmentcloselyatAadee.
He alsohas beensupervisingall the technical departmentsintechnical matters.He alsohasbeen
individuallytalkingtoeachpersonnel ineverydepartmenttowardsthe efficientrealizationof
organizational goals.
QA officerslikeRonashShresthaof Sundarijalhave beenpreparingandmaintainingdocumentsright
fromthe stage of procuringraw materials.Theyare alsoinvolvedin processmonitoringateach
department.Ihada lotof opportunitytolearnaboutmedicinal chemistry,qualityassurance,
instrumentation,unitoperations,biotechnology,pharmaceutical management,researchmethodology,
biopharmaceuticsetcfromeachandeveryofficerlevel technical workersatAadee industrywithina
7. veryshort periodof time.These sortof momentespeciallyatQC withAmitSinghwere verymemorable
and informative.
Aadee isone of the fastestgrowingGMP certifiedpharmaceutical companylocatedinKumaripati-19,
Lalitpuralwayslookingforself driven,motivated,disciplinedandcreative teammemberswhetheritbe
as intern,employeesorpartners.
Highlysoldproductsof Aadee include PermethrinLotion5%, Halosol Gel,Halosol-Gointment,HalosolF
ointment, OroHeal Gel,Luly1% cream,Doxclin100 mg tablets,Domirab tabletsetc.
1.1 Objective of internship
General Objective:
To fulfill the internshiprequirementof PokharaUniversityBPharmcourse graduation
SpecificObjective:
To findoutwhichsort of workat industrymightfitformy careerin future;
To practicallyknowwhatI had learnedforover4 yearstheoreticallyatcollege;
To knowand builtalliance withpeoplewhoare engagedinthe careerIam topursue inthe
future;
8. To knowthe work environmentof anindustrial pharmacy;
1.2 Time Frame:
I was at productionhouse fora week.AtQC,I wasactivelyengagedforoveraweek.Iwas scheduledat
Storehouse for3 days.Restof the time,Iwas at QA andR/D.
2 Production
Productiondepartmentinthe industrial pharmacyreferstothe manufacturingareawhere the mass
manufacturingof the productis done asper the methoddevelopedandtestedbyR&Dinassociation
withthe marketingdepartmentandQC.The marketingdepartmentwhichhasa separate establishment
comesup witha productthat the market isdemandinganddevelopsageneral outline of the product
details.Thatisforwardedtothe R&D departmentatindustry.R&Ddevelopsthe productaccordingly
performedstabilitytestswiththe helpof QCand aftera certainperiodof time registersforthe
manufacturinglicenseatDDA.Thisis done online inthe presentmomentsthrough
http://dams.dda.gov.np/login website.The documentsare submittedbyR&Donline andalsoinpaper
printform inperson.Afterapproval byDDA,manufacturinglicense isreceivedbythe companyforthe
productafter necessarydocumentsubmission.
R&D ordersnecessarypackagingmaterialsandlabelingfromcompaniesabroadinthe case of Nepal.
Afterall these primarytasksare completed,the mattergoestoproductiondepartmentforthe bulk
production of the firstfewbatchesunderthe directionof R&D officer. Thisprocessis repeatedby
productiondepartmentunderthe directionof productionofficerwiththe same method everytime the
productis neededagaininbulk.
At mytime inproduction,wetgranulationwasperformedforthe Locettabletsunderthe directionof
Sunandan Poudel andassistance of SujanKarki.Ihada chance to personallyassistthe non-technical
workersat productionduringthe granulation.Allthe process wasalsosupervisedbyPrashantBasnetof
QA.Afterthe sample granuleswere testedandpassedbyQC, the tabletcompressionwasperformedin
the same week. Duringthisperiod,the hardnesstest,friabilitytestanddissolutiontestswere
performedonthe sample tabletsmanytimes.The adjustmentswere alsomade onthe tablet
compressionmachine settings. Afterthe sampletabletsmetthe necessaryrequirementslike dissolution
time (lessthan15 minutes),friability(lessthan1) etc.,the tabletcompressionwasperformedinbulk.
On the firstday over80000 tabletswere producedbythe compressionmachine.Onthe nextday,
several lakhsof tabletswere produced. ThisiscalledIPQC,inprocessqualitycontrol.
9. Dispensingandsamplingwere alsobeingdone atproductionwhileIwasthere. Thiswasdone underthe
presence of QCperson,KishorChaudharyof Saptari inthiscase.The samplingof productslike
permethrinanddispensingof productslike menthol were doneinmypresence.Samplingisthe process
of takingoutsmall portionof productsthat are necessarytobe testedatthat period intime byQC.
Storage departmentdetermines whichproductsneedstobe sampledatthat periodintime depending
uponthe several factors. “Swabpass” isa term usedinthiscase. Thisisdone veryfrequently.
Dispensingisthe processof releasingthe productsnecessary forthe bulkproductionaccordingtothe
ordersreceivedbyotherdepartmentslike marketingandR&D.For the purpose of dispensing,the
machinesare firstcalibratedwiththe standards.Aftertheyare foundfitandOK,the necessaryproducts
are dispensedinappropriate containers.The containers andthe ladlesare properlywashedfirstwith
soap andthenwipedwithisopropylalcohol (IPA).
The dispensedproductsare thenkeptinthe quarantine section.Dispensingmachine isusedwhich
exchangingitemsbetweenstorage andthe production.Thismachine operateswith UV radiationthat
killsthe harmful bacteriainthe containersandpackagingif exposedforatleast30 secsunderUV.
RoomPressure difference ismaintainedverywell inthe productiondepartment.Everypersonis
requiredtowearapronand cap before enteringthe production.Differentslippersare assignedfor
productionareaand maskis necessary.
Tabletsare compressedsolidsubstanceseitherroundorcylindrical inshape containingcertain active
alongwithseveral excipientsmeanttocure certaindisease ormitigate certainmedical condition.
Creamsare semisoliddosage formscontainingdispersible anddispersionsystems.Theycontainmore
than 20% water or volatile componentsandtypically lessthan50% hydrocarbonor waxes.
Ointmentsare alsosemisoliddosageformsmeantespeciallyforapplicationonthe skin.Theycontainan
active substance meanttoact ona skinfora special purpose.Theyhave oilyorgreasyconsistencyand
appearstiff uponapplication.
Granulationisa processof convertingraw material particle intomore spherical anduniformstructure
that can be easilycompressedintotablets.Granulationisgenerallyof twotypes.WetandDry
granulations. Wettingagentorliquidisusedinwetgranulationwhile drygranulationisperformed
withoutanyliquid.
Wet granulationinvolvesthe size reductionof the particlesusingdifferentkindsof mills,sieving,
shifting,mixingetc.
12. Excipientsindifferentcontainerswere weighedanddispensedinadust extractionhood.Thenthe
materialsare sentto a cubicfeetblender.
1. Pre-mixing:
Blenderisusedforthe pre-mixingpurpose.Then,itisdischargedintothe binsformilling.
2. Milling:
Millingismeantforsize reduction. There are several methodsthatcanbe appliedforthe size reduction
process.Material istransferredfromPKBlendertoa QuadroComil formilling.Itisusedtofeedother
excipientsand Pre-Mix.Then,the productisdischargedintothe drums.
3. Blending:
Blendingisdone withthe lubricant.Thisisthe laststepatthe granulationroombefore the beginningof
tabletcompressionatthe differentchamber.
4. TabletCompression:
Tabletcompressiontakesplace inaverycontainedenvironment.Itisa separate chamberat Aadee
Productiondepartmentawayfromthe granulationroom. The blendedproductisdispensedusingdrums
and isfedthroughthe hoppersat the top everyfew minutes.Followingcompression,tabletspass
throughthe dedusteranda metal detector. Rejectedtabletsare passedintothe reconcilatorforthe
disposal.Acceptable tabletsare collectedusingdrumsorhuge plasticbags.
Fewtabletsare testedinthe testingroomforfriability,weightvariation,hardnessetcbeforethe bulk
productionisbegun.
2.2 Process equipmentinclude the following:
1. QuadroComil:
It consistsof mill body,infeedchute,rotorshaft assemblywithimpellerandscreen.All the partsare
constructedof 316 stainless steel.Thisisahighqualityrustresistantsteel.
2. Blender:
All the productcontact surfacesare constructedof 316L stainlesssteel.All othercomponentsare
constructed of 304L stainlesssteel.A timercanvarythe blendingsequence time from0to 20 mins.
3. TabletPress:
The stationhas certaincapacity.It can prove over1 lakhtabletsinnotime.The pressis fullyautomated
withPCIPLCcontrol,recipe anddata loggingsystem.Powderisfedfromthe top.The tabletpresshas
upperand lowercamtracks, upperand lowerpunches,dyes, hydraulicpressforce control systemetc.
Thoroughmixingisdone firstsothat active isuniformlydistributedthroughoutthe mixture. Thisisthen
sievedthroughmeshesof differentsizes.Active iscarefullyhandledduringthisprocessthatnoloss
13. occurs. It isthengranulatedinthe planetarymixer.A tappinghammerisusedtopreventthe granules
fromremainingattachedtothe mixer. A solutionisprepared.Wettingisdone withthishelpof this
solution.Granulesare thendriedinadryerat over40 degree Celsiusof temperature.Glidantsand
lubricantsare thenaddedto the mixer.Final mixingisdone withthe helpof turbulamixer. The sampleis
giventothe QC for confirmation.If itisapproved,compressionisdone ata differentsectionwiththe
helpof tabletcompressor.Necessarytestsare performedatthissectionbeforebulkproductis
underway.
2.3 Tabletcoatingwasperformedthe verynextweekbutIwasshiftedforQCthen.
1. TabletCoating:
Tabletcoatingisa processof coveringupor designingof the outercoveringof the compressed
tabletsoas to increase itsappeal ormake itfeasible forthe consumer.Mostof the time,tablet
coatingmay be sugar coated,entericcoated,filmcoateddependinguponthe needorasper the
timing.
Sugar coatingisdone in orderfor the tablettobe appealingintermsof taste.Mostof the time,
childrendonotwant to consume tabletsdespite the necessity.However,whenthe same tablet
isdesignedwithsugarcoating,itappealstothemas doescandy.
Entericcoatingis done tomake the drughabitable tothe intestinal environment.The stomach
ph isacidicwhile the intestine phisalkaline.Entericcoatingisdone sothat drug issoluble inthe
alkaline environment.Entericcoatedtabletsshouldremainintactinthe gastricenvironmentat
leastfora couple of hours.
Filmcoatingisdone for the protectionfromexternal environmentorthe targeteddrugrelease
process.Thus,tabletcoatinghasvariousfunctionsdependinguponthe needof the moment.
Filmcoatingisdone to hide bitterness,make itsmoothsothatit can be easilyswallowedeg.
Paracetamol. Besidesthe one mentionedhere,there are variousothertypesof tabletcoating.
Variousadvancedequipmentslike coatingpansandothermachinesare usedforthe purpose of
tabletcoating.
2. Typesof tabletcoating:
Entericcoating
Gastric coating( Entericcoatingand Gastric coatingare termsveryinterchangeable.Dtof the
entericandgastric coatingtabletsshouldbe assuchthat the tabletwill remaininthe gastric
environmentatleastfor2 hrs. as mentionedearlier.)Thisisassuredinthe labbypreparinga
buffersolutionoutof HCLand examinedwhetherthe tabletswilldisintegrate inthe periodof
time.
Filmcoating
Sugar coating
Compressioncoating
Electrostaticcoating
14. Dipcoating
Vacuumfilmcoating
MAIC, Magneticallyassistedimpactioncoating
Electrostaticdrycoating
Gelatincoating:Althoughgelatincoatingisdone mostlyinthe case of capsules,itissome times
alsoappliedinthe case of tablets.
3. Critical parametersof tabletcoating:
Critical parametersrefertothose parametersthatare setby pharmacopoeiafor the standard
productionof the pharmaceutical products.Inthe case of coatedtablets,the critical parameters
are as follows:
o Spray rate:Spray rate refersto the quantitysprayof the coatingmaterial perunittime.
Dependinguponthe thicknessof coatingsprayrate is adjusted.
o Inletairtemperature:Airtemperaturedeterminesthe qualityof tabletcoating.Inletair
temperature isincreasedordecreasedasperthe necessity.
o Pan speed:Pansare usedforthe purpose of coating of the tablets.Panspeedsare altered
accordingto the necessity.
o Relationbetweencoatingpanandspraygun: Distance betweenthe coatingpanandspraygun
determinesthe qualityof tabletcoating.So,itmustbe properlyadjusted.
4. Problemsintabletcoating:
Blistering:Blisteringisaprocessinwhichthe coatedtabletshowsa particularnature of
sweating.Or,the tabletsburstoutof the blister.Thiscanbe overcome bypropercare during
the coatingprocess.Milddryingis recommendedinthissituation.
Mottling:Thisisa processof the lossof colorof the tablet.Thismaybe due to interactionwith
the air particlesordue to reactive oxygenspecies,ROS.Toovercome this,properpackaging
mightbe done.Thisisa problemdue tothe lack of propercolor mixing.Toovercome this
problem,coloringagentshouldbe made intocolloid.
Chipping:Thisisa processof slightbreakage of the tabletdue tofrictionduringthe packaging
process.Thiscan be overcome byproperlytestingforthe hardness,friability,dissolution,
disintegrationrate etc.andadjustingthe tabletcoatingmachine accordingly.Panshouldbe
filledwithsufficientamountof core tablets.Appropriatebaffle designsshouldbe used.Highfilm
strengthcoatingformulashouldbe used.Correct panspeedshouldbe recommended.Tablet
toolingshouldbe replaced.Propertabletshape shouldbe used.Optimumsprayrate shouldbe
used.Suspensionsolidlevel shouldbe increased.Hardnessof the filmshouldbe increasedby
increasingthe molecularweightof the coatingpolymer.
Cratering:Thisisa processof formationof little craterlike structuresonthe surface of the
tablets.Crateringcanbe overcome bypropermixingof the raw materialsduringthe granulation
process.Sprayrate shouldbe decreased.Optimumdryingconditionshouldbe used.Viscosityof
the coatingsolutionshouldbe increased.
Picking:
Pitting:
15. Blooming:Lowconcentrationorhighmolecularweightplasticizer isrecommendedinthis
situation.
Blusing:Dryingairtemperature shouldbe decreasedinthiscircumstance.The use of HPMC,
Cellulose etcwiththe sorbital shouldbe avoidedinthissituation.
Bridging:
Capping:
Erosion:
Twinning:Tabletshape shouldbe changed.Lesstackycoatingformulasshouldbe used.
Appropriate tabletshape shouldbe used.Panspeedshouldbe increased.Atomizingspeed
shouldbe increased.Sprayrate shouldbe reduced.Optimumdryingconditionsshouldbe used.
Peelingandfrosting:
Orange peel:Milddryingconditionshouldbe used.Viscositysuspensioncoatingshouldbe used.
Atomizingairpressure shouldbe increased.The sprayrate shouldbe decreased.Betterspray
gunsshouldbe used.Viscosityof the coatingsuspensionshouldbe decreased.Gunshouldbe
adjustedtothe beddistance.
Colorvariation:Colorvariationcanalsohappeninthe tabletcoatingprocess.Variationinthe
colorcan be overcome bypropertemperature,propercolorratioetc.
At a time,onlycouple of problemslistedabove appearsatthe productionhouse andtheyare tackled by
one or more methodsas explainedabove.Experiencedproductionmanagerscome upwith
extraordinarysolutionswhereasnovice personnel cannotdo so mostof the time.
Equipmentavailable atProduction:
21. Quarantine jarsand plasticbags
CleanRoomGarments
Each and everydepartmentincludingthe productionhaddifferentapronsforthe workingstaff,visitors
etc. These clotheswere regularlywashed. There werealsodisposablecapsandglovesatthe
production.Footwearsalsoclassifiedtobe usedoutside andinside.Wearingthe same slippersinside
and outside wasnotallowed.ThiswasfullyenforcedbyQA personnel visitingthe production.
On the otherhand,QC had separate thickglovesforuse at the sectioncontainingmuffle furnaceand
differentaprons formicrobiologysection.
AirlocksandChange-roomsincGMPfacility
No table of contents entriesfound.
3. QualityControl
QC isthe departmentwhere the analysisisdone.So,mostof the time,graduateswithatleastBPharm
degree are requiredtoworkat QC. For over7 days at QC, I wascontinuouslybusyinperforminganalysis
assignedtome by QC officerAmitSingh. Firstdaywasspentonperformingthe analysisof the water
qualitysuppliedbythe watersystematthe company. PH of the waterwastestedusingthe pH meter.
Conductivitywasmeasuredwiththe helpof anotherconductometer.Total dissolvedsolute TDSwas
determinedwiththe helpof anotherdevice. Acidityandalkalinityof the waterwascomparedwiththe
helpof litmus papers. Chloridetestwasdone.Afterthat,nitrate testonthe waterwasdone.Twotypes
of solutionswereprepared.Referencesolutionandtestsolution. Inthe referencetube,4.5ml of
distilledwaterwasmixedwith0.5ml of nitrite standardsolution of 2ppm. To thissame testtube,0.4ml
of potassiumchloridewasaddedalongwith0.1ml diphenylamine solutionalongwith5ml conc
sulphuricacid.Sulphuricacid,nitricacid etc. were keptinthe fume hood.Use of these acidswere done
22. withextracare inside the fume hood.The buretteswere thenwashedandplacedinthe washafter
some time.
Thissolutionwascomparedwiththe testsolutioninadifferenttesttube containing5ml of water(hot
solution). Itwaskeptat50 degree Celsiusfor15 minutes. Anyblue colorinthe testsolutionwasnot
more intense thaninreference solution.Thisprovedthe absenceof nitrates.
Afterthat presence of heavymetalsinthe waterwastestedfor.Tothe 100 ml of purifiedwatersample,
0.075 ml of 0.1 Mnitricacid was added.Then,itwasheateduntil the volume wasreducedto20 ml.
Reference solutionwaspreparedwith10ml of leadstandardsolution(1ppm) and 2 ml of reduced
solution.Blanksolutionwaspreparedwith10ml of distilledwaterand2 ml of reducedsolution.Test
solutionwasthenprepared bytaking12 ml of water.2 ml of buffersolutionwasthenaddedalongwith
1.2 ml of thioacetamidereagent.Theywerethenmixedandexaminedafter 2 minutes.Slightbrown
colorwas observedcomparedtothe blanksolution.Blankwasthencomparedwiththe reference
solution.Anybrowncolorinthe testsolutionwasnotmore intense thaninthe reference solution.
Afterthat,waterwas testedforthe oxidizable substance. To10 ml of sample,1 ml of dilute sulphuric
acid wasaddedalongwith0.01 ml of 0.02 M potassiumpermanganate.Itwasthenboiledfor5minutes.
Solutionremainedpink.Colorremained.Thisprovedthe presence of oxidizablesubstances.
Solutionswere preparedasperthe instructionsinthe volume IIof IndianPharmacopoeia.There were
twosectionscalledgeneral reagentsandchemical reagentsinthe volume twoof IPthatwere extremely
useful duringmytime atQC. Some of the codeslike 2.30.04 broughtusback to volume Ifor detailed
informationonthatmatter.I founditeasyto write downonmy notebookall the necessaryinstructions
firston the copy andthencontinue the experiment.
Similar,testswere performedfromthe verynext dayonsample active of Metronidazole(BatchnoMTZ-
0111877). Itwas a white/yellowcrystallinepowder.Samplewassparinglysolubleinwater.Itwas
sparinglysolubleinethanol.Itwasverysoluble inacetone.Itwasverysolubleindichloromethane.In
conclusion,itwasslightlysolubleinbothorganicandinorganicsolvents.
23. Afterthat identification of metronidazole wasdone withthe helpof IR.The powdersample wasplaced
on the FTIR surface and the graph producedmatchedwiththe standardalready presentinthe
computer.Similarly,whenexaminedinthe range 230 nm to 360 nm, a 0.001 % w/vsolutionin0.1 M
hydrochloricacidshowedanabsorptionmaximumatabout 277 nm anda minimumatabout240 nm,
absorbance at about277 nm,between0.365 and 0.395. On the otherhand, identificationwas
performedbyheating10 mg inthe waterbath with10 mg of Znpowder,1 ml of water and 0.25 ml of
2M hydrochloricacidfor 5 minutesandcooled.The solutiongave the reactionof primaryaromatic
amines. Anintense orange colorwasproducedasmentionedinthe pharmacopoeia.
QC officerAmitSinghguidedme withformulasforcreatingsolutionsof particularppm. These easilyset
formulasmade myworkat QC veryeasy.
InstrumentsmostfrequentlyusedatQC include HPLC,FTIR,pH meter,Dissolutionapparatus,
Disintegrationapparatus etc.Apparatusmostlyusedinclude testtube stand,bunsenburner,beakersof
differentsizes,RBflaskof differentsizes,testtubes,litmuspaper,weighingmachine etc.
3.1 Functionsof QC:
QC isone of the most importantdepartmentatthe pharmaceutical industry.QCperformsall the
analysisafterwhicheachdepartmentproceedswiththeirwork.QCperformsthe stabilitytesting upon
the formulationproducedbyR&D.OnlyafterthistestingcanR&D proceedwithobtainingthe necessary
license andregistrationforthe newproduct.QCperformsall the sample testsaccordingtowhichthe
storage departmentclassifiesthe products receivedorbeginsdispensingforthe productionof bulk
quantities.QCpersonisnecessarywhile samplinganddispensing.KishorChaudharydoesthisjobat
Aadee industryanddoesitwell. Moreover,QCperformsall the testsonthe packagingmaterial
accordingto the SOPdevelopedbythe companyandpassesordeniesthe packagingmaterial.So,QC
standsas the most crucial departmentatthe pharmaceutical industry.
24. QC has to performwateranalysisonthe dailybasis.Waterisusedalmosteverywhereinthe
pharmaceutical industryanditisvital thatit fallswithinthe limitdeterminedby the company.
QC alsoperformsthe documentationof eachandeveryanalysisthattake place atthe facility.Mostof
these documentsare preservedforatleast5 yearsand latershreddedordestroyedaccordingtothe
decisionof QA.Recently,documentsweredestroyedbyfire atAadee.Ittooka whole dayforseveral
staffsto helpthemdoso.
QC alsomanagesregularpest/insectcontrol.Mostof these are done on Fridayat the closingtime so
that the effectof insecticideiscompletedonSundaybythe office time.Insectslikecockroachesand
pestslike ratsare strictlypreventedtoenterpharmaceutical facilitiesformanyreasons.
3.2 Raw material analysisisone of the mostimportant functions of QC. Atthismomentintime,raw
materialsare notproducedinNepal.Mostof the activesare receivedfromnationslike IndiaandChina.
In thiscase,the raw material analysisbecomes vitallyimportant.Some of the time productsare sent
that have expirydate earlierthanexpected.Inthiscase,storage departmentregularlysendssamplesto
QC to make sure that the productsare properlyarranged.If QC doesnotapprove certainproduct,
storage departmentcategoriesitaccordinglysothatunapprovedmaterial doesnotgoforproduction.
AmitSinghledme to multipleSOPspreparedbythe companyforthe raw material analysis.Thiswere to
be strictlyfollowedbythe staff's performinganalysis.
25. Microbiologysection:
There wasa separate sectionatQC where the entrance wasstrictlyprohibitedexceptforthe analystin
essential cases.Thiswascalledmicrobiologylab.There wasseparate apronsandglovestoenterinto
thisdepartmenttoavoidcross-contamination.Thiswasthe place where organismcultureswere done.
There waslaminarhood,autoclave,petri-dishesetc.inthissection.
Althoughthere wasnoworkat this spotduringmystay at QC, it has responsibilitiesof performing
microbial tests,antibioticassaysandmicrobial contentof the environment.So,itwassegregatedasa
verysensitiveareaevenwithinthe QC.There wasa refrigeratorandincubatorinthissectionaswell.I
was instructedmanytimesnottoenterthissectionbythe QC officerandanalyststhere.
Besides,instrumentationsectionof the QCcontainedinstrumentslike weighingbalance,potentiometer,
hardnesstester,friabilitytester, potentiometer,disintegrationtestapparatus,tabletdissolution
apparatus,tabletdensitytestapparatus,digitalvernier caliper,flamephotometer,polarimeter,melting
pointtestapparatus,Karl Fischertitrator,UV visible spectrometer,FTIR,HPLCetc.
Chemical analysisroomof the QCcontainedwaterbath,fumeshood,magneticstirrer,sonicator,
separatingfunnel,pHmeter,centrifugemachine, vacuumpump,condenser,oven, muffle furnace,
several chemicalsetc.
Stabilitytestingchamberscontainedreal time andacceleratedstabilitytestingmachines.
5. Store Department
Thiswas where Ilearnedalot aboutabbreviationsusedatthe industrylike TR,RT date,difference
betweenPEG-400and PEG-4000 etc. SushantPokharel ledme tomultipleSOPsthatincluded
instructionsfordispensing,documentation,operationof BugZapperetc.
I was sentto productiondepartmentalongwithnon-technical workersof store forsamplingand
dispensingontwoseparate days.Inthiswas I wasable to observe inpersonthe operationsthatare
conductedduringthese sensitive procedures.
26. Raw materialswere classifiedatthe store as actives,excipientsandliquid/gelsinseparate columns.The
blisterpackagingwasstoredata separate room.The packaging's that requiredrefrigerationwere stored
inthe refrigerator.
Refrigeratedpackingmaterialsatthe store
There isa dispensingbox usingUV radiationconnectingthe dispensingboothof the production
departmentwiththe store department.Atleast30 secondsof exposure toUV in the dispensingbox
disinfectsmostof the microorganismspresentinthe packaging materials.
Dependinguponthe type of rawmaterial,theycome packagedindifferenttypesof jars,plasticbagsor
sacks.Some of the raw materialsmaybe borrowedorboughtfrom the nearestpharmaceutical
companyfor the promptuse in case orderingraw material fromabroad.One such case waspresent
while Iwasthere.FloridlaboratorylocatedinGyaneshworhadconfirmedthattheyhadsuchproducts
that Aadee neededatthat moment.
27. 5.1 Store room/Raw material classification
One whole sectioninthe store roomwasdedicatedtostoringORSraw materialsthatincludedsodium
chloride etc.ORSishighlydemandedinthe summerseasoncalled“JivanJal”inNepali. Thisisone of the
mostpopularproductsfor conditionssucha diarrhea,dehydrationetc.Thisproductisalsopopular
amongchildreninNepal.
Store room non-technical staffswere alsoactivelyinvolvedinhelpingQA officeratthe final packaging
section(secondarystore orfinishedgoodstore) byperformingchecksonthe final products,their
expirationdate,manufacturingdate onprimaryandsecondarypackagingmaterials.Theyalsohelped
count productsineach box to assure that theydonot containless,more ordamagedproducts.
QA officerslikeRonashShresthacame tothe final packagingroomforthispurpose on a dailybasis.
28. QC attachesgreenstickersinthe case of approvedproducts,theyattachredstickersinthe case the test
fails.Inthisway,the labellingwithdifferentcolorstickershelpsstore toquicklypickupthe materials
whenneededorsegregate thematthe store.Thistermsegregationiswidelyusedatthe store.
Differentsortsof drugswere handleddifferentlyatthe store:
a. Storedinthe refrigerator:ActiveslikeMupirocin,Bacitracin Zinc, PolymixinB-Sulphate,
Halobetasol,Butenafine HCLetc. were storedinthe refrigerator.
b. Protectedfromlight:Lightsensitive drugslikerabeprazole,Ilaprazole,Duloxeteine HCL,
Tretinoin,Mometasone, Hydroquinone,FerrousAscorbate,Lornoxicam, Leflunomide etc. were
protectedfromthe light.While samplingordispensing,theywere keptindark-blackcolored or
ambercoloredpolybags.If necessary,theywere packagedinaluminumfoils.
c. Protectfrommoisture:Drugslike rabeprazole sodium, Ilaprazole,Doxycycline,folicacidsetc
were protectedfromthe moisture. Theywere storedinadouble layeredpolybagsinawell
closedcontainer.Often,silicagel poucheswere placedbetweenpolybagsandcontainer.Silicais
a good absorberof moisture.
d. Materialswithpungentodoror eye irritation:Drugslike terbinafine,salicylicacid,miconazole
nitrate,Doxycyline Hyclate,Levocetrizine HCL, Mefenamicacid,Benzoyl peroxide etc.were
handledwithextracare usingpropermasksandsafetygoggles.
e. Volatile materials:VolatilematerialslikeCamphorandmenthol werestoredindouble layered
polybagsintightlyclosedcontainersatroomtemperature.
f. Active liquidswere handledwithpropergowningusingapron,gloves, goggles, andmask.They
were storedat roomtemperature inclosedcontainers.
g. Excipientsolidswere storedinclosedcontainers,storedincool anddryplaces.Theywere
protectedfrommoisture.Proper gowningwere usedduringthisprocess.
h. Moisture sensitivematerialslike carbomer940, carbomer980, HPMC 100, HPMC 15U were
storedindouble layeredpolybagsinwellclosedcontainers.Silicagel packswere placedin
betweenpolybagsandcontainerswhennecessary.
29. i. Materialsprovokingallergicreactionslike Chlorocresol,BHT,BHA were handledafterproper
gowning.Directcontactwitheye andskinwas avoided. If allergicreactionwasseen,
immediatelyfirstaidtreatmentwasperformedafterablutionwithwater.
j. Materialswithpungentodorandeye irritation like sodiumlauryl sulphateandsodium
metabisulfitewere handledwithpropergowning,glovesetc.
k. Excipientliquidswere handledinairtightcontainersatroomtemperature usingproper
gowning.
l. Volatile andinflammable materialslike IPA were handledusingaprons,glovesandmasks.
m. Liquidperfumes werehandledinairtightcontainersprotectingfromthe sunlightatcool place
preventingdirectcontactwitheyesandskin.
6. QualityAssurance Department
In thisway,all the departmentsare highlyinter-related.One cannotdowithoutthe other.So,the better
the relationshipbetweenthe departmentheads/officers,the effective the workwillbe. The internal
phone networks helpmake the communicationbetweendepartmentsquickandeasy.
QA includesQCplusall othersactivitiesconnectedtoit.Thus,QA is the headdepartmentasfar as the
industryisconcerned.Theydeal mostlywithdocumentingall the activitiesthattake place throughout
the companyincludingthe SOPs,checkspayable,recruitmentetc. QA hasa manager(PrashantBasnetat
Aadee) andQA officers(Ronash ShresthaatAadee).QA officersdealwiththe mostof the problemslike
ensuringthe finalizationof the bulkproductionandtake the matterto QA manageronlyif theydoubt
theirdecisionorcannotmake the final decision.
QA alsoexecutesthe final shreddingof mostof the documentsafter5 yearshave passed.QA isactively
engagedinsupervisingateverybulkproductionanddispensingatproductiondepartment. QA isthe
departmentthatensuresthe executionof GMPrulesat eachand everydepartmentbeginningwithQA
itself.Documentation,thatis,dowhatyou write andwrite whatyou dois strictlyenforcedbyQA
throughoutthe industry.Documentationsreceivedfromeachdepartmentare thoroughlyreviewedand
thensentfor processinginproperfile cabinet.
Some of the mostimportantfunctionsof the QA are as follows:
1. Batch release:Afterthe certainbatchisproduced,itis keptseparate fromothersat the final
goodsstore.It isthe dutyof QA officertoperformall the examination of the batchthat isbeing
released.Forthispurpose,QA officeralongwiththe store staffsexamineseachandevery
productfor the labelling,packagingandquantity.Marketretail price,MRP,issetso thatthe
productis not soldinthe marketby anymore at price more thanset bythe company.Any
personor pharmacythat sellsthe productat price higherthanMRP is liable tobe punishedby
lawif reported. Forthispurpose,the QA managerregularlysupervisesthroughoutall
departmentstoensure thatbatchrelease isperfectlydoneatall times.
2. Approval:
Approval of QA is requiredbyeachandeverydepartment.Approvalisthe greenlightfromQA togo
aheadwiththe processwhetheritbe bulkproduction,packagingorbatchrelease.Withoutthe QA
30. approval,none of the departmentsare allowedtotake onany endeavor. Inthisaspect,QA isthe
supreme controlleratthe industrylevel andthe QA manager isthe supreme.
QA directsthe creationof masterformulas.The R&D developedmasterformulaislegal atthe company
level onlyafteritisapprovedbythe QA.Master formulaare the most secretdocumentsatthe industry
level.Itisanintellectualpropertyof the company.Incase itis stolenbythe competition,theywillsteal
all the hard work,expenses,staffs andcostof materialsthatwere investedincreatingthatformulation.
So,QA ensuresthatapprovedmasterformulasare keptsecretandnot divulgedtoanypersonthan
those withofficerlevel authorityatthe company.
3. Self-inspection:
On the otherhand,QA officerperformsall the necessaryentriesintothe DDA portal
http://dams.dda.gov.np/ withthe authorizedIDjustlike R&Dfirstentersall the necessarydocuments
for productregistrationbefore submittingtheminthe paperforminperson.Similarly,QA officers
performall the necessaryself-inspectionthroughoutthe companyandsubmitnecessarydocuments
online beforethe inspection arrivesatthe companyinpersonand demandsnecessarydocumentation.
DDA doesnotrenewthe GMP certificate every twoyearsif the companydoesnotpassthe inspection.
4. Validation:
Aadee Remedieshasamulti-productsfacilityatImadol,Lalitpursite here inNepal.Thismanufacturing
facilityisdesignedasperthe GMP incompliance withDDA,Nepal. ValidationMasterPlanincludesall
the mattersrelatedtomaintainingGMPat the Imadol facility.Thesedocumentsandactivities include
Installation Qualification (IQ),OperationQualification(OQ), Performance Qualification(PQ),and
ComputerSystemValidation(CSV).
Validationisgenerallyof 3 types:
♦ Prospective validation:Itisthe validationthatisdone priortothe production of products.
♦ Retrospective validation:Itisthe validationdone afterthe productionof productsandexecution
of packagingactivities.
♦ Concurrentvalidation:Itreferstothe validationdone duringthe production,duringthe analysis
at QC, duringthe packagingor storingof the materialsatthe store.Concurrentvalidationisvery
vital forthe well beingof the companyona longterm.
Special ValidationPlansare developedbythe companyas andwhenrequiredasplanthe demandsof
the people,place andtime e.g. Cleaningvalidation.
Validationisaprocessthatensuresthe consistencyinthe all the thingsdone atthe company.It ensures
that whenthe same processisrepeatedagainandagain,the consistencyremainsinall activities
whetheritbe same staffsor not. In thismanner,the new staffscan alsofollow the same SOPaftermany
yearsand produce the exactsame result.Thisisthe kindof consistencythat GMP alsodemands. Thisis
a processthroughwhichQA savestime,personnel andmoney.Throughvalidation,the same documents
do nothave to be createdagain,eachnew staff doesnotneedto be trainedfromzeroand the process
or masterformuladoesnothave to be createdagainand again.The same validatedinstructionscanbe
followedbyanypersonnel andproduce the same exactresult.The basicideabehindsystematicand
31. scientificstudyinvalidationisduplication.Duplicationisthe principlethatmostof the modern
franchisesare basedonwhere the same processisrepeatedateachestablishmentproducingexactly
the same resultthussavingtime andmoney.Due to the principle of duplication,the product,personnel,
behaviorandprofitcan be estimatedaccuratelyateach franchise.
Thisis ensuredbyscientificstudytoensure thatsystem, equipmentorprocessmeetsorexceedsthe
expectationsof the design, isproperlybuilt,operatedormaintained,issuitable foritsintended
application,conformsto criteriasetbyGMP, will satisfythe regulatorybodies, andiscapable of
operatingconsistentlyorproduce productsof consistentquality.
In orderto ensure processvalidation,multiple observationsare done andmultiple repetitionof the
processesare done.Three repetitionsare generallystandardrequirementforsuchvalidations. Testing
and monitoringare alsorequiredforextendedperiodof time incontrolledenvironments.Inthisway,
validationsare performedtomake the duplication possible.
All the validationsare documented,signedanddated.Theymustbe endorsedbythe QualityUnitof the
organization inordertoput themintoeffect. Atleastthree approvingsignaturesare requiredforthese
documentstobe circulatedthroughoutthe company.These signaturesincludesignatureof QA
Manager, QC Officer,QA officeretc.
Many guidelinesincludingICHare studiedandfollowed duringvalidationprocess.Manyguidelinesare
examinedandthe mostfeasible one ischosenforthe particularvalidation. Processvalidationinvolves
the validationof all the SOPscreatedforeachdepartmentsothat the same SOP can be repeatedagain
and againproducingthe exactresultwhosoeverthe staff maybe.
Failinginvestigationsare recommendedtoQualityassurance forcorrective actionviaDeviation Report.
Utilityvalidationsare equallyimportant.Primaryutilitiesinvolve compressedairandpurifiedwater.
Secondaryutilitiesinvolve HVACetc.These are vital componentsof the industryastheyare essential to
be in operationona dailybasis.
6.1 Process Validation(PV)
PV is establishingdocumentedevidence,whichprovidesahighdegree of assurance thatprocess to
produce productA will alwaysconsistentlyandexactlyproduce the productA meetingitsproduct
specificationsandqualityparameters.
Analysisof datacollectedfrommonitoringwillestablishthe variabilityof processparametersfor
individualrunsandwill establish whetherornotthe equipmentandprocesscontrol are adequate to
assure ProductA specificationsare met. Finishedproductandinprocesstestdata can be of value in
processvalidation, particularlyinsituationswhere qualityattributesandvariabilitycanbe measured.
There are several risksthatmustbe containedtoperformperfectprocessvalidation.
Validationdocumentsare separatelyindexedandclassifiedinaspecial manner.
HeatingVentilationandAirConditioning(HVAC)/EngineeringandUtility
I was touredoutat HVACsectiononthe verylastday by QA officerRonashShrestha.HVACisa very
importantaspectat the industrial pharmacy.Itensuresthe heatingandairconditioningateach
32. departmentasperthe GMP requirementssothat productsproducedmeetthe standardsintermsof
quality,safety,efficacyandmanagement.
AHU-XXXservedthe BlendingRoom#1. AHU-XXXservedthe QC.Similarly AHUXXXserved tablet
compressionroom#1, #2, #3, corridor,staging, wash,and weighingrooms. Asseeninthe picture,other
servedthe warehouse area.
HVACsystemissetat certaintemperature andrelative humidity.Itissetat least12 air changes per
hour. Air handlingsunitsdigitallyadjustthemselvesaccordingtothe feedbacksreceivedfromthe
sensorsandtransmitters.
Pre-coolingcoil,secondcoolingcoil,aftercoolingcoil are some of the temperature maintainingsystems
presentin the HVAC.The maintainthe programmedsupplyof rightconditionairtoeachdepartment.
Supplyairwill be filteredusingterminal HEPA filter.Returnairandexhaustairfromthe room will be
33. filteredthroughterminal HEPA filter. Additional ambientairwill make upforthe total predeterminedair
volume.
AHU servesall othermanufacturingareaslike tabletcompressionroom#1,#2, #3, corridor,staging,
wash,and weighingrooms. A mainexhaustfanlocatedinthe mainareaof the roof will serve areas
requiringdirectexhaust.
Ronashalsoshowedme the watersupplyupstairsandwaterpurificationsystemdownstairs.The
industrial areawasnotpopulatedsomuchin the past butin the recentyears, it'sbeenpopulatedwith
several houses.
6.2 VALIDATION MASTER PLAN Template
PRODUCT X MANUFACTURING FACILITY
Table of Content Page
I. Introduction
II. Scope
III. Validation
IV. Facility Description
V. Process Description
VI. Utility Systems
VII. Process Equipment
VIII. Control System
IX. Responsibilities
X. Project Schedule
XI. Other GMP Programs
34. XII. Reference Documents
XIII. Terms & Definitions
XIV. Appendices
6.3 Management Review
Approved by Signature Date
VALIDATION MANAGER
FACILITY, UTILITY AND
EQUIPMENT QUALIFICATION
MANAGER
COMPUTER VALIDATION
MANAGER
PRODUCT TRANSFER,
PROCESS AND CLEANING
VALIDATION MANAGER
MANUFACTURING MANAGER
PROJECT MANAGER
PLANT ENGINEER
QUALITY ASSURANCE
MANAGER
35. 6.4 GENERAL VALIDATION SCHEDULE & RESPONSIBILITIES
Programme Responsibili
ty
Week
1 2 3 4 5 6 7 8 9 10
1 Establish
Scope
Plant
manager
2 Consult FDC Plant
manager
3 Establish
validation
master
plan(VMP)
Plant
manager
4 Calibrate
laboratory
instruments
QC
5 Validate
analytical
methods
QC
6 Appoint
external
contractor for
IQ & OQ
Plant
manager
7 Collect
document (on
facility,
utility,
systems etc.)
Engineering
8 Establish IQ
protocol
Engineering
*Concept
*Review &
approval
9 Establish OQ
protocol
Engineering
10 Establish PQ
protocol
Production
*Concept
*Review &
approval
11 Establish
validation
performance
QA
12 Training on
GMP, SOPs
& protocols
QA
13 Preparation of
list of
equipment &
instrument for
calibration
QC &
Production
36. 14 Perform
calibration
QA
Lab.
instruments
QC
Production
equipment
Production
15 Establish
SOP, Change
control
QA
16 Performance
of IQ
Engineering
Facility
Utility
Equipment
17 Revise IQ QA/Engineeri
ng
18 Performance
of OQ
Engineering
*Utility
*Equipment
19 Revise OQ Engineering
20 Performance
of PQ/Process
validation
Production
*Equipment/S
ystem-
placebo
21 Revise
PQ/Process
validation
Production
22 Prepare
validation
report
QA
23 Approval/Cer
tification
QA & plant
manag.
Prepare by:
Date:
Checked by:
Date
Authorized by:
Date
No:
Date:
Supersedes No:
For the testing,certificationandmaintenance of mostof the HVACsystemandotherheavy equipment,
engineers fromthe respectivecompaniesfollow upatthe companyor are soughtout.
37. Each SOP iscreatedaccordingto the companystandardsandis providedtothe new internsornewly
hiredpersonnel fortrainingpurposes.Trainedemployeesare strictlyrequiredto follow the SOPaswell.
Trainingprogrammesare oftenorganizedfornew employees.Trainingsare obligatoryforthe new
employeesbefore theybegintheirtask.There are variousreasonstodoso. Equipmentusedfor
calibrationare tracedback to National Institute of MeteorologyandCalibration.
Calibrationisanotherimportantaspectof QA.CalibrationSOPsare createdforthispurpose.
6.5 QualityRiskManagement
Riskmanagementisaveryimportantaspectat QA. There are variouswaysof assessingrisk atdifferent
departments. Hazardidentificationinnecessarytopreventrisksorprepare forthe upcomingdisaster.
Industryisa verysensitive place where littlecarelessnessmightmeanlossof lifeproperty. Therefore,
risksmustbe identifiedandmanaged.Riskmanagementtoolsinclude failuremode andeffectanalysis,
faulttree analysis,fishbonediagram,CAPA etc.
6.7 Corrective andPreventive Action(CAPA)
Corrective actionsare those actionsperformedafterthe problemarises.Preventive actionis already
predictingthe future problemsandtakingactiontoavoidthembefore the problemarises.Thisisthe
majorduty of QA officeratan industry.Inthe case of preventive action,riskisprimarily identified.
Corrective actionsare reactive affairs thustheyare alwaysinferiortothe preventive actionsthatare
proactivelydone.
Example canbe the case of pestcontrol.Eitherwe can waituntil the rats and mice damage ourproducts
at final goodsstore and call the pestcontrol agency.Or, we can regularly schedulesprayingof
insecticidesandpesticidesonaregularbasis. Thispreventive actionistakenatAadee everyfew weeks.
Thisway the organizationcantake proactive stance ineach and everysituationratherthanwaitforthe
problemtoarise.Preventactionsinlongtermprove tobe cost effective andtime savingthancorrective
actions.
Initiationof CAPA includesalistof activitiesstrictlytobe followedbythe groupof personnel involved.It
includessubmissionof source documentby departmentheadtoQA,makinga decision, assigningthe
source documentnumber,fillingupthe CAPA form, sendingthe CAPA form,forwardingthe form,
assigninganidentificationcode consistingof departmentcode,serial numberandlastdigitof calendar
year.
Similarly,closure andverificationof the CAPA involvesalistof procedurestobe followedstrictly. They
include certifyingthe documentaftercompletionof actions,verifyingthe completionand
implementationwithsupportingdocuments,maintainingthe recordof documents,submittingthe
documentsbyQA personthe managementcommitteeduringregularmeetings,verificationandreview
by the managementandmakingthemavailableuponapproval bythe executivecommittee only.
6.8 ProductRecall and Withdrawal
Productrecall and withdrawal referstothe removingorpullingbackof a batch or all the batchesof a
certainproductdue to company report of qualityof productsor DDA notice whetheritbe throughDDA
examinationorcustomercomplaint.
38. Thisis a veryexpensive andreputationharmingsituationforeachandeverypharmaceutical company.
So,everythingisdone bythe companypriorto launchingproductinthe marketto preventproduct
recall andwithdrawal.Aadee inlast8years doesnothave more than 1 productrecalled.
For thisreason,R&D placesthe productat acceleratedstabilitytestingmachineforatleast3 months
and performsreal time stabilityafterthe productisproducedinbulk. Anyproblemsseeninthese
stabilitytastingsare seriouslytakenandmightevencause companytopull downall the relatedbatches
fromthe market.
Productrecall may be done forvariousreasonslike packagingissues,wronglabel,toxicityreports,
ineffectiveness,tabletbreakageetc.
6.9 Equipmentqualification(EQ)
Qualificationandvalidationare synonymoustermsusedatthe industry. Itallowsthe trainees,technical
and non-technical workersthe executionof installation,operationalandperformance protocols. EQ
allowsproperoperationof all the equipmentandconsistentproductof qualityproducts.
Equipmentqualificationisdone byassemblingthe validationteam, determiningthe intendeduser
requirements,conductingriskassessment, conductinginstallationandoperational qualification,along
withrequalificationreview.
In Asia,the vendorvalidationisusuallydoneonthe material while inEurope,vendorqualificationis
done inproduction.Inthisway,differentregionsmighthave differentaspectinwhichtheyvalidate.
Some of the machinesthat needequipmentqualificationinclude blisterpackagingproducingmachine,
semi-solidproducingmachine,compressionmachineetc.AtAadee,all of these belongtothe production
house.
6.10 ICH guidelines
Althoughall guidelinesare reviewedandstudiedat Aadee,ICHguidelinesare primarilyfollowedbyQA
officers.ICHguidelinesare primarilymade byfew countrieslikeJapan,USA,Germanyetc.These
guidelinesare strictlyfollowedinthesenations.ICHguidelinesstrictlyenforce certainprinciples similar
to GMP meantto maintainquality,safety,effectivenessandmanagement.
R&D(Summaryof the processinvolvedinmanufacturingof aparticularproduct)
Formulationof aproduct as directedbythe marketingdepartmentisdone byR&D bystudyingresearch
articlesandlookingforperfectcombinationinthe differentpharmacopoeias.Afterthis,atthe R&D lab,
the product iscreatedina small quantityandsenttoQC for acceleratedstabilitytesting.Aftersome
time,usually3months,the productis examinedandif found tofulfillthe requirements,the
manufacturinglicenseapplicationatDDA issubmitted.Productlicense isreceivedif the applicationis
approved.
39. Necessarypackagingmaterialswithlabellingeg tubesorblistersare thenorderedfromthe companies
inIndia.Afterthe necessarypackagingarrivesatthe firm, the productdepartmentiscommandedto
start manufacturingproductunderthe watchof R&D chief.The same processisduplicatedforbulk
productioninthe future.
6.11 Water TreatmentPlant
EWT, EffluentwatertreatmentishighlypromotedbyDDA as perthe GMP requirementtopreventthe
industrial waterreachingthe residential areasandharmingthe ecosystem.Thus,wateristreatedinside
the industry territoryandisconvertedbythe plantintonon-toxicwaterbefore leavingthe industrial
area.
40. Water receivedviatankerpassesthroughtheseseriesof systemsandare processedwell tomake it
usable forthe industrial purpose asseeninthe picture. WaterTreatmentPlantruns 24 hoursat Aadee.I
had an opportunitytoviewthe systemalongwiththe tankupstairs.
6.12 Chiller
Chillerisamachine thatmaintainsthe necessaryrefrigerationirrespective of the weatherconditions.
DuringwinterwhenHVAC cannotmaintainthe necessaryconditions,chillerdoesitswork. Vapor
compressionchillersmove the refrigerantaroundthe systembyusingelectricity.Vaporabsorption
chillersmove the refrigerantaroundthe systembyusingheatenergy.
ChillersatAadee workin conjunction withHVACsystem asshowsinthe diagram.
41. 6.13 Air Compressor
It isa device thatconvertsairintopotential energystoredinpressurizedair.Itforcesmore andmore
intostorage tank thuscontributingtoair pressure increment.
Compressorsare similartopumpsas theybothcan compressthe fluidthusincreasingitspressureand
make it flowthroughthe pipe.
6.14 Generator
Generatorisan essence ata nationlike Nepal where the electricitysupplyisnotdurable andload
sheddingisaregularoccurrence.Inthis situation,if we onlydependuponthe electricitysuppliedby
Nepal ElectricityAuthority,Lalitpur,thenthe pharmaceutical industrywill goindisorder.Thus,forthe
constantsupplyof electricityirrespectiveof powerline supplyespeciallyatHVACsystemandwater
treatmentsystem,generatorisof vital importance.
Generatorautomaticallystoresthe electricityandsuppliesittothe circuitwithoutbreakduringthe
poweroutage.
7. Conclusion
My internshipatAadee wasmeanttofulfill the requirementsof PokharaUniversityforgraduation.
However,Ihadan opportunitytolearnalot onhand aboutthe fieldIwasgoingto be involvedinthe
future.Ihad a chance in personto know a lotmore aboutindustrythanthe industrial tourfrom college
to Chitwanbasedpharmaceutical industries.
At QC,I had a chance to performanalysisindividuallythanatcollege wheredue tolimitedresourcesand
a large group itwas not feasibletodoeach processbymyself.Ihadwonderful co-operationfrom staff
at Aadee.Theypouredoutthere knowledge tome more thanI wascapable of grasping.
Overall,Ihada wonderful timeatAadee.
8. Suggestions:
42. I thinkAadee shouldencourageeachandeverypersonnel atitsfacilitytotake CAPA ona regularbasis.
In thisway,the staff will alsofeel asense of ownershipatthe place theyare working.Theymighteven
come up withcorrective andpreventive actionsthatare far superiorthanthose comingfromofficersat
higherpositions.Suggestionsboxesmightbe placedatsome place inside the companywhere suchstaffs
or eventhe visitorscan place theirideas.Administrationmightsave millionsof rupeeswithasingle good
ideacomingfroman individualthatjustpassedbythe company.
I likedhowQCofficerscheduledtasksforeachassistant/analysteverymorningandletthemenjoyspare
time if theyfinishedtheirtaskonhand.If the same processwouldbe duplicatedateachdepartment,
the productivityof the organizationwouldrise greatly.
Similarly,duringmystayat the company,it wasSujata Dahal’sbirthdayandAmitSingh’sfirst
anniversaryatAadee.If there wasa departmentora personassignedtocelebrate eachstaff’simportant
day,theywouldfeel abelongingtothe organizationandworkharderon theirtasks.Thissort of culture
was notseenat Aadee where eachpersonwastreatedlike aperson. Employee'sloyaltycouldbe earned
inthissort of behavior.
9. References:
RemingtonThe Science andPractice of Pharmacy
ICH Guidelines
https://www.pharmaguideline.com/2010/12/qualification-of-systems-and-equipment.html
Granulationstatespicture reference
http://www.pharmatips.in/Articles/Production/Granulation-Particle-Bonding-Mechanism-Process.aspx
CAPA
https://www.pharmaguideline.com/2011/07/corrective-and-preventive-actions-capa.html