Quality control on secondary packaging materialsAnupriyaNR
Presentation on quality control tests for the secondary packaging materials. Includes the materials used for secondary packaging, ideal properties of the secondary packaging material and various test procedures used for the quality control of the packaging materials.
Quality control on secondary packaging materialsAnupriyaNR
Presentation on quality control tests for the secondary packaging materials. Includes the materials used for secondary packaging, ideal properties of the secondary packaging material and various test procedures used for the quality control of the packaging materials.
As per the ordinance of PCI, it is mandatory for the students to undertake industrial training for 4 weaks in a pharmaceutical manufacturing unit. The training helps the students to understand the industrial scale operation and the use of latest equipment and instrument.
The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based sound science and quality risk management.
General Principles of Analytical Method of Validation.pdfTamannaKumari8
Validation is the process of establishing documentary evidence demonstrating that a procedure, process, activity carried out in
testing and then production maintain the desirable level of compliance all stages.
The process of providing the analytical procedure is acceptable or its intended us.(ICH Q
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS ...Pristyn Research Solutions
THESE ARE SOME COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS INTERVIEW
FOR ENROLLMENT CALL US ON - 9028839789
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
FACEBOOK- https://www.facebook.com/pristynsolutions
INSTAGRAM- https://www.instagram.com/pristyn_res...
TWITTER- https://twitter.com/Pristynresearch
SLIDESHARE- https://www.slideshare.net/azherkhan5916
LINKEDIN- https://www.linkedin.com/in/pristyn-research-191072119/
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
CAREER OPPORTUNITIES OF PHARMACY GRADUATES IN THE PHARMACEUTICAL INDUSTRIES.pdfMd. Zakaria Faruki
Pharmacy is a very important profession, which deals with the manufacturing, handing, proper utilization, dispensing, and administration of life saving drugs.
Granularity of Technology Transfer Process, Documentation, Premises and equipment Qualification and Validation. Premises and equipments. Quality control: Analytical Method Transfer. Qualification and Validation
QUALIFICATION & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
As per the ordinance of PCI, it is mandatory for the students to undertake industrial training for 4 weaks in a pharmaceutical manufacturing unit. The training helps the students to understand the industrial scale operation and the use of latest equipment and instrument.
The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based sound science and quality risk management.
General Principles of Analytical Method of Validation.pdfTamannaKumari8
Validation is the process of establishing documentary evidence demonstrating that a procedure, process, activity carried out in
testing and then production maintain the desirable level of compliance all stages.
The process of providing the analytical procedure is acceptable or its intended us.(ICH Q
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS ...Pristyn Research Solutions
THESE ARE SOME COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS INTERVIEW
FOR ENROLLMENT CALL US ON - 9028839789
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
FACEBOOK- https://www.facebook.com/pristynsolutions
INSTAGRAM- https://www.instagram.com/pristyn_res...
TWITTER- https://twitter.com/Pristynresearch
SLIDESHARE- https://www.slideshare.net/azherkhan5916
LINKEDIN- https://www.linkedin.com/in/pristyn-research-191072119/
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
CAREER OPPORTUNITIES OF PHARMACY GRADUATES IN THE PHARMACEUTICAL INDUSTRIES.pdfMd. Zakaria Faruki
Pharmacy is a very important profession, which deals with the manufacturing, handing, proper utilization, dispensing, and administration of life saving drugs.
Granularity of Technology Transfer Process, Documentation, Premises and equipment Qualification and Validation. Premises and equipments. Quality control: Analytical Method Transfer. Qualification and Validation
QUALIFICATION & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
We offer PCD Pharma Franchise all over India at very low investment initially and dealing in all Pharma Products Categories. We are serving as one of the Best Pharma Franchise Company in India.
Uniray Lifesciences is counted as the top manufacturer and supplier of Top Poultry Feed Supplement In India established in the year 2012. Our company offers top-quality products and all are in high demand. We also provide the Best Ayurvedic PCD Franchise Opportunities and are known as the Top Ayurvedic Third Party Manufacturing Company in India.
Visit at
https://www.uniraylifesciences.co.in/top-pollutary-feed-supplement-in-india/
https://www.facebook.com/Uniraylifesciences/
https://www.linkedin.com/in/shweta-setia/
https://in.pinterest.com/UnirayLifesciences/
https://twitter.com/UnirayL
https://www.instagram.com/uniraylifesciencesofficial/
Best innovative pharmaceuticals firm, 2020..SophiaSmeeth
India plays a pivotal role in the global pharmaceuticals Industry by being one of the largest providers of generic drugs globally. Innovation and low costs of manufacturing are some of the clear advantages that India offers in the global space. The Pharma industry has grown exponentially over the last few years. Here we are going to feature the "Best Innovative Pharmaceuticals Firm_ 2020" that playing the best roll in Pharmaceuticals industry.
Uniray Lifesciences is counted as the top manufacturer and supplier of Liquid Animal Feed Supplement Manufacturers established in the year 2012. Our company offers top-quality products and all are in high demand. We also provide the Best Ayurvedic PCD Franchise Opportunities and are known as the Top Ayurvedic Third Party Manufacturing Company in India.
Visit at
https://www.uniraylifesciences.co.in/liquid-animal-feed-supplement-manufacturers/
https://www.facebook.com/Uniraylifesciences/
https://www.linkedin.com/in/shweta-setia/
https://in.pinterest.com/UnirayLifesciences/
https://twitter.com/UnirayL
https://www.instagram.com/uniraylifesciencesofficial/
Uniray Lifesciences is counted as the top manufacturer and supplier of Animal Feed Supplements Manufacturers In Maharashtra established in the year 2012. Our company offers top-quality products and all are in high demand. We also provide the Best Ayurvedic PCD Franchise Opportunities and are known as the Top Ayurvedic Third Party Manufacturing Company in India.
Visit at
https://www.uniraylifesciences.co.in/animal-feed-supplements-manufacturers-in-maharashtra/
https://www.facebook.com/Uniraylifesciences/
https://www.linkedin.com/in/shweta-setia/
https://in.pinterest.com/UnirayLifesciences/
https://twitter.com/UnirayL
https://www.instagram.com/uniraylifesciencesofficial/
This is the report of my first Summer training in BBA at Lupin, Ankleshwar plant. This whole report is prepared by me with the help of information provided by the company. Production, Dispatch, Store-warehouse, Purchase, Financial, HR departments are included in this project.
This project also include a Mini Project on "Job Satisfaction". I complete this project with the help of Random Survey method. I hop this report will help you in your study.
For any kind of query or correction in the project contact me through
email- rajat.gandhi27@gmail.com
facebook- www.facebook.com/rajat.gandhi28
This is a presentation by Dada Robert in a Your Skill Boost masterclass organised by the Excellence Foundation for South Sudan (EFSS) on Saturday, the 25th and Sunday, the 26th of May 2024.
He discussed the concept of quality improvement, emphasizing its applicability to various aspects of life, including personal, project, and program improvements. He defined quality as doing the right thing at the right time in the right way to achieve the best possible results and discussed the concept of the "gap" between what we know and what we do, and how this gap represents the areas we need to improve. He explained the scientific approach to quality improvement, which involves systematic performance analysis, testing and learning, and implementing change ideas. He also highlighted the importance of client focus and a team approach to quality improvement.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
Ethnobotany and Ethnopharmacology:
Ethnobotany in herbal drug evaluation,
Impact of Ethnobotany in traditional medicine,
New development in herbals,
Bio-prospecting tools for drug discovery,
Role of Ethnopharmacology in drug evaluation,
Reverse Pharmacology.
How to Split Bills in the Odoo 17 POS ModuleCeline George
Bills have a main role in point of sale procedure. It will help to track sales, handling payments and giving receipts to customers. Bill splitting also has an important role in POS. For example, If some friends come together for dinner and if they want to divide the bill then it is possible by POS bill splitting. This slide will show how to split bills in odoo 17 POS.
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
The French Revolution Class 9 Study Material pdf free download
industrial training report
1. An
Industrial Tour Report
Submitted to
Dr. A.P.J. Abdul Kalam Technical University, Lucknow
For partial fulfilment
of
Degree of
Bachelor of Pharmacy
By
SHUBHAM SINGH
B. Pharm 8th
semester
Roll no. 1909040500054
Supervised by
DR. ABHAY KUMAR VERMA (Professor)
MRS. ARPITA MISHRA (Associate Professor)
Apex Institute of Pharmacy
Samaspur, Chunar, Mirzapur- 231304
2. Certificate
This is to certify that The Industrial tour report Which is submitted by “SHUBHAM SINGH” in
partial fulfilment of requirement for the degree of “Bachelor of pharmacy” from “Apex Institute
of Pharmacy” affiliated to “Dr. Abdul Kalam Technical University Lucknow” under my
supervision.
This Industrial tour report embodies the work of the candidate ’s himself has been duly completed.
His work is authentic.
Supervisors-
Dr. Abhay Kumar Verma Mrs. Arpita Mishra
Professor Associate Professor
Apex Institute of Pharmacy Apex Institute of Pharmacy
3. Forwarding letter
This is to certify that Mr. SHUBHAM SINGH, Roll no.- 1909040500054 has completed his
Industrial tour report in the supervision of “ Dr. Abhay Kumar Verma and Mrs. Arpita Mishra”
in partial fulfilment of requirement for the degree of bachelor of pharmacy from “Apex Institute
Of Pharmacy” Samaspur, Chunar, Mirzapur affiliated to “Dr. Abdul Kalam Technical
University Lucknow” The Industrial tour report is forwarded to the examiner for the evaluation.
Forwarded by-
Prof. Dr. Sunil Mistry
Principal & Dean
Apex Institute of Pharmacy
4. ACKNOWLEDGMENTS
I wish to acknowledge with a deep sense of heartfelt gratitude and indebtedness to my Industrial
tour report supervisor Dr. Abhay Kumar Verma and Mrs. Arpita Mishra for whom, I got a lot
of inspiration for my task. Their precious guidance can now be expressed only with thanks. I also
would like to express to my deep sense of gratitude to professor Dr. Sunil Mistry (Principal of
AIP) and all the teaching staff of “Apex Institute Of Pharmacy, Samaspur, Chunar,
Mirzapur” Who has been a constant source of inspiration to me. I also offer me humble gratitude
to my friends for their valuable and faithful guidance encouragement and suggestions for the
completion of this industrial tour report expeditiously. I would like to extend my heartfelt thanks
to my parents who provided all needed support required for my industrial tour report.
Thanking you.
SHUBHAM SINGH
B.Pharma 4th
Year
Roll no. 1909040500054
5. Date: 11/03/2023
At Baddi, Himachal Pradesh
INDUSTRIAL VISIT REPORT
Pharmaceutical Industry- 1
Name of Pharmaceutical Industry: NIHAL HEALTH CARE, Plot No.33, EPIP
Phase-1, Jharmajri, Baddi, District- Solan, Himachal Pradesh, India, Pin- 173205
The visit was organised with the prior permission and guidance of Hon. Principal Dr. Sunil
Kumar Mistry, Apex Institute of Pharmacy, Samaspur, Chunar, Mirzapur and Mr. Kulbeer
Singh Arya, Plant Head-HR, NIHAL HEALTH CARE under the supervision of Dr. Abhay
Kumar Verma, Professor and Mrs. Arpita Mishra, Associate professor, Apex Institute of
Pharmacy.
On 11.03.2023 final year students of Apex Institute of Pharmacy, Samaspur, Chunar,
Mirzapur visited one of the top Pharmaceutical industry” NIHAL HEALTH CARE”. This
plant is situated at Plot No.33, EPIP Phase-1, Jharmajri, Baddi, District- Solan,
Himachal Pradesh, India, Pin- 173205. Total 55 students along with 2 faculty members have
joined this Industrial visit. The plant mainly deals with manufacturing and packaging of
6. wide range of Sterile Hypodermic Syringe, Sterile Disposable Needle, Insulin Syringe.
Our college team reached the NIHAL HEALTH CARE at 11:00 am. There we met to eminent
personalities Mr. Kulbeer Singh Arya, Plant Head-HR and Mr. Pawan Sharma, Manager
QA, QC. We had great experience with them. Firstly they brought us to conference room and
welcomed warmly with tea and snacks. They took a brief session about rules and regulations
which had to follow during visit of different sections of NIHAL HEALTH CARE. They
divided our students in 10-10 groups and allowed them to visit. Mr. Pawan Sharma, Manager
QA, QC was briefing to our students regarding manufacturing and packaging of Sterile
Hypodermic Syringes with Needle. Students also gained knowledge of QA and QC department.
Nihal Health Care Established in 2007, at Solan (Himachal Pradesh, India). Nihal Health Care
is a leading name, engaged in manufacturing and supplying a wide range of Sterile Hypodermic
Syringe, Sterile Disposable Needle, Insulin Syringe. The company is founded by Mr. Kapoor
Singh (Owner) who has sharp business acumen and works round the clock to make this firm
renowned in the domain. Managing Director Mr. Gurbhej Singh manage the firm in an efficient
manner to attain maximum clients’ satisfaction. These products are manufactured under the
7. supervision of skilled professionals who have immense expertise as per the defined medical
norms. The offered products are known for their safe usage and sterility.
They have an ISO 9001:2015 & ISO 13485-2016 CE & GMP Certified
Company which ensures to carry out each process of business in an efficient manner. Their
quality experts closely inspect the entire production process, right from the procurement of raw
material to the final delivery of consignment to the clients. Also, they make certain that
production is done according to the standards of Indian medical industry. Further, their
manufacturing unit is fully sterilized that ensure the quality of the products. Furtherpackaging
experts use only medical grade packaging material to pack these products, which ensure safe
transit at the clients’ end. They are backed by a vast distribution network that assists them to
deliver clients’ orders within stipulated time frame at their end.
8.
9.
10. The most common use of a sy inge is to
•
.
Syringe
• A sy inge is a simple pump consisting of a
plunge that figs tig htly in a tube to assist
pushing IiquidS O SOR ids i n‹O an Object eit he
th ough a nee dle, tubing, o a nozzle
administeinjections into thebody
11. Pharmaceutical Industry Visit- 2
Name of Pharmaceutical Industry: Scott- Edil Advance Research Laboratories and
Education Ltd, Hill Top, Industrial area, Bhatoli Kalan, District- Solan, Himachal
Pradesh, India, Pin- 174103
The visit was organised with the prior permission and guidance of Hon. Principal Dr. Sunil
Kumar Mistry, Apex Institute of Pharmacy, Samaspur, Chunar, Mirzapur and Mr. Narender
Soklani, HR, Edil Advance Research Laboratories and Education Ltd under the
supervision of Dr. Abhay Kumar Verma, Professor and Mrs. Arpita Mishra, Associate
professor, Apex Institute of Pharmacy.
On 11.03.2023 at 2:30 pm final year students of Apex Institute of Pharmacy, Samaspur,
Chunar, Mirzapur visited one of the top Pharmaceutical industry Scott- Edil Advance
Research Laboratories and Education Ltd. This plant is situated at Hill Top, Industrial
area, Bhatoli Kalan, District- Solan, Himachal Pradesh, India, Pin- 174103. Total 55
students along with 2 faculty members have joined this Industrial visit. Scott-Edil Advance
Research Laboratories & Education Limited manufactures and distributes generic
12. pharmaceutical products. The Company offers syrups, capsules, ointments, external
preparations, dry powder and liquid injections, oral liquids, and tablets.
Our college team reached the Scott- Edil Advance Research Laboratories and Education
Ltd at 2:30 pm. There we met to eminent personalities Mr. Narendr Soklani, HR and
Manager QC. We had great experience with them. Firstly they brought us to conference room
and welcomed warmly with tea and snacks. They took a brief session about rules and
regulations which had to follow during visit of different sections of Scott- Edil Advance
Research Laboratories and Education Ltd. They divided our students in 10-10 groups and
allow them to visit. Manager QC was briefing to our students regarding manufacturing and
packaging of syrups, capsules, ointments, external preparations, dry powder, liquid injections,
oral liquids, and tablets. Students also gained knowledge of QA and QC department.
13. It is one of the leading pharmaceutical manufacturers in India with a portfolio of over 700 drug
formulations for various therapeutic segments including antibiotics, analgesics,
antihypertensives, anti-diabetics, and vitamin supplements.
This company, WHO-GMP ISO 9001:2008 certified, has three world-class units in Baddi,
Himachal Pradesh, and one in Chandigarh, with manufacturing facilities for injections
(dry/liquid), ophthalmic solutions, oral liquids, dry syrups, tablets, capsules, gels, hand
sanitizer , dietary protein and food supplements under stringent quality-control measures.`
The company owes its success to one man’s far-sightedness—Mr Balram Krishan Aggrawal,
the chairman and the main promoter of Scott-Edil. The modest beginning of the company can
be traced back to the year 1988. It was under Mr Aggarwal’s able leadership that the business
idea born out of a small chemist shop in Kurali flourished into the present-day fourworldclass
manufacturing facilities.
14.
15.
16.
17. CATEGORY OF PRODUCT
We are one of the leading pharmaceutical manufacturers in india with a portfolio of over
700 drugs formulation for various therapeutic segment including
TYPES OF CATEGORY
1. ANTIBIOTICS-
Name of Medicine- Amoxicillin
Cephalosporin
Trimethoprim
Cefixime
Cefuroxime
2. ANALGESIC-
Name of medicine- Voligesic Gel (topical)
Tramaphar
3. ANTIHYPERTENSIVE-
Name of medicine- Amlotis AT 5mg
M Pred 4mg
4. ANTIDIABETICS-
Name of medicine- Dibeform Tab
Affopride M
5. VITAMIN SUPPLEMENTS-
Name of medicine- Multitas QUE
Naturone 200Capsule
18. DEPARTMENT OF INDUSTRY
1. Tablet Section.
* Tablet manufacturing section.
* Tablet coating section.
* Packing & labelling section.
2. Liquid Section.
* Liquid production section.
* Filling & sealing section.
* Packing & labelling section.
4. Quality Control Section.
5. Raw Material Store.
6. Prepared Goods Store.
7. Packaging Department.
TABLET SECTION
TABLET:
Tablets are the solid unit dosage forms containing a medicament or mixture of medicament and
excipients compressed or moulded into solid cylindrical shape having either flat or convex
surface.
Types of Tablets:
➢ Coated tablets
➢ Uncoated tablets
➢ Chewable tablets
➢ Sublimgual tablets
➢ Lozenges
➢ Soluble Tablets
➢ Effervescent tablets
➢ Inserts
Tablet manufacturing Process:
[A] Wet granulation:
19. Introduction
The most widely used process of agglomeration in pharmaceutical industry is wet granulation.
Wet granulation process simply involves wet massing of the powder blend with a granulating
liquid, wet sizing and drying.
Important steps involved in the wet granulation:
i) Mixing of the drug(s) and excipients
ii) Preparation of binder solution
iii) Mixing of binder solution with powder mixture to form wet mass.
iv) Drying of moist granules
v) Mixing of screened granules with disintegrant, glidant, and lubricant.
Advantages
(a) permits mechanical handling of powders without loss of mix quality:
(b) improves the flow of powders by increasing particle size and sphericity:
(c) increases and improves the uniformity of powder density:
(d) improves cohesion during and after compaction:
(e) reduces air entrapment:
(f) reduces the level of dust and cross-contamination:
(g) allows for the addition of a liquid phase to powders (wet process only): and
(h) Makes hydrophobic surfaces hydrophilic.
Limitation of wet granulation:
i) The greatest disadvantage of wet granulation is its cost. It is an expensive process because of
labor, time, equipment, energy and space requirements.
ii) Loss of material during various stages of processing
iii) Stability may be major concern for moisture sensitive or thermo labile drugs
iv) Multiple processing steps add complexity and make validation and control difficult
v) An inherent limitation of wet granulation is that any incompatibility between formulation
components is aggravated.
20. [B] Dry granulation
Introduction
In dry granulation process the powder mixture is compressed without the use of heat and solvent.
It is the least desirable of all methods of granulation. The two basic procedures are to form a
compact of material by compression and then to mill the compact to obtain a granules. Two
methods are used for dry granulation. The more widely used method is slugging, where the
powder is recompressed and the resulting tablet or slug are milled to yield the granules. The
other method is to precompress the powder with pressure rolls using a machine such as
Chilosonator.
Roller compaction
The compaction of powder by means of pressure roll can also be accomplished by a machine
called chilsonator. Unlike tablet machine, the chilsonator turns out a compacted mass in a steady
continuous flow. The powder is fed down between the rollers from the hopper which contains a
spiral auger to feed the powder into the compaction zone. Like slugs, the aggregates are screened
or milled for production into granules.
Use: Use in the production of directly compressible excipients, the compaction of drugs and drug
formulations, the granulation of inorganic materials, the granulation of dry herbal material and
the production of immediate/sustained release formulations.
Processing steps:
Weighing of raw material-screening-mixing-compression to slugs-milling-mixing-compression
to finished tablets
Advantages:
The main advantages of dry granulation or slugging are that it uses less equipments and space. It
eliminates the need for binder solution, heavy mixing equipment and the costly and time
consuming drying step required for wet granulation. Slugging can be used for advantages in the
following situations:
i) For moisture sensitive material
ii) For heat sensitive material
iii) For improved disintegration since powder particles are not bonded together by a binder
21. Disadvantages:
i) It requires a specialized heavy duty tablet press to form slug
ii) It does not permit uniform colour distribution as can be
iii) Achieved with wet granulation where the dye can be incorporated into binder liquid.
iv) The process tends to create more dust than wet granulation, increasing the potential
contamination.
[D] The direct compression process
This method is used when a group of ingredients can be blended and placed in a tablet press to
make a tablet without any of the ingredients having to be changed. This is not very common
because many tablets have active pharmaceutical ingredients which will not allow for direct
compression due to their concentration or the excipients used in formulation are not conducive to
direct compression. Granulation is the process of collecting particles together by creating bonds
between them. There are several different methods of granulation. The most popular, which is
used by over 70% of formulation in tablet manufacture is wet granulation. Dry granulation is
another method used to form granules.
Advantages of Direct Compression:
1. Cost Effectiveness
The prime advantage of direct compression over wet granulation is economic since the direct
compression requires fewer unit operations. This means less equipment, lower power
consumption, less space, less time and less labor leading to reduced production cost of tablets.
2. Stability
Direct compression is more suitable for moisture and heat sensitive APIs, since it eliminates
wetting and drying steps and increases the stability of active ingredients by reducing detrimental
effects. Changes in dissolution profiles are less likely to occur in tablets made by direct
compression on storage than in those made from granulations5. This is extremely important
because the official compendium now requires dissolution specifications in most solid dosage
forms10.
22. 3. Faster Dissolution
Disintegration or dissolution is the rate limiting step in absorption in the case of tablets of poorly
soluble API prepared by wet granulation. The tablets prepared by direct compression disintegrate
into API particles instead of granules that directly come into contact with dissolution fluid and
exhibits comparatively faster dissolution.
4. Less wears & tears of punches
The high compaction pressure involved in the production of tablets by slugging or roller
compaction can be avoided by adopting direct compression. The chances of wear and tear of
punches and dies are less.
5. Simplified Validation
Materials are "in process" for a shorter period of time, resulting in less chance for contamination
or cross contamination, and making it easier to meet the requirement of current good
manufacturing practices. Due to fewer unit operations, the validation and documentation
requirements are reduced. Due to the absence of water in granulation, chance of microbial
growth is minimal in tablets prepared by direct compression.
Limitations of direct compression
1. Segregation
Direct compression is more prone to segregation due to the difference in density of the API and
excipients. The dry state of the material during mixing may induce static charge and lead to
segregation. This may lead to the problems like weight variation and content uniformity.
2. Cost
Directly compressible excipients are the speciality products produced by patented spray drying,
fluid bed drying, roller drying or co-crystallization Hence, the products are relatively costly than
the respective raw materials.
3. Low dilution potential
Most of the directly compressible materials can accommodate only 30-40 % of the poorly
compressible active ingredients like acetaminophen that means the weight of the final tablet to
deliver the 500 mg of acetaminophen would be more than 1300 mg. The large tablets may create
difficulty in swallowing.
23. 4. Re-workability
All the spray-dried directly compressible adjutants show poor rework ability since on preparation
of tablets the original spherical nature of the excipient particles is lost. API that has poor flow
properties and/or low bulk density is difficult to process by direct compression.
5. Lubricant sensitivity
Lubricants have a more adverse effect on the filler, which exhibit almost no fracture or shear on
compression (e.g. starch 1500). The softening effects as well as the hydrophobic effect of
alkaline stearates can be controlled by optimizing the length of blending time to as little as 2-5
min.
6. Variation in functionality
There is a lack of awareness in some situations that the excipient behave differently, depending
upon the vendor so much so that substitution from one source to that of another is not possible.
Hence, there is a need for greater quality control in purchasing of raw material to assure batch
uniformity.
26. LIQUID SECTION
Pharmaceutical syrups are produced by mixing purified water, sweeteners, active
ingredients (API), aromas, flavours and other ingredients (thickeners, etc.). The
ingredients are added by means of metering or dosing systems like flow meters and load cell
s to one or more reactors, the order and quantity of the ingredients to add is
specified in the recipe. Usually, preparations are heated before finishing the addition
of components. Solid products are added by means of solid-liquid blenders or
vacuum systems. When the process is finished, the end product is filtered (if required) and
sent to a storage tank. The product is transferred from the storage tanks to the filling machines by
pumps.
Various Equipments for Syrup Section:--
1. Washing :--- Bottle washer (2000bottle/hr.)
1. (Adsoum pharma eng., Vailsad.)
27. ii. Vaccum bottle cleaning machine.(3600containers/hr.)
1. (Harikrishna engineering,Ahmedabad.)
2. Liquid Production:-- Steam jacketted(400lit.)
i. (Gravson engineers,Mumbai.)
3. Filling & Sealing :-- Automatic filling & sealing machine. (200bottles/min.)
(Ambica pharmaceutical, Mumbai.)
4. Capping:- Bottle capper (22-46mm)
1. (Micro-tech, Mumbai.)
5. Packing & Labelling :-- Flat bottle labelling Machine (AHL 150)
a. (Ambica pharmaceutical, Mumbai.)
b. Automatic rotatory packing machine
1. (200 containers/minute.)
ii. (GMP Equipments.,Ahmedabad.)
QUALITY CONTROL SECTION
QUALITY:
A measure of excellence or a state of being free from defects, deficiencies and significant
variations.
QUALITY ASSURANCE:
Obtaining confidence that, required quality of product or service is satisfactory for their intended
use
QUALITY CONTROL:
Part of GMP concerned with sampling, testing and specifications.
Functions of QA in Pharmaceutical industry
➢ To prepare and approve Quality Policy, Quality Objectives, Quality Manual and
Validation Master Plan.
➢ Periodic Monitoring of the Quality Objectives.
28. ➢ Monitors all validation & stability activities are completed as per the schedule.
➢ Ensures that all changes impacting the product and the established systems are
documented and reviewed to analyze the impact.
➢ Ensures that all deviations, OOS/OOT & Market complaints are logged, investigated to
identify the root cause so as to take CAPA to prevent recurrence.
➢ Preparation of Annual product quality reports, trending of data, determining product and
process performance.
➢ To arrange and conduct the self inspection, identify gaps and take CAPA.
➢ Review of related batch manufacturing records and QC testing data Prior to release the
products.
Various Equipments Of Quality Control Department:---
1. Gas Chromatograph Cromline equipment, Mumbai.
2. Water bath Pathak ElectricWorks,Hyederabad.
3. Cesil HPLC Cromline equipment, Mumbai.
4. U.V. Dissolution Tester Electro lab, Mumbai.
5. Tablet Disintegration Tester Electro lab, Mumbai.
6. S.S. Tablet Inspection Machine Tab machine,Mumbai.
7. Tablet Hardness Tester Electro lab, Mumbai.
8. Tablet friabilator Electro lab, Mumbai.
9. Rotameter Huba control Switzerland.
10. Melting Point Appratus Bala ji Lab,Ahmedabad.
11. Leak Detector System Rajmal Mehata gp. Mumbai.
12. Visual Bottle Inspection Machine Rajmal Mehata gp. Mumbai.
13. Brock field Viscometer C.Abhay kumar co.,Mumbai.
14. Potentiometry Titrator Metrohm ltd. Switzerland.
15. U.V. Spectrophotometer Jyoti Machinary, Gwalior.
16. Autoclave Wintec Pharma.
17. Incubator Technopac Mumbai.
18. pH Meter Robertson machinary pvt.ltd. Japan. etc.
30. RAW MATERIAL STORAGE
Raw material storage is a sector of the manufacturing business that is essential to continuous
production operations. Everything from the production of steel parts for cars and trucks to silicon
for electronic components, including computers, comes originally from raw materials, and the
proper storage of these materials involves controlled temperature, humidity, and more.
Even in production lines for foodstuffs, ingredients must be stored in optimum conditions for
quality control purposes. Most pre-packaged food sold at the grocery store is a product of the
combining of many ingredients, all of which must be kept a certain way to maintain the quality
and freshness of these ingredients for when they are ready to be used.
Food storage sometimes involves keeping ingredients in refrigerated rooms for weeks at a time,
and the ingredients must then be thawed, either naturally or by machine, when they are ready to
go into production.
Raw material storage is something that companies have carefully engineered according to their
own unique storage needs to be able to produce a consistent product. Auto parts manufacturing
companies and auto repair shops keep a steady stock and rotation of materials in their facilities.
Spare parts storage is essential to the auto repair business, letting mechanics fix common
problems on cars and trucks without waiting days or weeks for parts to arrive from the
manufacturer. Automobile manufacturers also implement spare parts storage so they have parts
on hand that have already been made for current and recent models, ensuring that they can meet
the demand for parts from individuals, repair shops, and dealerships.
PREPARED AND STORAGE-
Pharmaceutical products should be packed in a well closed container that protects
the contents from contamination by extraneous solids, liquids or vapors and the
loss of the products under normal conditions of handling and storage. The following factors to
be taken in consideration for proper storage:
1. Sanitation
2. Temperature
3. Light
4. Moisture
5. Ventilation
31. 6. Segregation
Different pharmaceutical product storage temperature on the basis of stability studies as given
below:
Freezer: A place in which the temperature is maintained thermostatically between -25ºC and
10ºC (-13 ºF and -14 ºF).
Cold: Any temperature not exceeding 8ºC (46 ºF). A refrigerator is a cold.
Cool: Any temperature between 8 ºC and 15 ºC. Any pharmaceutical products for which
storage in a cool place directed may, alternatively, be stored in a refrigerator,
unless otherwise specified in the individual monograph.
Good storage practice (GSP) is applicable in all circumstances where
pharmaceutical products are stored through the distribution processes. For additional guidelines
relating the general principles of storage of pharmaceutical products, refer to the WHO
guidelines on good storage practices.
Storage condition on label
Storage conditions for pharmaceutical products and materials should be in compliance with the
labelling, which is based on the results of stability testing Storage conditions should be defined
and described on the label of the product. All drugs should be stored according to the conditions
described on the label. When specified on the label, controls for humidity, light, etc., should be
in place. Storage areas should be designed or adapted to ensure good storage conditions. The
label should specify any special storage conditions required for the product.
Storage of Tablet
Storage on label:
Store in a cool, protected from light and moisture.
Store in a cool and dark place, protected from light and moisture.
Keep in a dry dark place.
Store in cool dry and dark place.
Storage of Capsule
Storage on label:
Store in a cool and dry place, protected from light
Storage of syrup
The syrup should be stored in well closed and stopper bottle in a cool dark place. The syrup
should be stored at a temperature not exceeding 25 ºC.
Storage on label:
Store in cool, dry and dark place.
32. Store in a cool and dry place, protected from light.
33. Store in a cool place, protected from direct sunlight.
PACKAGING DEPARTMENT
Industrial packaging is an important part of the production process, allowing industrial grade
goods and products to be protected while they’re shipped and transported.It comes in a variety
of shapes and sizes, with various materials to choose between. Each product has its own
requirements when it comes to packaging, so it’s important to know which type of industrial
packaging works best in any given situation.
Industrial packaging is designed to both store and protect industrial goods. pIt is often purpose-
built or specifically tailored to suit particular products that are used on a large, industrial
scale. This can be anything from chemicals to concrete, so there is a broad range of industrial
packaging to suit the varied demands.
Industrial packaging needs to be robust and heavy-duty. It should make transportation and
storage easier, and it must be able to protect contents from bumps, dents, or spillage during
transit.
It is also required to label and track products, and in some cases to advertise them too. It often
comes with instructions or warnings on the outside, relating to the product stored within.
Materials used in industrial packaging
Industrial packaging comes in an array of shapes and sizes, but there are a few key materials
commonly found in their designs.
Steel
Industrial packaging often needs to be strong, hardwearing, resilient and reusable. Steel fits all of
those requirements, which is why it’s a great material for industrial transportation and
storage. You most commonly find steel in the form of steel drums, which are used to transport
liquids and semi-solids such as foodstuffs or oils. Steel frames are also used to provide extra
layers of protection for industrial products.
Plastic
Industrial packaging often comes in the form of plastic, which is sturdy, reliable and reusable.
Plastic drums are used to transport and store an array of liquids and foodstuffs, but they are also
used to transport corrosive and hazardous chemicals (and hazardous waste). It is cheap
to manufacture and can be easily moulded into a versatile range of shapes and sizes to fit many
industrial needs.
Cardboard
Cardboard is one of the most commonly used materials found in industrial packaging. The most
obvious use for cardboard is cardboard boxes. They are affordable, recyclable and come in a
huge variety of sizes. Cardboard boxes are surprisingly resilient. If you have heavy items in
need of protection, double-walled cardboard boxes provide a greater level of security.
34. Importance of industrial packaging
Industrial packaging is important for a variety of reasons. As mentioned above, it helps to protect
products while they are being stored in warehouses and while they are being shipped to their
destinations.
In many cases, industrial packaging allows products to be stored and transported safely,
especially if they’re potentially dangerous to human health (chemicals or hazardous substances,
for instance).
Even just for health and safety reasons, industrial packaging is indispensable. But it also helps to
label products and organise large amounts of the same product.