This document provides an overview of an internship at Arogya Jyoti Pharmacy. It discusses the various departments within the company including personnel and administration, raw material storage, production/manufacturing, quality control lab, quality assurance, and packaging. The production section describes the types of medications manufactured, including liquids, syrups, oils, ointments, and capsules. It provides details on specific products within each category. The document also includes pictures of machinery used in filling liquids, oils, ointments, and capsules.
Fda regulations for pharmaceutical packagingPrem Patil
The document discusses guidelines for packaging and labeling of active pharmaceutical ingredients (APIs). It outlines requirements for packaging materials, labeling, storage conditions, and expiration dating to ensure quality. Proper documentation of material specifications, examination and testing is required. Labels must include accurate information and be stored securely to prevent mix-ups. APIs should be packaged and labeled in a way that protects against deterioration and contamination during transport and storage.
The document discusses the scale-up process of parenteral formulations from the laboratory scale to full production. It explains that the pilot plant acts as an intermediate stage, where the formulation process is tested on a larger scale than the laboratory to work out any issues. This allows the process to be reliably transferred to full production scale. The document also describes the facilities, equipment, and controls needed for sterile production of parenterals, including cleanroom classifications and airflow, process steps, sterilization methods, and quality testing.
A Drug Master File (DMF) is a submission to the FDA that provides confidential detailed information about facilities, processes, or materials used in manufacturing drugs. There are 5 types of DMFs that cover manufacturing sites, drug substances and products, packaging materials, excipients, and other reference information. A DMF holder must authorize other applicants to reference their DMF and notify them of any changes. The DMF includes manufacturing and quality control procedures, validation data, and stability testing results.
The document contains details about a student named Srikanth Bandi enrolled in the Pharmaceutics department. It discusses accelerated stability testing, which involves exposing pharmaceutical products to elevated temperatures to simulate long-term shelf conditions over a shorter time period. The objectives and guidelines from the ICH are outlined, including storage conditions, sampling times, and test parameters. The document also describes the equipment used and process for conducting accelerated stability studies.
This document discusses technology transfer in the pharmaceutical industry. It begins by defining technology transfer as the process of applying technology developed in one organization or context to another. It then discusses the various aspects, types, and classifications of technology. The document focuses on the steps and processes involved in technology transfer for pharmaceutical development, including the research, development, and production phases. It outlines the key documentation and plans required for successful technology transfer, including development reports, specifications, transfer plans, and reports. The document emphasizes that effective communication and validation are important for technology transfer to ensure quality and consistency across organizations.
The document discusses the general principles, protocols, steps and methods involved in technology transfer. It defines technology transfer as the process of making a developer's technology available to a commercial partner. Key aspects of technology transfer covered include quality risk management, documentation, skilled personnel, comparison of equipment between sending and receiving units, process validation, and types of technology transfer agreements.
What is COPPs? How to apply for COPPs (Certificate of Pharmaceutical Products)?Ajay kamboj
The document discusses Certificate of Pharmaceutical Products (COPP), which is a certificate issued by the World Health Organization (WHO) that is required for pharmaceutical companies to export medicines globally. It regulates the import and export of drugs in India. To apply for a COPP, manufacturers must submit documents such as their manufacturing license, product lists, standard operating procedures, equipment lists, staff details and more to the relevant authorities. A COPP is valid for 3 years and helps ensure drugs meet quality standards before leaving the country.
PIC/S is a combine term used for the execution of activities of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
harmonize, educate, and update aspects relating to Good Manufacturing Practice among member countries
harmonized relation among regulatory authorities and governments
members
history
role
objective and function
guidlines
Fda regulations for pharmaceutical packagingPrem Patil
The document discusses guidelines for packaging and labeling of active pharmaceutical ingredients (APIs). It outlines requirements for packaging materials, labeling, storage conditions, and expiration dating to ensure quality. Proper documentation of material specifications, examination and testing is required. Labels must include accurate information and be stored securely to prevent mix-ups. APIs should be packaged and labeled in a way that protects against deterioration and contamination during transport and storage.
The document discusses the scale-up process of parenteral formulations from the laboratory scale to full production. It explains that the pilot plant acts as an intermediate stage, where the formulation process is tested on a larger scale than the laboratory to work out any issues. This allows the process to be reliably transferred to full production scale. The document also describes the facilities, equipment, and controls needed for sterile production of parenterals, including cleanroom classifications and airflow, process steps, sterilization methods, and quality testing.
A Drug Master File (DMF) is a submission to the FDA that provides confidential detailed information about facilities, processes, or materials used in manufacturing drugs. There are 5 types of DMFs that cover manufacturing sites, drug substances and products, packaging materials, excipients, and other reference information. A DMF holder must authorize other applicants to reference their DMF and notify them of any changes. The DMF includes manufacturing and quality control procedures, validation data, and stability testing results.
The document contains details about a student named Srikanth Bandi enrolled in the Pharmaceutics department. It discusses accelerated stability testing, which involves exposing pharmaceutical products to elevated temperatures to simulate long-term shelf conditions over a shorter time period. The objectives and guidelines from the ICH are outlined, including storage conditions, sampling times, and test parameters. The document also describes the equipment used and process for conducting accelerated stability studies.
This document discusses technology transfer in the pharmaceutical industry. It begins by defining technology transfer as the process of applying technology developed in one organization or context to another. It then discusses the various aspects, types, and classifications of technology. The document focuses on the steps and processes involved in technology transfer for pharmaceutical development, including the research, development, and production phases. It outlines the key documentation and plans required for successful technology transfer, including development reports, specifications, transfer plans, and reports. The document emphasizes that effective communication and validation are important for technology transfer to ensure quality and consistency across organizations.
The document discusses the general principles, protocols, steps and methods involved in technology transfer. It defines technology transfer as the process of making a developer's technology available to a commercial partner. Key aspects of technology transfer covered include quality risk management, documentation, skilled personnel, comparison of equipment between sending and receiving units, process validation, and types of technology transfer agreements.
What is COPPs? How to apply for COPPs (Certificate of Pharmaceutical Products)?Ajay kamboj
The document discusses Certificate of Pharmaceutical Products (COPP), which is a certificate issued by the World Health Organization (WHO) that is required for pharmaceutical companies to export medicines globally. It regulates the import and export of drugs in India. To apply for a COPP, manufacturers must submit documents such as their manufacturing license, product lists, standard operating procedures, equipment lists, staff details and more to the relevant authorities. A COPP is valid for 3 years and helps ensure drugs meet quality standards before leaving the country.
PIC/S is a combine term used for the execution of activities of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
harmonize, educate, and update aspects relating to Good Manufacturing Practice among member countries
harmonized relation among regulatory authorities and governments
members
history
role
objective and function
guidlines
Hot Melt Extrusion For Amorphous Formulationsasarode
The document discusses hot melt extrusion for amorphous formulations. It summarizes that about 40% of new APIs have poor solubility and are classified as Class II or IV in the Biopharmaceutical Classification System. Hot melt extrusion is presented as a continuous process that can transform crystalline drugs into amorphous forms through melting and mixing with polymers without using solvents. The document reviews the processing, performance, stability, and analytical characterization of drug-polymer hot melt extrudates using solubility parameters, thermal analysis, rheology, dissolution testing, and other techniques. It finds that hot melt extrusion improves drug dissolution by creating amorphous solid dispersions and that performance depends on drug-polymer interactions and pH conditions.
The document discusses the new rules for cosmetic regulation in India. Some key points:
- Cosmetics are now regulated under a separate comprehensive Cosmetics Rules 2020.
- Licenses for import and manufacturing are now lifetime registrations with reduced fees.
- Strict standards are outlined for ingredients, labeling, and testing of cosmetics.
- The Drugs Controller General of India regulates the import, manufacture, and sale of cosmetics and medical devices in the country.
The document discusses ICH Q7 guidelines for good manufacturing practices for active pharmaceutical ingredients. ICH Q7 provides guidance on GMP for manufacturing APIs to ensure quality, safety and efficacy. It covers requirements for facilities, equipment, documentation, materials management, production, packaging, labeling, testing, validation, and quality management. Adhering to ICH Q7 helps ensure consistent API quality and reduces batch variations.
Electronic submissions allow companies to submit regulatory applications like NDAs, BLAs, and INDs to agencies electronically instead of via paper. The eCTD format is now the preferred standard, organized into folders with an XML backbone and PDF files. Key benefits of electronic submissions include faster review times, elimination of duplicate documents, improved records management and archiving. While challenges remain, the future is a fully electronic environment across all FDA divisions to increase efficiency.
The Center for Drug Evaluation and Research (CDER) is responsible for protecting and promoting public health by ensuring the safety and effectiveness of human drugs. CDER oversees new drug development and reviews marketing applications, monitors drug safety after approval, and ensures quality in manufacturing. CDER's mission is to ensure that drugs are safe and effective for their intended use through activities like reviewing new drug applications, communicating drug information to health professionals and consumers, and facilitating innovation in drug development.
Scale up and post approval changes(supac)bdvfgbdhg
The document discusses guidelines for post-approval changes to drug products, including changes to batch size, manufacturing sites and equipment, and composition. It outlines 3 levels of changes - minor, moderate, and major - and provides recommendations for documentation and regulatory filings required for each level of change. Major changes, such as a new manufacturing site or changes in the amount of active ingredients, require more extensive documentation including stability testing and possibly bioequivalence studies.
pilot plant scale up techniques for tablets8669290285
The document discusses the scale up of tablet production from the laboratory scale to the pilot plant scale. It describes the various stages involved in tablet production such as material handling, dry blending, granulation, drying, milling, blending, compression, and coating. Scaling up from the lab scale to pilot plant scale requires adjustments to processing equipment, material handling procedures, blending times and speeds, drying methods, and compression equipment to optimize tablet properties such as content uniformity and hardness for production. The goal of the scale up process is to develop a reliable manufacturing process for producing viable tablet products.
Pharmaceutical packaging serves several important functions:
1) It protects drugs from external environmental factors like light, moisture, and contamination.
2) Packaging identifies drug products, provides instructions for proper use, and ensures safety and efficacy.
3) Packaging types include bottles, blister packs, vials, and other containers/closures that are evaluated through testing to ensure sterility, integrity, and that they do not interact with drug contents.
This presentation contains information about dossier preparation and submission as well as about CTD (Common Technical Document) which is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries.
Evaluation of transdermal drug delivery systemSagar Savale
This document discusses the evaluation of transdermal drug delivery systems. Key aspects that are evaluated include physicochemical properties, adhesive properties, in vitro studies, in vivo studies, stability studies, and toxicological studies. These evaluations are important to ensure consistency between batches in terms of quality, performance, reproducibility and stability, and to predict factors that may influence drug delivery.
Regulatory requirements for api registrationRiyaRYadav
The document discusses regulatory requirements for registering an active pharmaceutical ingredient (API). It explains that API registration requires submitting a dossier containing information about the quality of the API. This includes details on manufacturing, characterization, controls, and stability data. The dossier is submitted to health authorities for marketing authorization. It also describes drug master files (DMFs), which provide confidential API information to regulators, and notes their use in the US and EU registration processes. DMFs can reference other DMFs. The document outlines the organization and sections of electronic common technical documents (eCTDs) used to submit API information digitally.
The document discusses ICH Q7, a guideline for good manufacturing practices for active pharmaceutical ingredients. It aims to improve quality, enhance productivity and effectiveness of API manufacturing. ICH Q7 applies to APIs made through chemical synthesis, extraction, fermentation or combinations and establishes requirements for quality management, personnel, facilities, equipment, documentation, materials management, production controls, packaging and more. Adherence to ICH Q7 helps ensure APIs are safe, effective and of good quality and prepared according to cGMP standards expected by regulatory agencies like the FDA.
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
The document provides information on the Common Technical Document (CTD) format for organizing technical documents submitted to regulatory authorities for approval of pharmaceutical products. The CTD format was developed by the International Conference on Harmonization to streamline review processes and facilitate simultaneous submissions across different regions. It includes five modules covering administrative information, summaries, quality, nonclinical and clinical data. Adopting a common format provides benefits like reduced submission time and costs as well as faster availability of new medicines to patients.
Introduction,Drug- Excipient Compatibility Experimental Design ,Excipient role in drug destabilization,DRUG EXCIPIENT COMPATIBILTY IN PARENTERAL PRODUCTS.This topic are described.
paharmaceutical packaging Medical device Packaging types of medical device p...RavichandraNadagouda
This document discusses pharmaceutical packaging and different types of packaging materials used. It begins by defining packaging and outlining its key functions of protection, preservation, presentation, and promotion. It then discusses ideal qualities for pharmaceutical packaging and types of packaging including primary, secondary, and tertiary packaging. The document focuses on primary packaging materials and medical device packaging, outlining different package types used and characteristics of materials like Tyvek, films, foils, and thermoformable plastics.
Technology transfer is the process of sharing manufacturing knowledge, technologies, and processes between organizations. In the pharmaceutical industry, it refers to transferring a drug product from development to commercial manufacturing. Effective technology transfer requires careful planning, documentation exchange, verification of analytical methods, small-scale testing, and ensuring manufacturing processes are well-understood before full-scale production. It is a critical step to successful commercialization and requires consideration of regulatory requirements, personnel, manufacturing changes, and validation approaches.
The document discusses the Common Technical Document (CTD) format and electronic CTD (eCTD) format for new drug applications. The CTD format was agreed upon in 2000 and standardized the organization of application modules for quality, nonclinical, and clinical information. The eCTD is the electronic equivalent that regulatory agencies now require for application submissions. Key benefits of the eCTD include increased efficiency, reduced costs, and improved review processes through electronic submission and evaluation of drug applications.
PHARMACEUTICAL COMPANIES,INTELLECTUAL PROPERTY,AND THE GLOBAL AIDS EPIDEMICRakesh Bhaskar
This document discusses the issues around intellectual property rights (IPR) for pharmaceutical companies and access to HIV/AIDS drugs in developing countries. It provides details on:
- The US pharmaceutical industry initially opposing relaxation of IPR under WTO rules to allow generic drugs in developing countries like South Africa facing health crises.
- HIV/AIDS remaining a top global cause of death in 2008 despite decades of efforts, with most deaths in sub-Saharan Africa.
- The high costs of antiretroviral drug cocktails that made treatment unaffordable for most in developing countries.
- Pharmaceutical companies holding patents that limit competition from generic drugs and efforts by countries and organizations to expand access to affordable treatment
The document provides details about an industrial tour report submitted by Shubham Singh to Dr. A.P.J. Abdul Kalam Technical University. It includes a certificate signed by his supervisors, Dr. Abhay Kumar Verma and Mrs. Arpita Mishra, confirming the report fulfills requirements for his Bachelor of Pharmacy degree. The report also includes acknowledgements, an introduction to the pharmaceutical company visited, Nihal Health Care, and sections describing the manufacturing and packaging of products like syringes. It discusses a second company visited, Scott-Edil Advance Research Laboratories, which produces tablets, capsules, and other drug formulations.
The document provides an overview of the Alax Bioresearch Pvt. Ltd. pharmaceutical company, including its various departments and manufacturing processes. Key points:
- Alax Bioresearch is a nutraceutical company that manufactures tablets, capsules, and other supplements. It has departments for personnel, raw materials, production, quality control, packaging, and storage.
- The production department uses various instruments for tablet making including granulators, dryers, blenders, and compression machines. It also produces capsules, powders, and sachets.
- Raw materials are inspected following a flow chart before being approved for manufacturing. The quality control lab tests raw materials and finished products.
Hot Melt Extrusion For Amorphous Formulationsasarode
The document discusses hot melt extrusion for amorphous formulations. It summarizes that about 40% of new APIs have poor solubility and are classified as Class II or IV in the Biopharmaceutical Classification System. Hot melt extrusion is presented as a continuous process that can transform crystalline drugs into amorphous forms through melting and mixing with polymers without using solvents. The document reviews the processing, performance, stability, and analytical characterization of drug-polymer hot melt extrudates using solubility parameters, thermal analysis, rheology, dissolution testing, and other techniques. It finds that hot melt extrusion improves drug dissolution by creating amorphous solid dispersions and that performance depends on drug-polymer interactions and pH conditions.
The document discusses the new rules for cosmetic regulation in India. Some key points:
- Cosmetics are now regulated under a separate comprehensive Cosmetics Rules 2020.
- Licenses for import and manufacturing are now lifetime registrations with reduced fees.
- Strict standards are outlined for ingredients, labeling, and testing of cosmetics.
- The Drugs Controller General of India regulates the import, manufacture, and sale of cosmetics and medical devices in the country.
The document discusses ICH Q7 guidelines for good manufacturing practices for active pharmaceutical ingredients. ICH Q7 provides guidance on GMP for manufacturing APIs to ensure quality, safety and efficacy. It covers requirements for facilities, equipment, documentation, materials management, production, packaging, labeling, testing, validation, and quality management. Adhering to ICH Q7 helps ensure consistent API quality and reduces batch variations.
Electronic submissions allow companies to submit regulatory applications like NDAs, BLAs, and INDs to agencies electronically instead of via paper. The eCTD format is now the preferred standard, organized into folders with an XML backbone and PDF files. Key benefits of electronic submissions include faster review times, elimination of duplicate documents, improved records management and archiving. While challenges remain, the future is a fully electronic environment across all FDA divisions to increase efficiency.
The Center for Drug Evaluation and Research (CDER) is responsible for protecting and promoting public health by ensuring the safety and effectiveness of human drugs. CDER oversees new drug development and reviews marketing applications, monitors drug safety after approval, and ensures quality in manufacturing. CDER's mission is to ensure that drugs are safe and effective for their intended use through activities like reviewing new drug applications, communicating drug information to health professionals and consumers, and facilitating innovation in drug development.
Scale up and post approval changes(supac)bdvfgbdhg
The document discusses guidelines for post-approval changes to drug products, including changes to batch size, manufacturing sites and equipment, and composition. It outlines 3 levels of changes - minor, moderate, and major - and provides recommendations for documentation and regulatory filings required for each level of change. Major changes, such as a new manufacturing site or changes in the amount of active ingredients, require more extensive documentation including stability testing and possibly bioequivalence studies.
pilot plant scale up techniques for tablets8669290285
The document discusses the scale up of tablet production from the laboratory scale to the pilot plant scale. It describes the various stages involved in tablet production such as material handling, dry blending, granulation, drying, milling, blending, compression, and coating. Scaling up from the lab scale to pilot plant scale requires adjustments to processing equipment, material handling procedures, blending times and speeds, drying methods, and compression equipment to optimize tablet properties such as content uniformity and hardness for production. The goal of the scale up process is to develop a reliable manufacturing process for producing viable tablet products.
Pharmaceutical packaging serves several important functions:
1) It protects drugs from external environmental factors like light, moisture, and contamination.
2) Packaging identifies drug products, provides instructions for proper use, and ensures safety and efficacy.
3) Packaging types include bottles, blister packs, vials, and other containers/closures that are evaluated through testing to ensure sterility, integrity, and that they do not interact with drug contents.
This presentation contains information about dossier preparation and submission as well as about CTD (Common Technical Document) which is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries.
Evaluation of transdermal drug delivery systemSagar Savale
This document discusses the evaluation of transdermal drug delivery systems. Key aspects that are evaluated include physicochemical properties, adhesive properties, in vitro studies, in vivo studies, stability studies, and toxicological studies. These evaluations are important to ensure consistency between batches in terms of quality, performance, reproducibility and stability, and to predict factors that may influence drug delivery.
Regulatory requirements for api registrationRiyaRYadav
The document discusses regulatory requirements for registering an active pharmaceutical ingredient (API). It explains that API registration requires submitting a dossier containing information about the quality of the API. This includes details on manufacturing, characterization, controls, and stability data. The dossier is submitted to health authorities for marketing authorization. It also describes drug master files (DMFs), which provide confidential API information to regulators, and notes their use in the US and EU registration processes. DMFs can reference other DMFs. The document outlines the organization and sections of electronic common technical documents (eCTDs) used to submit API information digitally.
The document discusses ICH Q7, a guideline for good manufacturing practices for active pharmaceutical ingredients. It aims to improve quality, enhance productivity and effectiveness of API manufacturing. ICH Q7 applies to APIs made through chemical synthesis, extraction, fermentation or combinations and establishes requirements for quality management, personnel, facilities, equipment, documentation, materials management, production controls, packaging and more. Adherence to ICH Q7 helps ensure APIs are safe, effective and of good quality and prepared according to cGMP standards expected by regulatory agencies like the FDA.
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
The document provides information on the Common Technical Document (CTD) format for organizing technical documents submitted to regulatory authorities for approval of pharmaceutical products. The CTD format was developed by the International Conference on Harmonization to streamline review processes and facilitate simultaneous submissions across different regions. It includes five modules covering administrative information, summaries, quality, nonclinical and clinical data. Adopting a common format provides benefits like reduced submission time and costs as well as faster availability of new medicines to patients.
Introduction,Drug- Excipient Compatibility Experimental Design ,Excipient role in drug destabilization,DRUG EXCIPIENT COMPATIBILTY IN PARENTERAL PRODUCTS.This topic are described.
paharmaceutical packaging Medical device Packaging types of medical device p...RavichandraNadagouda
This document discusses pharmaceutical packaging and different types of packaging materials used. It begins by defining packaging and outlining its key functions of protection, preservation, presentation, and promotion. It then discusses ideal qualities for pharmaceutical packaging and types of packaging including primary, secondary, and tertiary packaging. The document focuses on primary packaging materials and medical device packaging, outlining different package types used and characteristics of materials like Tyvek, films, foils, and thermoformable plastics.
Technology transfer is the process of sharing manufacturing knowledge, technologies, and processes between organizations. In the pharmaceutical industry, it refers to transferring a drug product from development to commercial manufacturing. Effective technology transfer requires careful planning, documentation exchange, verification of analytical methods, small-scale testing, and ensuring manufacturing processes are well-understood before full-scale production. It is a critical step to successful commercialization and requires consideration of regulatory requirements, personnel, manufacturing changes, and validation approaches.
The document discusses the Common Technical Document (CTD) format and electronic CTD (eCTD) format for new drug applications. The CTD format was agreed upon in 2000 and standardized the organization of application modules for quality, nonclinical, and clinical information. The eCTD is the electronic equivalent that regulatory agencies now require for application submissions. Key benefits of the eCTD include increased efficiency, reduced costs, and improved review processes through electronic submission and evaluation of drug applications.
PHARMACEUTICAL COMPANIES,INTELLECTUAL PROPERTY,AND THE GLOBAL AIDS EPIDEMICRakesh Bhaskar
This document discusses the issues around intellectual property rights (IPR) for pharmaceutical companies and access to HIV/AIDS drugs in developing countries. It provides details on:
- The US pharmaceutical industry initially opposing relaxation of IPR under WTO rules to allow generic drugs in developing countries like South Africa facing health crises.
- HIV/AIDS remaining a top global cause of death in 2008 despite decades of efforts, with most deaths in sub-Saharan Africa.
- The high costs of antiretroviral drug cocktails that made treatment unaffordable for most in developing countries.
- Pharmaceutical companies holding patents that limit competition from generic drugs and efforts by countries and organizations to expand access to affordable treatment
The document provides details about an industrial tour report submitted by Shubham Singh to Dr. A.P.J. Abdul Kalam Technical University. It includes a certificate signed by his supervisors, Dr. Abhay Kumar Verma and Mrs. Arpita Mishra, confirming the report fulfills requirements for his Bachelor of Pharmacy degree. The report also includes acknowledgements, an introduction to the pharmaceutical company visited, Nihal Health Care, and sections describing the manufacturing and packaging of products like syringes. It discusses a second company visited, Scott-Edil Advance Research Laboratories, which produces tablets, capsules, and other drug formulations.
The document provides an overview of the Alax Bioresearch Pvt. Ltd. pharmaceutical company, including its various departments and manufacturing processes. Key points:
- Alax Bioresearch is a nutraceutical company that manufactures tablets, capsules, and other supplements. It has departments for personnel, raw materials, production, quality control, packaging, and storage.
- The production department uses various instruments for tablet making including granulators, dryers, blenders, and compression machines. It also produces capsules, powders, and sachets.
- Raw materials are inspected following a flow chart before being approved for manufacturing. The quality control lab tests raw materials and finished products.
1. The document summarizes the author's industrial training experience at Arogya Jyoti Pharmacy, an Ayurvedic drug manufacturing company.
2. It describes the various departments of the company including raw material storage, production, quality assurance, and quality control.
3. The training provided the author practical knowledge of pharmaceutical production processes and management that will help clarify their theoretical understanding for their future career.
Abhishek Ghara completed an industrial training at Gluconate Health Limited, a pharmaceutical manufacturing company in West Bengal.
[1] The company was formed through the merger of two companies in 1990 and is wholly owned by the government of West Bengal.
[2] Ghara thanks the managers and staff at the company for their cooperation and guidance during his training.
[3] He provides details of the company's production, quality control, packaging, and other departments as well as the instruments used and manufacturing processes for tablets, capsules, and liquids.
The document provides details about an in-plant training report submitted by 5 students from Southeast University at ACME Laboratories Ltd. It includes:
1) An introduction to the in-plant training and about ACME Laboratories which produces over 500 pharmaceutical products across various dosage forms and therapeutic categories.
2) Descriptions of the different production units at ACME including the General Unit, Solid Dosage Unit, Cephalosporin Unit, and the BFS, Liquid & Semisolid Unit.
3) Overviews of other departments visited including Quality Assurance, Quality Control, Warehouse, Engineering, and Research & Development.
This document provides an overview of Venus Glucose Pvt. Ltd., an Indian pharmaceutical company. It discusses the company's history since 1989, key milestones and expansions. The company has manufacturing facilities in India and Germany, and focuses on research and development, generics, and key therapeutic areas like analgesics, antibiotics and anti-diabetics. The document also outlines the company's vision, mission and focus on developing drugs for antimicrobial resistance. It introduces the executive team and provides an organizational structure.
This document reports on a student's industrial visit to the Uttar Pradesh Evertouch Healthcare Pharmacy in Kosi Kotwan, Mathura. It provides details on the company's facilities and production processes. The company produces various pharmaceutical dosage forms including tablets, capsules, syrups, and ayurvedic preparations. The report describes key production steps for these different forms such as granulation, blending, drying, punching, coating, filling capsules and syrups. It also discusses quality control processes to ensure product quality.
Industrial training report pharmaceutical companiesMunish Kumar
Munish Kumar completed an industrial training at Eurolife Healthcare Pvt. Ltd. as part of his Bachelor of Pharmacy degree requirements. Eurolife Healthcare manufactures and distributes tablets, intravenous infusions, and other healthcare products. During his 4-week training, Munish observed and gained experience in various production processes including raw material handling, tablet formulation, compression, coating, packaging, and quality control testing. He expressed gratitude to the staff at Eurolife Healthcare and his college for enabling this valuable practical learning experience.
Pravash Patel submitted an industrial tour report from his visits to several major pharmaceutical companies in India. The tour included visits to Dr. Reddy's Laboratories in Hyderabad, Disto Pharmaceuticals in Hyderabad, IPC in Chennai, and Karnataka Antibiotics Limited in Bangalore. At each site, Pravash observed their manufacturing facilities and processes and learned about their product offerings and therapeutic areas. The report provides details on the production lines, quality control systems, and key products of each company visited during the tour.
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 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/
PHARMACEUTICAL INDUSTRIAL TRAINING REPORT .pdfRonakBhambri
This document provides an overview of an industrial training report submitted by Ronak Bhambri at Laborate Pharmaceuticals Ltd. regarding the production of tablets. It includes a declaration by Ronak, a training certificate, and acknowledgements. The report then covers various aspects of the tablet production process at the facility including sizing, powder blending, granulation, drying, tablet compression, coating, packaging and evaluation. It provides details on the machinery and processes used at each stage of tablet manufacturing. The trainee expresses gratitude for the learning experience and opportunity to gain practical experience in the pharmaceutical industry.
This document is an industrial training report submitted by Rohit Yadav to partially fulfill the requirements of a B.Pharma degree. It summarizes Rohit's one month internship at NAVKAR LIFESCIENCE Pvt. Ltd, including an overview of the company and acknowledgements. The report then describes the various sections and processes involved in pharmaceutical manufacturing, with a focus on tablet and capsule production processes, equipment used, and quality control procedures.
Kemiko Pharmaceuticals Ltd is one of the leading pharmaceutical companies in Bangladesh, established in 1986. It manufactures over 200 allopathic and herbal products as well as 33 animal health products. KPL has a nationwide distribution network covering all areas of Bangladesh and is working to export its products internationally, having already exported to countries such as Cambodia, Myanmar, Bhutan, and Guatemala.
The document is an industrial training report submitted by Ashwani Kumar for partial fulfillment of a Bachelor of Pharmacy degree. It provides details of Ashwani's 6-week industrial training at Dhanuka Laboratories Limited in Gurgaon, including an overview of the company and its products, descriptions of key manufacturing sections like granulation, blending, compression and coating, and summaries of quality control and packaging operations. The report contains certificates, acknowledgements and declarations as required.
Lifezen Healthcare Pvt. Ltd. is a healthcare brand that aims to develop innovative healthcare offerings that provide the ultimate care of life and well-being. We specialize in over - the - counter (OTC) products in different therapeutic segments, and we aim to become a comprehensive OTC healthcare organization.
This document provides information about Sahayog Clean Milk Private Limited, including its introduction, products, management commitment, vision, mission, and materials and methods used. Specifically:
- It establishes the company's certifications and details its rapid growth serving over 500 villages and 10,000 farmers.
- The company processes 50,000 liters of milk per day into products like various types of milk, curd, paneer, and ghee.
- Materials and methods used in testing and analysis include equipment like an autoclave, centrifuge, and pH meter as well as reagents and glassware.
- Test results on samples are provided to check if they meet government standards for SPC, col
This document summarizes an internship report promoting the malaria drug COMBIART® at AGIPRO-PHARMA agency in Yaounde, Cameroon. Over three months, the intern conducted medical sales visits, meeting around 100 contacts and 60 prospects at health centers, hospitals, and pharmacies to introduce COMBIART®. A SWOT analysis found AGIPRO-PHARMA's strengths include educational meetings, while weaknesses are some out-of-stock products and unexploited areas. For the training center CHANING FP, strengths are qualified teachers but weaknesses include a lack of library/study areas. The internship helped the individual gain experience in medical visits and working under pressure.
LinkedIn for Your Job Search June 17, 2024Bruce Bennett
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Dhavalsinh Solanki_172230290047 Indukaka Ipcowala College of Pharmacy-223
INDUSTRIAL TRAINING REPORT FOR PRACTICE SCHOOL
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Dhavalsinh Solanki_172230290047 Indukaka Ipcowala College of Pharmacy-223
ACKNOWLEDGEMENT
I consider its great privilege & honour to had the opportunity to undergo the industrial training work at
Arogya Jyoti Pharmacy. Hence, I would like to offer my heartiest thank to Mr. kirtisinh Rajput
(Managing Director).I am greatly indebted to Yogendrasinh Rajput for enabling me to have the chance
of industrial training and sponsoring such a nice arrangement. Thank you so much for paying attention
to me and teaching me very important skills and sharing your knowledge with me.
PREFACE
Pharmacy is a profession which is concerned with the art and science of preparing suitable and
convenient material for distribution and use for treatment, prevention of diseases, so it is a fully
technical profession where practical knowledge is much more important along with theoretical
knowledge.
According to curriculum of a four-year integrated degree course of BACHELOR OF PHARMACY,
each student has to undergo training period of around 150 hours in various field.
I was directed to undergo the industrial training at “Aarogya Jyoti Pharmacy” and this report contain
a brief description about the above pharmaceutical industry which I had selected for my internship
period.
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INDEX
Sr.no. Title Pg. No.
1 Introduction 4
2 Schematic layout of industry 5
3 Personal and administration 6
4 Raw material department 7
5 Production (manufacturing) 9
6 Laboratory QC room 21
7 Quality assurance 24
8 Quality control 25
9 conclusion 26
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1. INTRODUCTION
ABOUT AROGYA JYOTI
AROGYA JYOTI PHARMACY is founded in 1994, now the fastest growing Ayuervedic company.
The company is a leading provider of high-quality products and service to its customers. The house of
AROGYA JYOTI PHARMACY offer hi-tech therapeutics well assured for quality. Arogya Jyoti
Pharmacy ethical range of formulations are as per global standard GMP, & as per schedule
compliance. It is needless to mention that there is strong need of quality control & standardization for
the high-profile herbal healthcare formulations. House of AROGYA JYOTI PHARMACY is strongly
committed in this context, to offer well standardized herbal extract/remedies ensured for Authenticity,
Purity, and Quality & Proven clinical efficiency.
VISION
Built around a desire to being not just the best but a leader in developments, manufacturing & sales of
premium personal care & healthcare products. Our focus stays in launching new products to widen the
scope of our portfolio and to offer a complete range of customers.
LOCATION
59, V P Road, Vithal Udyognagar, GIDC, Vithal Udyognagar, Anand, 388121
Gujarat. Email- arogyajyoti@gmail.com,www.arogyatipharmacy.com
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AROGYA JYOTI PHARMACY
Fig.1.SCHEMATIC LAYOUT OF INDUSTRY
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Industry Include Different Department Like…
1. Personnel and administration
2. Raw material department
3. Production (Manufacturing)
4. Quality Control lab
5. Quality Assurance
6. Packaging
7. Store
3. PERSONAL AND ADMINISTRATION
Personnel in simple words is a management in which people employed in an organization or engaged
in an organized undertaking such as military service.
Administration means the process or activity of running a business, organization, etc.
Here I was instructed how to behave and how to carry out the work given by the official.
The range of clothing available would normally include:
• Hats or hair cover
• Beard and moustache cover
• Coveralls - preferably with no pockets or pockets suitably designed to prevent articles falling out
• Disposable gloves
• Foot covers and shoes
• Masks
• Safety glasses or goggles
• Appropriate clean room suits for sterile areas
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4. RAW MATERIAL DEPARTMENT
Raw material storage is a sector of the manufacturing business that is essential to continuous
production operations. 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.
In raw material storage room different types of raw materials like sugar, polymers, herbs, oils, seeds
etc. are stored as per requirements of industry. Different boxes and drums are placed in raw material
storage room.
Before using raw materials for production of medicines there is a checking process of received raw
material.
The below flow chart is followed for checking of raw material.
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Fig.2.FLOW CHART FOR RM/PM INSPECTION
6.Flow chart for RM/PM inspection
Raw material Packaging material
Receipt
Verification
Sampling
Under Test
Q.C. Testing
Approved Rejected
For Manufacturing Return to Supplier /
Destruction
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5. PRODUCTION(MANUFACTURING)
At Arogya Jyoti pharmacy different types of medications are manufactured. they are as follow
1. Liquid(drops)
2. Syrup
3. Oil
4. Ointment
5. Capsule
1) Liquids(drops)
1. Digivit – U drops (30 ml)
• Anti-spasmodic
• Digestive upset
• Carminative diarrhoea
• Source of vitamin c
• Help in digestion of milk
2. U – Ton drops (30ml)
• Protect the liver enzyme
• Used against various toxic of hepatitis
• Increase haemoglobin
• Iron liver tonic
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3. Artirol-U drops (30 ml)
• Cough and cold
• Respiratory trac infection
• Diarrhoea
• Spasmodic pain
4. Udiared drop (30 ml)
• Cure summer diarrhoea
• Help diarrhoea & dysenteries infection
• Support treatment of diarrhoea
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2) SYRUP
1. Balrakshak syrup (110ml)
• Help in colic
• Vomiting and diarrhoea
• Digestive upset
• Healthy growth
• Help for digestion of milk
2. Asmasol cough syrup (50 ml & 110 ml)
• Inflammatory catarrhal condition
• Common cold allergic
• Spasmodic cough
• Bronchodilator
• Sure-throated & respiratory tract infection
3. Kofjil cough syrup (110 ml & 50 ml)
• Allergic and asthmatic cough
• Acute & bronchitis
• Used in Asthma
• Different type of cough
• Allergic dry or productive bronchitis
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4. Lohayog syrup (110, 200, 450 ml)
• An ideal hematinic tonic for all ages
• In deficiency of iron naturally
• Contain iron and calcium
• Digestive and metabolic power
• Increase haemoglobin in blood
5. Liverton syrup (110, 200 ml)
• An ideal livertonic
• Fatty liver, tropical in rontile
• Cirrhosis of liver
• Jaundice and hepatitis
• Used in anorexia
6. Noni (dew syrup 400ml & 500ml)
• Antioxidant
• Antidiabetic
• Anti-cancer
• Immunity Promoter
• Children healthy growth
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3. OIL
Fig.3.Oil filling machine
The above picture shows the process of oil filling in bottle, at one time 50 ml oil filled in the bottle, the
volume of oil to be filled in bottle can be manually adjusted. Like 30 ml, 50 ml, 100 ml at the time two
bottle are filled with oil and then go for capping and labelling.
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1. Rumajin oil (50 ml, 100 ml)
• Joint pain and inflammation
• Backache and arthritic disorder
• Sprains and swelling
• Anti-rheumatic and joint pain
2. Rhu Dpain oil (60ml)
• Joint pain and inflammation
• Backache and arthritic disorder
• Sprains and swelling
• Anti-rheumatic and joint pain
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4) OINTMENT
Fig.4.Ointment filling and sealing machine
▪ Ointment filing machine have capacity of 20 kg from single batch of the machine nearly 650
ointment tubes are prepared.
▪ Ointment sealing machine seal the tip of ointment tube. At the time two tubes can sealed by the
machine.
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1. Rumajin ointment (30gm)
• Joint pain and inflammation
• Backache and arthritic disorder
• Sprains and swelling
• Anti-rheumatic and joint pain
2. Jilpil ointment (30gm)
• Used in all types of bleeding piles
• Fissure
• Haemorrhoids
• Constipation
3. Purex ointment (20gm)
• Effectively cure all skin disease
• Leprosy
• Crack and black spot
• Anti-fungal and anti-bacterial
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5) CAPSULES
INSTRUMENTATION
Fig.5. Capsule Loader Machine and filling machine
▪ Capsule filling machine capacity 300 capsule fill in one plate and also have same capacity of
loader machine.
▪ Capsule size is also important parameter in area. Mostly use size 2” capsule for filling.
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Fig.6. Different size and detail structure of capsule
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1. Gengo (30 capsules)
• Effect on viscosity & motility of sperm
• Female improve the uterine circulation
• Tones up system
• Men’s physical mental well being
2. A Ufit (30 capsules)
• Effect on wight reducer
• Stimulate glandular function
• Overweight
• Maintains figure
3. 5 Steps (30 capsules)
• Helps in sciatica
• Joint pain
• Low back pain
• Muscle pain
• Knee joint
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4. Siddh Dayayog (60 capsules)
• Non-insulin dependent diabetes mellitus (NIDDM, Types 2)
• Associated symptoms
• Help to reduce elevated blood glucose level
5. Ashwagandha (60 capsule)
• Reduce blood sugar level
• Anti-cancer
• Reduce cortisol levels
• Reduce stress and anxiety
• Boost testosterone in men
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6. LABORATORY QC ROOM
In the laboratory different analytical instrument are placed for checking the quality of finished products
and maintaining the regulation of GMP guidelines
1. pH meter
• A pH meter is an instrument used to measure acidity or
alkalinity of a solution - also known as pH. pH is the unit
of measure that describes the degree of acidity or alkalinity.
It is measured on a scale of 0 to 14.
Fig.7.pH Meter
2. Magnetic stirrer
• A magnetic stirrer or magnetic mixer is a laboratory device that employs a
rotating magnetic field to cause a stir bar (or flea) immersed in a liquid to spin very
quickly, thus stirring it.
Fig.8.Magnetic Stirrer
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3. Disintegration apparatus
• Disintegration Tester is a solid-state instrument designed for the accurate estimation
of disintegration time of tablets as per IP/USP standards. The instrument is designed
to test two batches of six tablets, simultaneously. The unit is extremely useful for
pharmaceutical industries.
Fig.9.Disintegration Apparatus
4. Freeze thaw test apparatus
• Freeze thaw test conducted by placing the sample in a freezer for 18 hrs followed by
throwing it room temperature for 4 – 6 hrs. repeat the freeze throw cycle for 10 times.
This test is conducted to determine the tendency to crystalized or colour.
Fig.10.Freeze Thaw Apparatus
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5. OVEN
• Laboratory ovens are ovens for high-forced volume thermal convection applications.
These ovens generally provide uniform temperatures throughout. Process applications for
laboratory ovens can be for annealing, die-bond curing, drying, Polyimide baking,
sterilizing, and other industrial laboratory functions.
Fig.11.Oven
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7. QUALITY ASSURANCE
The Q.A department is a wide-ranging concept covering all matters that individually or collectively
influence on the quality of a product.
It is concerned with all the in-process quality assurance [IPQA].
Here, I came to know all the basic information about the department in detail.
The objective of this department is to provide the best quality material and assure safety.
It ensures that the unit performs as per GMP, GLP, and GWP.
QA is the heart and soul of quality control.
QA = QC + GMP
The QUALITY MANAGEMENT mainly focus on:
1. QUALITY ASSURANCE
2. QUALITY checking by GLP
3. GMP
4. GWP
5. GDP
6. RAINING & DEVELOPMENT
7. INSPECTIO
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8. QUALITY CONTROL
A system of maintaining standards in manufactured products by testing a sample of the output against
the specification.
QC department has following roles: -
The quality control is the department which is related with the different parameters of the quality
control.
The Q.C department is connected to 5 different departments:
1. Raw material
2. Finished product
3. Stability
4. Packing material
5. Microbiology
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9. CONCLUSION
Industrial training is very much essential for Pharmacy Students, it is also a great opportunity to
acquire practical knowledge.
During my training period, in the industry I acquired lots of experiences in Pharmaceutical Production
and Production management.
I have seen the various instruments and apparatus in the industry and their functions.
This will help me to clarify my theoretical knowledge. I hope and pray that it will help me much in
my future profession, during my training period.
❖