This document discusses Good Manufacturing Practices (GMP) for pharmaceuticals. It introduces GMP, explaining that GMP ensures pharmaceutical products are consistently manufactured and controlled to quality standards for their intended use. It also discusses the relationships between quality assurance (QA), GMP, and quality control (QC), noting that QA oversees the whole system, GMP ensures consistent manufacturing quality, and QC tests samples to ensure quality. Finally, it provides an overview of key aspects of GMP, including facilities, equipment, packaging, and documentation.
1) GMP (Good Manufacturing Practice) guidelines are important regulations that help ensure animal vaccines and other drugs/medical products are produced safely and are effective. They cover all aspects of production from materials to equipment to staff training.
2) Key components of GMP include quality management, quality control, sanitation, validation, documentation and more. Strict adherence to GMP helps reduce risks like contamination and errors that could harm patients.
3) For animal vaccines specifically, following GMP is critical given the live organisms involved and safety precautions needed. Facilities must be designed to properly handle biosafety requirements as well as aseptic processing.
This document provides an overview of key elements and basic principles of Good Manufacturing Practices (GMP). It defines GMP and cGMP, outlines their importance in ensuring product quality and safety, and describes characteristics of GMP-compliant products. The document also summarizes key elements of GMP like personnel, premises, equipment, materials, and quality control. It emphasizes the importance of documentation, validation, recalls, self-inspection, storage and training in adhering to GMP. The objectives of GMP and guidelines from various regulatory bodies are also briefly mentioned.
GMP in Pharmaceutical Industry by Dr.A S CharanCharan Archakam
The document provides an overview of Good Manufacturing Practices (GMP) guidelines from various regulatory bodies around the world such as the US FDA, WHO, EU, and India. It discusses the history and development of GMP guidelines and regulations. It also summarizes some key GMP guidelines including the US FDA's 21 CFR Parts 210 and 211, WHO's GMP guidelines, ICH Q7 guidelines for APIs, and India's Schedule M under the Drugs and Cosmetics Act. The document further highlights some historical incidents due to lack of GMP compliance and the importance of following GMP guidelines.
This document discusses Good Manufacturing Practices (GMP) for pharmaceuticals. It introduces GMP, explaining that GMP ensures pharmaceutical products are consistently manufactured and controlled to quality standards for their intended use. It also discusses the relationships between quality assurance (QA), GMP, and quality control (QC), explaining that QA oversees the whole system, GMP is the quality system for manufacturing, and QC tests samples of products. Current good manufacturing practices (cGMP) are also introduced as the GMP regulations enforced by the FDA to control manufacturing operations and assure drug identity, strength, quality and purity.
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.
Indian GMP Certification & WHO GMP CertificationVishal Shelke
Indian GMP Certification & WHO GMP Certification by Mr. Vishal Shelke
https://youtube.com/vishalshelke99
https://instagram.com/vishal_stagram
Sub :- Drug Regulatory Affairs
M.Pharm Sem II
Savitribai Phule Pune University
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.
1) GMP (Good Manufacturing Practice) guidelines are important regulations that help ensure animal vaccines and other drugs/medical products are produced safely and are effective. They cover all aspects of production from materials to equipment to staff training.
2) Key components of GMP include quality management, quality control, sanitation, validation, documentation and more. Strict adherence to GMP helps reduce risks like contamination and errors that could harm patients.
3) For animal vaccines specifically, following GMP is critical given the live organisms involved and safety precautions needed. Facilities must be designed to properly handle biosafety requirements as well as aseptic processing.
This document provides an overview of key elements and basic principles of Good Manufacturing Practices (GMP). It defines GMP and cGMP, outlines their importance in ensuring product quality and safety, and describes characteristics of GMP-compliant products. The document also summarizes key elements of GMP like personnel, premises, equipment, materials, and quality control. It emphasizes the importance of documentation, validation, recalls, self-inspection, storage and training in adhering to GMP. The objectives of GMP and guidelines from various regulatory bodies are also briefly mentioned.
GMP in Pharmaceutical Industry by Dr.A S CharanCharan Archakam
The document provides an overview of Good Manufacturing Practices (GMP) guidelines from various regulatory bodies around the world such as the US FDA, WHO, EU, and India. It discusses the history and development of GMP guidelines and regulations. It also summarizes some key GMP guidelines including the US FDA's 21 CFR Parts 210 and 211, WHO's GMP guidelines, ICH Q7 guidelines for APIs, and India's Schedule M under the Drugs and Cosmetics Act. The document further highlights some historical incidents due to lack of GMP compliance and the importance of following GMP guidelines.
This document discusses Good Manufacturing Practices (GMP) for pharmaceuticals. It introduces GMP, explaining that GMP ensures pharmaceutical products are consistently manufactured and controlled to quality standards for their intended use. It also discusses the relationships between quality assurance (QA), GMP, and quality control (QC), explaining that QA oversees the whole system, GMP is the quality system for manufacturing, and QC tests samples of products. Current good manufacturing practices (cGMP) are also introduced as the GMP regulations enforced by the FDA to control manufacturing operations and assure drug identity, strength, quality and purity.
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.
Indian GMP Certification & WHO GMP CertificationVishal Shelke
Indian GMP Certification & WHO GMP Certification by Mr. Vishal Shelke
https://youtube.com/vishalshelke99
https://instagram.com/vishal_stagram
Sub :- Drug Regulatory Affairs
M.Pharm Sem II
Savitribai Phule Pune University
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.
This document discusses organizational structures for pharmaceutical quality assurance. It states that the heads of production and quality control must be independent of each other according to EU GMP guidelines. It also lists the typical educational backgrounds needed for various roles in pharmaceutical production, quality assurance/quality control, and management. Finally, it provides a flow chart illustrating the process flow from receiving to shipping in a pharmaceutical manufacturing facility.
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
The European Commission Health and Consumers Directorate – General has published a draft “GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE”.
The guideline addresses Quality systems, Personnel, Documentation, Order, Procedures, Records, Premises and Equipment, Receipts, Storage , Deliveries to Customers, Transfer of Information and Returns.
Following presentation is prepared by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional.
Good Manufacturing Practice (GMP) 2day course Jo Havemann
The following topics were presented to the participants through lectures, group discussions and exercises during 16 hours:
- Core values and guidelines of Good Laboratory Practice (GLP)
- Factors that might lead to questionable research & manufacturing practices and their impact
- GMP compliance, national & international regulations, guidelines and authorities
- Quality Management and Assessment
- Digital GMP Solutions
This document is the 2014 annual report of the Taiwan Food and Drug Administration (TFDA). It discusses the TFDA's organizational structure, administrative objectives, policies and regulations for managing food, medicinal products, medical devices and cosmetics. Key highlights include strengthening food safety laws, shortening drug review timelines, expanding medical device sales channels, increasing border inspections, and enhancing international cooperation. The TFDA aims to safeguard public health through a five-pronged strategy of ensuring a stable management system, controlling product imports and manufacturing, overseeing distribution, and protecting consumers.
Who good distributionpracticesforpharmaceuticalproductsadeelzia84
The document summarizes the history and contents of the WHO Good Distribution Practices for Pharmaceutical Products guidelines. It was originally adopted in 2005 and revised in 2009 to improve security against counterfeit medicines. The goals are to ensure quality and identity of pharmaceuticals during distribution. It defines distribution and outlines general principles like traceability and responsibilities across the supply chain. Key points covered include regulations, personnel training, documentation, repackaging, recalls, investigating counterfeits, and next steps to finalize the guidelines.
HACCP (Hazard Analysis Critical Control Point) is a food safety system that identifies potential food safety hazards and puts controls in place to prevent them. It was originally developed in the 1960s for NASA space missions to ensure food safety. Since then, HACCP principles have been adopted worldwide by food standards organizations and legislation. The document provides a detailed history of the development of HACCP from 1959 to the present and describes the seven principles of HACCP and guidelines for its application, which include assembling a HACCP team, describing products, identifying intended uses, constructing flow diagrams, identifying hazards and controls, determining critical control points, and establishing monitoring, verification and documentation procedures.
Internship report for pharmaceutical industryRai Waqas
Envoy Pharmaceutical is an ISO certified pharmaceutical company located in Lahore, Pakistan. The internship report summarizes the company's departments and manufacturing processes. Key departments include warehousing, production, and quality control. The production department manufactures tablets, capsules, oral liquids, and injectables using modern equipment according to cGMP standards. Raw materials are received and tested before use. Finished products are packaged and labeled for distribution. The report provides an overview of Envoy Pharmaceutical's operations during the author's internship.
The document discusses Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGMP). It defines GMP as ensuring products are consistently manufactured and controlled according to quality standards for their intended use. cGMP emphasizes that expectations are dynamic and evolve over time. The document outlines several key GMP considerations including organization and personnel qualifications, facility and equipment design, production and process control, packaging and labeling, handling and distribution, and documentation through records and reports.
Quality Perspective of ‘Good Distribution Practices’ in Indian Pharmaceutical...iosrjce
This document discusses quality issues that can arise during the distribution of pharmaceutical products in India. It notes that good distribution practices (GDP) are important to ensure quality from manufacturing to retailers. A survey of pharmaceutical professionals found the biggest concern was illegible product information on labels/packaging, which could result from issues like label scratching or ink smudging during distribution. Other potential quality defects discussed include product degradation from improper temperature control, contamination from seal breaks, and absorption of smells/tastes from shared cargo transit. The document emphasizes that distribution practices need to be carefully controlled and aligned with good manufacturing quality standards to avoid defects that could compromise patient health and safety.
This document provides an overview of ICH Q10, which describes a pharmaceutical quality system model based on ISO quality concepts and GMP regulations. The quality system can be implemented throughout a product's lifecycle to facilitate innovation, continual improvement, and strengthen the link between development and manufacturing. ICH Q10 augments GMPs by describing specific quality system elements and management responsibilities to achieve product realization, establish state of control, and facilitate continual improvement.
The document compares regulatory standards for Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). It finds that GMP places more emphasis on maintaining quality during product manufacturing, while GDP guidance for distribution is less extensive. Both are important quality systems, but GMP requirements for manufacturing processes are more rigorous. Pharmaceutical companies should design quality systems that ensure product quality is maintained during both manufacturing and distribution operations.
Pharmaceutical manufacturing has become a significant industry in India. It has been estimated that has the third largest pharmaceutical industry by volume We will examine how well they comply with Good Manufacturing Practices (GMP).
The International Council for Harmonisation (ICH) brings together regulatory authorities and the pharmaceutical industry to discuss technical requirements for drug registration. ICH has produced guidelines on quality, safety, efficacy, and multidisciplinary topics. The quality guidelines cover stability testing, analytical validation, impurities, Good Manufacturing Practice, and quality risk management. Together, the ICH guidelines aim to harmonize technical requirements across regions to provide efficient drug development and approval.
Losses due non-compliance with China food regulation and how to overcome Chi...Rong Liu
As the world’s largest imported food market, China imported totally 38 billion US dollars food products from187 countries in 2016.
The growing China market has attracted a lot of interest from different countries over the world. Meanwhile China government has, over the last years, developed a tougher and tougher food regulation regime to regulate the market and ensure food safety.
Due to various challenges (languages, resources, information accessibility etc.), foreign SMEs learned a lot lessons and experienced big losses due to non-compliance with Chinese regulations.
Actually majority of these losses due non-compliance can be easily prevented if SMEs have reliable regulatory information in hand.
As a leading Chinese food regulation consulting company, FoodMate developed “Compliance Excellence” information service product for foreign SMEs with target to minimize your losses due regulatory non-compliance by assessing reliable and tailor made regulatory information.
This document provides an overview of Hong Kong's food safety framework and incidents relating to food additives. It describes the organization of the Food and Environmental Hygiene Department and the Centre for Food Safety, which oversees food surveillance programs. The legal framework for regulating food additives is also outlined. Recent surveillance results from 2011-2013 found some meat, vegetable and fruit samples containing excessive levels of preservatives like sulphur dioxide. Case examples are also presented, such as the detection of sulphur dioxide in some meat intended for raw consumption. The overall compliance rate for food additive regulations has improved according to the trend data shown.
This document summarizes the key impacts of China's new Food Safety Law on infant formula, health foods, and special dietary foods. It discusses increased regulations for infant formula, including whole process quality control, product registration, and restrictions on sub-packaging and using the same formula for different brands. It also outlines the import process for infant formula and challenges import companies may face, such as ensuring formulas are registered and formulations comply with local policies.
The document outlines the key aspects of current good manufacturing practices (cGMPs) that pharmaceutical manufacturers must follow. cGMPs come from the Food, Drug and Cosmetic Act and are enforced by the FDA. They help ensure safety and quality by requiring strict control over facilities, equipment, components, packaging, labeling, and processes. Key parts of cGMP regulations address organization, buildings, equipment, materials control, production, packaging, holding, distribution, and records. Failure to comply can result in serious legal and business consequences like product recalls or plant shutdowns.
Food Safety, Hygiene and Food Quality AssuranceTUVSUDIndia
modern food safety and hygiene testing practices ensure that
the food products are contamination-free and act in accordance with national and international food
safety and hygiene standards. Known to be one of the most trusted names in the food safety and
hygiene industry, TÜV SÜD has been helping businesses with food safety and quality services including
testing, auditing, training, certification, and regulatory compliance. Find out more about our food safety
and hygiene management services here, https://www.tuvsud.com/en-in/industries/consumer-products-and-retail/food/food-training
The European Commission Health and Consumers Directorate – General has published draft “GUIDELINES ON THE FORMALISED RISK ASSESSMENT FOR ASCERTAINING THE APPROPRIATE GOOD MANUFACTURING PRACTICE FOR EXCIPIENTS OF MEDICINAL PRODUCTS FOR HUMAN USE” for public consultation.
Following presentation has been prepared by " Drug regulations" a not for profit organization which provides free online resources for the Pharmaceutical Professional.
Good Manufacture Practices Pharmaceutical technologyafsanamamedova
The document discusses Good Manufacturing Practices (GMP) which are a system for ensuring that products are consistently produced and controlled according to quality standards. It covers GMP guidelines from various organizations, key aspects of GMP like packaging and facilities, and concepts like quality assurance, quality control, documentation practices. GMP is important for minimizing risks in pharmaceutical production and ensuring medicine quality and safety. Adherence to GMP regulations is necessary for pharmaceutical manufacturers and exporters.
the all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
This document discusses organizational structures for pharmaceutical quality assurance. It states that the heads of production and quality control must be independent of each other according to EU GMP guidelines. It also lists the typical educational backgrounds needed for various roles in pharmaceutical production, quality assurance/quality control, and management. Finally, it provides a flow chart illustrating the process flow from receiving to shipping in a pharmaceutical manufacturing facility.
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
The European Commission Health and Consumers Directorate – General has published a draft “GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE”.
The guideline addresses Quality systems, Personnel, Documentation, Order, Procedures, Records, Premises and Equipment, Receipts, Storage , Deliveries to Customers, Transfer of Information and Returns.
Following presentation is prepared by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional.
Good Manufacturing Practice (GMP) 2day course Jo Havemann
The following topics were presented to the participants through lectures, group discussions and exercises during 16 hours:
- Core values and guidelines of Good Laboratory Practice (GLP)
- Factors that might lead to questionable research & manufacturing practices and their impact
- GMP compliance, national & international regulations, guidelines and authorities
- Quality Management and Assessment
- Digital GMP Solutions
This document is the 2014 annual report of the Taiwan Food and Drug Administration (TFDA). It discusses the TFDA's organizational structure, administrative objectives, policies and regulations for managing food, medicinal products, medical devices and cosmetics. Key highlights include strengthening food safety laws, shortening drug review timelines, expanding medical device sales channels, increasing border inspections, and enhancing international cooperation. The TFDA aims to safeguard public health through a five-pronged strategy of ensuring a stable management system, controlling product imports and manufacturing, overseeing distribution, and protecting consumers.
Who good distributionpracticesforpharmaceuticalproductsadeelzia84
The document summarizes the history and contents of the WHO Good Distribution Practices for Pharmaceutical Products guidelines. It was originally adopted in 2005 and revised in 2009 to improve security against counterfeit medicines. The goals are to ensure quality and identity of pharmaceuticals during distribution. It defines distribution and outlines general principles like traceability and responsibilities across the supply chain. Key points covered include regulations, personnel training, documentation, repackaging, recalls, investigating counterfeits, and next steps to finalize the guidelines.
HACCP (Hazard Analysis Critical Control Point) is a food safety system that identifies potential food safety hazards and puts controls in place to prevent them. It was originally developed in the 1960s for NASA space missions to ensure food safety. Since then, HACCP principles have been adopted worldwide by food standards organizations and legislation. The document provides a detailed history of the development of HACCP from 1959 to the present and describes the seven principles of HACCP and guidelines for its application, which include assembling a HACCP team, describing products, identifying intended uses, constructing flow diagrams, identifying hazards and controls, determining critical control points, and establishing monitoring, verification and documentation procedures.
Internship report for pharmaceutical industryRai Waqas
Envoy Pharmaceutical is an ISO certified pharmaceutical company located in Lahore, Pakistan. The internship report summarizes the company's departments and manufacturing processes. Key departments include warehousing, production, and quality control. The production department manufactures tablets, capsules, oral liquids, and injectables using modern equipment according to cGMP standards. Raw materials are received and tested before use. Finished products are packaged and labeled for distribution. The report provides an overview of Envoy Pharmaceutical's operations during the author's internship.
The document discusses Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGMP). It defines GMP as ensuring products are consistently manufactured and controlled according to quality standards for their intended use. cGMP emphasizes that expectations are dynamic and evolve over time. The document outlines several key GMP considerations including organization and personnel qualifications, facility and equipment design, production and process control, packaging and labeling, handling and distribution, and documentation through records and reports.
Quality Perspective of ‘Good Distribution Practices’ in Indian Pharmaceutical...iosrjce
This document discusses quality issues that can arise during the distribution of pharmaceutical products in India. It notes that good distribution practices (GDP) are important to ensure quality from manufacturing to retailers. A survey of pharmaceutical professionals found the biggest concern was illegible product information on labels/packaging, which could result from issues like label scratching or ink smudging during distribution. Other potential quality defects discussed include product degradation from improper temperature control, contamination from seal breaks, and absorption of smells/tastes from shared cargo transit. The document emphasizes that distribution practices need to be carefully controlled and aligned with good manufacturing quality standards to avoid defects that could compromise patient health and safety.
This document provides an overview of ICH Q10, which describes a pharmaceutical quality system model based on ISO quality concepts and GMP regulations. The quality system can be implemented throughout a product's lifecycle to facilitate innovation, continual improvement, and strengthen the link between development and manufacturing. ICH Q10 augments GMPs by describing specific quality system elements and management responsibilities to achieve product realization, establish state of control, and facilitate continual improvement.
The document compares regulatory standards for Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). It finds that GMP places more emphasis on maintaining quality during product manufacturing, while GDP guidance for distribution is less extensive. Both are important quality systems, but GMP requirements for manufacturing processes are more rigorous. Pharmaceutical companies should design quality systems that ensure product quality is maintained during both manufacturing and distribution operations.
Pharmaceutical manufacturing has become a significant industry in India. It has been estimated that has the third largest pharmaceutical industry by volume We will examine how well they comply with Good Manufacturing Practices (GMP).
The International Council for Harmonisation (ICH) brings together regulatory authorities and the pharmaceutical industry to discuss technical requirements for drug registration. ICH has produced guidelines on quality, safety, efficacy, and multidisciplinary topics. The quality guidelines cover stability testing, analytical validation, impurities, Good Manufacturing Practice, and quality risk management. Together, the ICH guidelines aim to harmonize technical requirements across regions to provide efficient drug development and approval.
Losses due non-compliance with China food regulation and how to overcome Chi...Rong Liu
As the world’s largest imported food market, China imported totally 38 billion US dollars food products from187 countries in 2016.
The growing China market has attracted a lot of interest from different countries over the world. Meanwhile China government has, over the last years, developed a tougher and tougher food regulation regime to regulate the market and ensure food safety.
Due to various challenges (languages, resources, information accessibility etc.), foreign SMEs learned a lot lessons and experienced big losses due to non-compliance with Chinese regulations.
Actually majority of these losses due non-compliance can be easily prevented if SMEs have reliable regulatory information in hand.
As a leading Chinese food regulation consulting company, FoodMate developed “Compliance Excellence” information service product for foreign SMEs with target to minimize your losses due regulatory non-compliance by assessing reliable and tailor made regulatory information.
This document provides an overview of Hong Kong's food safety framework and incidents relating to food additives. It describes the organization of the Food and Environmental Hygiene Department and the Centre for Food Safety, which oversees food surveillance programs. The legal framework for regulating food additives is also outlined. Recent surveillance results from 2011-2013 found some meat, vegetable and fruit samples containing excessive levels of preservatives like sulphur dioxide. Case examples are also presented, such as the detection of sulphur dioxide in some meat intended for raw consumption. The overall compliance rate for food additive regulations has improved according to the trend data shown.
This document summarizes the key impacts of China's new Food Safety Law on infant formula, health foods, and special dietary foods. It discusses increased regulations for infant formula, including whole process quality control, product registration, and restrictions on sub-packaging and using the same formula for different brands. It also outlines the import process for infant formula and challenges import companies may face, such as ensuring formulas are registered and formulations comply with local policies.
The document outlines the key aspects of current good manufacturing practices (cGMPs) that pharmaceutical manufacturers must follow. cGMPs come from the Food, Drug and Cosmetic Act and are enforced by the FDA. They help ensure safety and quality by requiring strict control over facilities, equipment, components, packaging, labeling, and processes. Key parts of cGMP regulations address organization, buildings, equipment, materials control, production, packaging, holding, distribution, and records. Failure to comply can result in serious legal and business consequences like product recalls or plant shutdowns.
Food Safety, Hygiene and Food Quality AssuranceTUVSUDIndia
modern food safety and hygiene testing practices ensure that
the food products are contamination-free and act in accordance with national and international food
safety and hygiene standards. Known to be one of the most trusted names in the food safety and
hygiene industry, TÜV SÜD has been helping businesses with food safety and quality services including
testing, auditing, training, certification, and regulatory compliance. Find out more about our food safety
and hygiene management services here, https://www.tuvsud.com/en-in/industries/consumer-products-and-retail/food/food-training
The European Commission Health and Consumers Directorate – General has published draft “GUIDELINES ON THE FORMALISED RISK ASSESSMENT FOR ASCERTAINING THE APPROPRIATE GOOD MANUFACTURING PRACTICE FOR EXCIPIENTS OF MEDICINAL PRODUCTS FOR HUMAN USE” for public consultation.
Following presentation has been prepared by " Drug regulations" a not for profit organization which provides free online resources for the Pharmaceutical Professional.
Good Manufacture Practices Pharmaceutical technologyafsanamamedova
The document discusses Good Manufacturing Practices (GMP) which are a system for ensuring that products are consistently produced and controlled according to quality standards. It covers GMP guidelines from various organizations, key aspects of GMP like packaging and facilities, and concepts like quality assurance, quality control, documentation practices. GMP is important for minimizing risks in pharmaceutical production and ensuring medicine quality and safety. Adherence to GMP regulations is necessary for pharmaceutical manufacturers and exporters.
the all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
This document discusses Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGMP). It defines GMP as ensuring products are consistently manufactured and controlled to quality standards for their intended use. cGMP emphasizes that expectations are dynamic and current. Quality is defined as a product's fitness for purpose. GMP is designed to minimize risks that cannot be eliminated through testing, such as contamination or incorrect labeling. Adhering to GMP is important to ensure medicines contain the proper ingredients and doses. The document outlines key aspects of GMP, including facilities, equipment, documentation, validation, training, and audits.
201 regulatory aspects of drug and cosmetics .pdfBhavikaAPatel
regulatory aspects of drug and cosmetics
1. Regulatory Requirements for Registration of Drugs & Post Approval Requirements in WHO through Prequalification Program
2. FDA ORGANIZATION CHART
3. Marketing Authorization of EU for APPLICATION PROCEDURES
4. Global Countries Classification
5. Organization and structure of EMA&EDQMActive substance Master files IMPD
6. DRUG MASTER FILE in USA
The document summarizes the WHO Prequalification Programme, which aims to ensure that medicines and health products meet global standards of quality, safety and efficacy. The key points are:
1. The programme comprehensively evaluates products based on manufacturer submissions and site inspections to verify compliance with WHO standards. Products that meet standards are added to the WHO prequalified lists.
2. The programme was launched in 2001 to address quality issues with medicines for HIV/AIDS, malaria, and tuberculosis in developing countries. It has since expanded to other health products and diseases.
3. The prequalification process involves an expression of interest, dossier submission and evaluation, site inspections, listing of prequalified products, ongoing monitoring, and de
GMP and cGMP considerations ensure consistent manufacturing and quality control of pharmaceutical products. Key points:
1. GMP aims to minimize risks like contamination or incorrect dosing that cannot be eliminated through final testing.
2. QA, GMP and QC are interrelated but distinct - QA ensures overall quality, GMP covers all production aspects, and QC involves sampling, testing and release procedures.
3. Following GMP guidelines is important for safety, efficacy and export opportunities. GMP requires documented procedures covering all steps to build quality into every batch.
CGMP is current good manufacturing practices followed for achieving good quality product which is effective and safe for patients. USFDA's motto is to protect the health of patients along with biologicals.
EMEA is supposed to take care of medicines for human use as veterinary use.
CDER & CBER are the main branches of USFDA which gives guidelines for drug & biologics.
Introduction to quality assurance and qualtiy controlAmruta Balekundri
Quality assurance and quality control are important functions to ensure pharmaceutical products meet required standards of quality.
Quality assurance aims to prevent defects through establishing good manufacturing processes and quality systems, while quality control identifies defects by testing final products. Together they help fulfill quality requirements.
The history of quality evolution in pharmaceuticals shows how regulations were strengthened in response to safety issues. Milestones include the 1906 and 1938 acts in the US and 1978 GMP standards, aiming to ensure drug safety and efficacy. Quality assurance and quality control play key roles in implementing these standards and continually improving pharmaceutical quality.
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
The document discusses Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). It defines GLP as an FDA regulation that provides a framework for planning, performing, monitoring, reporting and archiving laboratory studies. GLP aims to ensure quality and correctness in laboratory results. Similarly, GMP is an FDA regulation that ensures quality and performance in manufacturing activities. The document traces the history of GLP and GMP, reasons for their creation, their objectives and key differences between the two.
This document provides an introduction to Good Manufacturing Practices (GMP). It defines GMP as a set of principles and procedures that help ensure therapeutic goods manufactured will have the required quality. GMP was first established in the US in 1963 to ensure drugs are consistently manufactured and controlled to quality standards for their intended use. The objectives of GMP are to produce products that conform to predetermined specifications, are of consistent quality, and minimize contamination and errors. Key aspects of GMP include having trained employees, documented processes, adherence to standard operating procedures, clean premises, and quality assurance testing of products before distribution.
GLP and GMP are quality systems concerned with organizing and documenting the testing and manufacturing of products like pharmaceuticals, pesticides, and chemicals.
GLP applies to nonclinical safety studies and helps ensure data submitted to regulators is valid. It originated in the 1970s in response to cases like Industrial Bio Test, which falsified lab results. GLP principles cover the organization, facilities, equipment, standard operating procedures, performance, reporting, and record keeping of studies.
GMP aims to consistently produce quality products by having quality control systems in place and following manufacturing procedures. It is designed to minimize risks that cannot be eliminated through testing. The ten GMP principles include facility design, written procedures, documentation, validation, monitoring
This document provides an overview of Good Manufacturing Practices (GMP) for pharmaceutical manufacturing. It defines GMP as ensuring products are consistently manufactured and controlled to quality standards for their intended use. The document outlines key aspects of GMP, including facilities and equipment qualification, training, documentation, production and process controls, packaging and labeling, quality testing, and distribution. It explains that GMP is important for producing safe, effective drugs and minimizing risks that cannot be detected through final testing alone. International GMP guidelines from organizations like WHO, FDA, and ICH are also referenced.
1. The document discusses key concepts in pharmaceutical quality including GMP, QA, QC, validation, and contamination control. It provides definitions and explanations of these terms.
2. GMP regulations require manufacturers to ensure product quality and safety. The document outlines 17 key parameters that pharmaceutical companies must follow under GMP.
3. Contamination can occur through particulates, chemicals, or microbes. The document describes major sources of each type of contamination and how they can be controlled.
The document discusses required Good Manufacturing Practice (GMP) standards and inspections. It notes that a drug firm is considered in a state of control when it can guarantee a finished drug's quality, strength and purity throughout production and compliance with its registration. Key elements of compliance include equipment, components, personnel, facilities, processes, qualification, analysis, training, product approval, self-inspection and monitoring. Recent trends in inspections include a focus on risk assessment and quality systems. Inspections are conducted for regular schedules, submissions, changes, recalls and past inspection history.
Good Manufacturing Practice (GMP) regulations ensure that pharmaceutical products are consistently produced and controlled according to quality standards. GMP has regulations for facilities, equipment, personnel, sanitation, testing of raw materials and finished products, manufacturing, packaging, quality control, records, and stability. Following GMP procedures guarantees high quality products for consumers by minimizing risks of contamination and ensuring correct labeling and potency. Key aspects of GMP include written procedures, process validation, environmental monitoring, and record keeping. Strict adherence to GMP is important for producing safe, effective medicines.
Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods.
This document provides guidance for creating an effective patch management program for industrial control systems. It recommends establishing several key plans: a configuration management plan to track systems and software; a patch management plan to evaluate vulnerabilities and deploy patches; a backup/archive plan to preserve system states; a patch testing plan to validate patches; an incident response plan to address vulnerabilities; and a disaster recovery plan in case patches fail. When these plans are integrated and their resources leveraged together, they provide a robust approach to patch management that balances security, reliability and operational needs.
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Facets Overview and Navigation User Guide.pdfwardell henley
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Best practices for_implementing_security_awareness_trainingwardell henley
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This document provides a checklist for securing a Splunk software installation, including setting up authenticated users and managing access, using certificates to encrypt communications, hardening Splunk instances, setting consistent passwords across servers, securing service accounts, auditing the system regularly to monitor access and activities, and monitoring files and directories.
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This document provides an overview of Enterprise Content Management (ECM) and discusses how ECM solutions can be supported by various storage technologies and solutions. It begins with introductions to ECM and storage concepts for specialists in the opposite fields. It then discusses business drivers for ECM and provides a reference architecture for matching ECM requirements to appropriate storage strategies. The reference architecture addresses requirements for security, integrity, retention, availability and cost, among others. It also covers storage considerations for availability, backup/recovery, business continuity and capacity planning.
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3) Avoid false positives from security tests to prevent blocking critical updates.
4) Build security expertise among developers by training them in secure coding practices.
5) Maintain visibility into application security for deployed software to enable quick responses to attacks.
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UiPath Test Automation using UiPath Test Suite series, part 6
9 150928065812-lva1-app6892 gmp
1. GOOD MANUFACTURING
PRACTICES FOR
PHARMACEUTICALS
2014/02/18 1
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
Dr. Basavaraj K. NanjwadeM. Pharm., Ph. D
Department of Pharmaceutics
Faculty of Pharmacy
Omer Al-Mukhtar University
Tobruk, Libya.
E-mail: nanjwadebk@gmail.com
2. CONTENTS
• Current GMP in manufacturing processes
• Packaging and holding of drugs
• Finished pharmaceuticals
• General provisions
• Organization and personnel
• Building and facilities
• Equipment
• Control of components
• Containers and closures
• Production and process control
• Packaging and labeling control
• Holding and distribution
• Records and reports
• Returned savaged drug products
• The inspection for compliance with GMP regulations
• Controlled substances safeguards
• References
2014/02/18 2
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
4. What is GMP ?(Good Manufacturing Practices)
• GMP is that part of Quality assurance which ensures
that the products are consistently manufactured and
controlled to the Quality standards appropriate to
their intended use
• A set of principles and procedures which, when
followed by manufacturers for therapeutic goods,
helps ensure that the products manufacture will have
the required quality.
2014/02/18 4
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
5. Good Manufacturing Practices
• A basic tenet of GMP is that quality cannot be
tested into a batch of product but must be built
into each batch of product during all stages of
the manufacturing process.
• It is designed to minimize the risks involved in
any pharmaceutical production that cannot be
eliminated through testing the final product.
2014/02/18 5
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
6. Some of the main risks are
– Unexpected contamination of products, causing
damage to health or even death.
– Incorrect labels on containers, which could mean
that patients receive the wrong medicine.
– Insufficient or too much active ingredient,
resulting in ineffective treatment or adverse
effects.
2014/02/18
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
6
7. Why GMP is important
• A poor quality medicine may contain toxic
substances that have been unintentionally added.
• A medicine that contains little or none of the
claimed ingredient will not have the intended
therapeutic effect.
2014/02/18
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
7
8. QC
GMP
QA
GMP
2014/02/18 8
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
QA: Quality Assurance
GMP: Good Manufacturing Practices
QC: Quality Control
9. QA, GMP & QC inter-relationship
It is the sum total of the
organized arrangements with
the objective of ensuring that
products will be of the quality
required for their intended use
QA
2014/02/18 9
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
10. GMP
Is that part of Quality Assurance
aimed at ensuring that products
are consistently manufactured to
a quality appropriate to their
intended use
GMP
2014/02/18 10
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
11. QA, GMP & QC inter-relationship
Is that part of GMP concerned with
sampling, specification & testing,
documentation & release procedures
which ensure that the necessary &
relevant tests are performed & the
product is released for use only after
ascertaining it’s quality
QC
2014/02/18 11
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
12. QC and QA
• QC is that part of GMP
which is concerned with
sampling, specifications,
testing and with in the
organization, documentation
and release procedures which
ensure that the necessary and
relevant tests are carried out
• QA is the sum total of
organized arrangements
made with the object of
ensuring that product
will be of the Quality
required by their
intended use.
2014/02/18 12
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
13. QC and QA
• Operational laboratory
techniques and activities
used to fulfill the
requirement of Quality
• All those planned or
systematic actions
necessary to provide
adequate confidence
that a product will
satisfy the requirements
for quality
2014/02/18 13
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
14. QC and QA
• QC is lab based • QA is company based
2014/02/18 14
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
15. GMP
• The Quality of a formulation or a bulk drug
depends on the Quality of those producing it
• GMP is the magic key that opens the door of
the Quality
• In matter of GMP, swim with the current and
in matter of Quality stand like a rock!
2014/02/18 15
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
16. GMP helps boost pharmaceutical
export opportunities
• Most countries will only accept import and
sale of medicines that have been manufactured
to internationally recognized GMP.
• Governments seeking to promote their
countries export of pharmaceuticals can do so
by making GMP mandatory for all
pharmaceutical production and by training
their inspectors in GMP requirements.
2014/02/18
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
16
17. GMP Covers…
• All aspects of production; from the starting materials,
premises and equipment to the training and personal
hygiene of staff.
• Detailed, written procedures are essential for each
process that could affect the quality of the finished
product.
• There must be systems to provide documented proof
that correct procedures are consistently followed at
each step in the manufacturing process - every time a
product is made.
2014/02/18
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
17
18. GMP guidelines
• GMP as per Schedule “M”
• GMP as per WHO
• GMP as per MCA now known as MHRA
• GMP as per TGA
• GMP as per US FDA
• GMP as per ICH guidelines
WHO: World Health Organization
MHRA: Ministry of Health and Regulatory Affairs
TGA: Therapeutic Goods Affairs
FDA: Food And Drug Administration
ICH: International Conference on Harmonization
2014/02/18 18
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
19. GMP guidelines
• GMP as per Schedule “M”
www.cdsco.nic.in
• GMP as per WHO
www.who.int
• GMP as per MCA now known as MHRA
www.mca.gov.uk
• GMP as per TGA
www.tga.gov.au
• GMP as per US FDA
www.fda.gov
• GMP as per ICH guidelines
www.ich.org
2014/02/18
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
19
20. GMP
• GMP in solid dosage forms
• GMP in semisolid dosage forms
• GMP in Liquid orals
• GMP in Parenterals Production
• GMP in Ayurvedic medicines
• GMP in Bio technological products
• GMP in Nutraceuticals and cosmeceuticals
2014/02/18 20
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
21. Ten Principles of GMP
1. Design and construct the facilities and equipments
properly
2. Follow written procedures and Instructions
3. Document work
4. Validate work
5. Monitor facilities and equipment
6. Write step by step operating procedures and work on
instructions
7. Design ,develop and demonstrate job competence
8. Protect against contamination
9. Control components and product related processes
10. Conduct planned and periodic audits
2014/02/18 21
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
22. List of important
documents in GMP
• Policies
• SOP (Standard Operating Procedure)
• Specifications
• MFR (Master Formula Record)
• BMR (Batch Manufacturing Record)
• Manuals
• Master plans/ files
• Validation protocols
• Forms and Formats
• Records
2014/02/18
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
22
23. 10 attributes of a good document
1. Accurate
2. Clear
3. Complete
4. Consistent
5. Indelible
6. Legible
7. Timely
8. Direct
9. Authentic
10. Authorized
2014/02/18
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
23
29. Current GMP in manufacturing
processes (cGMP)
2014/02/18 29
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
30. What are cGMPs?
• cGMP refers to the Current Good Manufacturing
Practice regulations enforced by the US Food and
Drug Administration (FDA).
• cGMP provide for systems that assure proper design,
monitoring and control of manufacturing processes
and facilities.
• Adherence to the cGMP regulations assures the
identity, strength, quality and purity of drug products
by requiring that manufacturers of medications
adequately control manufacturing operations
2014/02/18
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
30
31. Why are cGMP so important
• A consumer usually cannot detect (through smell,
touch, or sight) that a drug product is safe or if it will
work.
• While cGMPs require testing, testing alone is not
adequate to ensure quality.
• In most instances testing is done on a small sample of
a batch (for example, a drug manufacturer may test
1000 tablets from a batch that contains 2 million
tablets), so that most of the batch can be used for
patients rather than destroyed by testing.
2014/02/18
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
31
35. Packaging and holding of
drugs
• Care shall be taken when using automatic
tablet and capsule counting, strip and blister
packaging equipment to ensure that all ‘rogue’
tablets, capsules or foils from packaging
operation are removed before a new packaging
operation is commenced.
• There shall be an independent recorded check
of the equipment before a new batch of tablets
or capsules is handled.
2014/02/18 35
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
36. Finished pharmaceuticals
Appropriate specifications for finished products
shall include: -
• The designated name of the product and the code
reference.
• The formula or a reference to the formula and the
pharmacopoeial reference.
• Directions for sampling and testing or a reference
to procedures.
2014/02/18 36
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
37. General provisions
• The processing of dry materials and products
creates problems of dust control and cross-
contamination. Special attention is therefore,
needed in the design, maintenance and use of
premises and equipment in order to overcome
these problems. Wherever required, enclosed
dust control manufacturing systems shall be
employed.
2014/02/18 37
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
38. Organization and personnel
1. Responsibilities of quality control unit.
2. Personnel qualifications.
3. Personnel responsibilities.
4. Consultants.
2014/02/18
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
38
39. Building and facilities
1. Design and construction features.
2. Lighting.
3. Ventilation, air filtration, air heating and
cooling.
4. Plumbing.
5. Sewage and refuse.
6. Washing and toilet facilities.
7. Sanitation.
8. Maintenance.
2014/02/18
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
39
40. Equipment
1. Equipment design, size, and location.
2. Equipment construction.
3. Equipment cleaning and maintenance.
4. Automatic, mechanical, and electronic
equipment.
5. Filters.
2014/02/18
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
40
41. Control of components
1. General requirements.
2. Receipt & storage of untested components, drug
product containers and closures.
3. Testing and approval or rejection of components,
drug product containers and closures.
4. Use of approved components, drug product
containers, and closures.
5. Retesting of approved components, drug product
containers, and closures.
6. Rejected components, drug product containers, and
closures.
7. Drug product containers and closures.
2014/02/18
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
41
42. Containers and closures
• All containers and closures intended for use shall
comply with the pharmacopoeial requirements.
Suitable validated test methods, sample sizes,
specifications, cleaning procedure and
sterilization procedure, wherever indicated, shall
be strictly followed to ensure that these are not
reactive, additive, absorptive, or leach to an extent
that significantly affects the quality or purity of
the drug. No second hand or used containers and
closures shall be used.
2014/02/18 42
Faculty of Pharmacy, Omar Al-Mukhtar University,
Tobruk, Libya.
43. Production and process
control
1. Written procedures; deviations.
2. Charge-in of components.
3. Calculation of yield.
4. Equipment identification.
5. Sampling and testing of in-process materials
and drug products.
6. Time limitations on production.
7. Control of microbiological contamination.
8. Reprocessing.
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44. Packaging and labeling
control
1. Materials examination and usage criteria.
2. Labeling issuance.
3. Packaging and labeling operations.
4. Tamper-evident packaging requirements for
over-the-counter (OTC) human drug
products.
5. Drug product inspection.
6. Expiration dating.
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46. Holding and distribution
1. Warehousing procedures.
2. Distribution procedures.
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47. Holding and distribution
• Prior to distribution or dispatch of given batch of a drug, it
shall be ensure that the batch has been duly tested, approved
and released by the quality control personnel. Pre-dispatch
inspection shall be performed on each consignment on a
random basis to ensure that only the correct goods are
dispatched. Detailed instructions for warehousing and stocking
of Large Volume Parenterals, if stocked, shall be in existence
and shall be complied with after the batch is released for
distribution. Periodic audits of warehousing practices followed
at distribution centers shall be carried out and records thereof
shall be maintained. Standard Operating Procedures shall be
developed for warehousing of products.
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49. Records and reports
1. General requirements.
2. Equipment cleaning and use log.
3. Component, drug product container, closure, and
labeling records.
4. Master production and control records.
5. Batch production and control records.
6. Production record review.
7. Laboratory records.
8. Distribution records.
9. Complaint files.
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50. Returned savaged drug
products
1. Returned drug products.
2. Drug product salvaging.
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51. Returned savaged drug
products
• Adequate areas shall be designed to allow
sufficient and orderly warehousing of returned
or recalled products.
• Segregation shall be provided for the storage
of rejected, recalled or returned materials or
products.
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52. The inspection for compliance
with GMP regulations
• Short description of the self inspection system
indicating whether an outside, independent
and experienced external export was involved
in evaluating the manufacturer’s compliance
with Good manufacturing Practices in all
aspects of production.
• Periodic inspection of the garments shall be
done by responsible staff.
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53. Controlled substances
safeguards
• Hazardous, toxic substances and flammable materials
shall be stored in suitably designed and segregated,
enclosed areas in conformity with Central and State
Legislations.
• Highly hazardous, poisonous and explosive materials
such as narcotics, psychotropic drugs and substances
presenting potential risks of abuse, fire or explosion
shall be stored in safe and secure areas. Adequate fire
protection measures shall be provided in conformity
with the rules of the concerned civic authority.
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54. References
• EU Good Manufacturing Practice (GMP)
Guidelines, Volume 4 of “The rules governing
medicinal products in the European Union”
• US FDA current Good Manufacturing
Practice (cGMP) for finished
pharmaceuticals, 21 CFR, 210 and 211
• WHO Good Manufacturing Practices for
pharmaceutical products, Annex 4 to WHO
Technical Report Series, No. 908, 2003
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Tobruk, Libya.