The document discusses regulations governing Good Manufacturing Practices (GMP). It aims to provide an understanding of GMP regulations and their application and interpretation. The key GMP regulations cover the drug, medical device, food, and blood industries. GMP regulations provide flexibility for manufacturers but can also lead to confusion in interpretation. Subparts cover organization and personnel qualifications, facilities and equipment requirements, material and component controls, production and process controls, and documentation.
This document provides an introduction to auditing and the audit process. It defines an audit as the on-site verification of a process or quality system to ensure compliance. Audits can be conducted internally or externally according to ICH guidelines. The objectives of an audit are to determine conformity or nonconformity with quality systems and to improve quality. Pharmaceutical manufacturers use GMP audits to verify manufacturing controls and permit timely problem correction. Management audits comprehensively examine an organization. Audits can be first, second, or third party. An auditor's responsibilities include providing audit reports and identifying issues. The planning process for an audit involves announcing a schedule, conducting meetings, performing the audit, and providing follow-up.
This document provides an overview of current good manufacturing practice (cGMP) guidelines for active pharmaceutical ingredients (APIs) according to the US Food and Drug Administration (FDA). It discusses cGMP requirements for personnel responsibilities and training, facility design and maintenance, process utilities, containment practices, documentation and record keeping, and control of contamination during API manufacturing. The document is intended to provide guidance on complying with cGMP standards to ensure the quality of APIs.
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical industry to describe standards by which documents are created and maintained. While some GDocP standards are codified by various competent authorities, others are not but are considered cGMP (with emphasis on the "c", or "current"). Some competent authorities release or adopt guidelines, and they may include non-codified GDocP expectations. While authorities will inspect against these guidelines and cGMP expectations in addition to the legal requirements and make comments or observations if departures are seen. In the past years, the application of GDocP is also expanding to cosmetic industry, excipient and ingredient manufacturers.
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
The document discusses the requirements and procedures for conducting an Annual Product Quality Review (APQR). Key points include:
- The APQR is intended to verify process consistency, assess trends, determine needed specification/procedure changes, and evaluate revalidation needs.
- Regulatory guidelines like ICH Q7, FDA, and EU require annual reviews that include batch data, deviations, complaints, stability results, and corrective actions.
- The quality unit coordinates the APQR using data and participation from other departments. The review is documented and approved by senior quality management.
I am uploading this GMP presentation to make aware who are working in pharma and help to maintain high standards in products manufacturing .
GMP Vs cGMP: It is my understanding that , Ultimately GMP & cGMP both the aim is same, means to prevention of the product from bad quality entering the market to endover peoples's life.
GMP applies to pharmaceutical and healthcare products and help to maintain high standards in these products.
cGMP is to remind accepting countries that all guidelines must be followed with latest and current production processes i.e employ technologies and systems which are up-to-date in order to comply with the regulation.
FDA (Food and Drug Administration) included the word “current” to ensure that regulated firms use the most current Good Manufacturing Practices (I believe that some firms would actually use outdated versions of the GMP’s to manufacture regulated products.
(the FDA have made their standards immediately identifiable i.e cGMP; Other international bodies such as the ICH, WHO use the term GMP, as do Canada, Japan and the EMEA (European authority). In FDA view cGMP means following 21 CFR 210 and 211 and no other.)
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
The document discusses the Current Good Manufacturing Practices (CGMP) regulations as defined by the United States Food and Drug Administration (USFDA). It provides an overview of the various centers within USFDA including the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) that are responsible for regulating drugs and biologics respectively. It also summarizes the key CGMP principles, documentation requirements, and the various subparts outlined in the regulations including facilities, equipment, production controls, packaging and labeling, and record keeping.
This document provides an introduction to auditing and the audit process. It defines an audit as the on-site verification of a process or quality system to ensure compliance. Audits can be conducted internally or externally according to ICH guidelines. The objectives of an audit are to determine conformity or nonconformity with quality systems and to improve quality. Pharmaceutical manufacturers use GMP audits to verify manufacturing controls and permit timely problem correction. Management audits comprehensively examine an organization. Audits can be first, second, or third party. An auditor's responsibilities include providing audit reports and identifying issues. The planning process for an audit involves announcing a schedule, conducting meetings, performing the audit, and providing follow-up.
This document provides an overview of current good manufacturing practice (cGMP) guidelines for active pharmaceutical ingredients (APIs) according to the US Food and Drug Administration (FDA). It discusses cGMP requirements for personnel responsibilities and training, facility design and maintenance, process utilities, containment practices, documentation and record keeping, and control of contamination during API manufacturing. The document is intended to provide guidance on complying with cGMP standards to ensure the quality of APIs.
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical industry to describe standards by which documents are created and maintained. While some GDocP standards are codified by various competent authorities, others are not but are considered cGMP (with emphasis on the "c", or "current"). Some competent authorities release or adopt guidelines, and they may include non-codified GDocP expectations. While authorities will inspect against these guidelines and cGMP expectations in addition to the legal requirements and make comments or observations if departures are seen. In the past years, the application of GDocP is also expanding to cosmetic industry, excipient and ingredient manufacturers.
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
The document discusses the requirements and procedures for conducting an Annual Product Quality Review (APQR). Key points include:
- The APQR is intended to verify process consistency, assess trends, determine needed specification/procedure changes, and evaluate revalidation needs.
- Regulatory guidelines like ICH Q7, FDA, and EU require annual reviews that include batch data, deviations, complaints, stability results, and corrective actions.
- The quality unit coordinates the APQR using data and participation from other departments. The review is documented and approved by senior quality management.
I am uploading this GMP presentation to make aware who are working in pharma and help to maintain high standards in products manufacturing .
GMP Vs cGMP: It is my understanding that , Ultimately GMP & cGMP both the aim is same, means to prevention of the product from bad quality entering the market to endover peoples's life.
GMP applies to pharmaceutical and healthcare products and help to maintain high standards in these products.
cGMP is to remind accepting countries that all guidelines must be followed with latest and current production processes i.e employ technologies and systems which are up-to-date in order to comply with the regulation.
FDA (Food and Drug Administration) included the word “current” to ensure that regulated firms use the most current Good Manufacturing Practices (I believe that some firms would actually use outdated versions of the GMP’s to manufacture regulated products.
(the FDA have made their standards immediately identifiable i.e cGMP; Other international bodies such as the ICH, WHO use the term GMP, as do Canada, Japan and the EMEA (European authority). In FDA view cGMP means following 21 CFR 210 and 211 and no other.)
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
The document discusses the Current Good Manufacturing Practices (CGMP) regulations as defined by the United States Food and Drug Administration (USFDA). It provides an overview of the various centers within USFDA including the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) that are responsible for regulating drugs and biologics respectively. It also summarizes the key CGMP principles, documentation requirements, and the various subparts outlined in the regulations including facilities, equipment, production controls, packaging and labeling, and record keeping.
This document provides an overview of air handling systems (AHUs) and HVAC qualification for pharmaceutical facilities. It contains sections on introduction, types of clean rooms, principles of clean rooms, HVAC components, regulatory requirements, contamination control, air flow patterns, and HVAC qualification steps including user requirement specification, design qualification, and installation qualification. The objective is to understand the need for pharmaceutical air handling systems and their technical and qualification requirements.
User specification requirements (urs) rashRASHMINasare
user specification requirements, factory acceptance test, & design qualification is the part of validation it is doing because the satisfaction of the customer & full filled the user requirement
This document discusses good documentation practices (GDP) in the pharmaceutical industry. GDP describes standards for creating and maintaining documentation to ensure regulatory compliance, customer requirements are met, and documentation errors do not cause safety, legal or regulatory issues. Proper GDP is important as documentation serves as an advertisement of how committed and sincere a company is. GDP covers documentation for various organizational functions and requires documentation be permanent, legible, accurate, prompt, clear, consistent, complete, direct, truthful, current and traceable. The document outlines specific standards and steps for GDP including proper recording, corrections, signatures and reviews.
1. In-process quality control (IPQC) involves monitoring and adjusting manufacturing processes to ensure products meet specifications from raw materials to finished products.
2. IPQC includes tests and inspections of materials, equipment, processes, and operations during production to check for accuracy, uniformity, and consistency within and between batches.
3. Common in-process controls for pharmaceuticals involve testing attributes like weight, content of active ingredients, disintegration, and checking for contamination.
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.
Product development and technology transfer M pharmPoojaWadgave
1. The document discusses technology transfer in the pharmaceutical industry, which refers to transferring details about formulations and analytical methods from research and development to production. This includes transferring a drug product from laboratory scale to production scale.
2. It outlines the goals, objectives, methods, and importance of technology transfer. The key methods are licensing and technology transfer involves a framework including a feasibility study, scale-up, validation, and production batches.
3. Successful technology transfer requires establishing a technology transfer team representing different areas like quality assurance, production, and engineering to review documentation, manufacturing processes, and equipment needs.
I. This document outlines the key aspects of Good Manufacturing Practices (GMP) and cGMP, including a timeline of GMP development, requirements for personnel, premises, equipment, standard operating procedures, validation processes, and documentation such as batch records.
II. It defines GMP as ensuring consistent and controlled production of products according to quality standards. cGMP requirements include qualified personnel, designed facilities and equipment, and documented procedures for manufacturing, testing, and record keeping.
III. The document provides details on specific GMP rules for premises, equipment, personnel, operations, warehousing, validation, and labeling. Adherence to GMP aims to minimize errors and ensure uniform, high quality batches of pharmaceutical products.
The document discusses the qualification of analytical equipment like electronic balances and pH meters. It explains that qualification includes design, installation, operational and performance qualification to ensure equipment is properly installed and functioning accurately. Specific steps for qualifying balances, such as daily calibration checks with internal weights and yearly checks with external weights, are provided. The two-point calibration method for pH meters using buffer solutions is also described. Acceptance limits and record keeping procedures are outlined to ensure equipment remains calibrated over time.
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
This document discusses manufacturing operations and controls to prevent mix-ups and cross contamination. It outlines precautions like proper air handling, segregated areas, and status labeling. Processing of intermediates and bulk products must be documented and checks put in place to ensure quality like verifying identity and yields. Calibration records and batch production and control records are required. Contamination can occur from materials, areas, equipment or people so trained personnel and technical measures like separate production areas are important controls.
This document discusses deviation handling and root cause analysis. It defines deviations as departures from standard procedures and outlines regulatory expectations to investigate deviations and prevent reoccurrence. The basic process flow for handling deviations includes identification, assessment, classification, investigation and corrective actions. Root cause analysis is presented as a method to systematically identify underlying causes of problems using techniques like brainstorming, 5 whys, and cause-and-effect diagrams. The goals of root cause analysis are failure identification, analysis, and resolution through an iterative process.
In Pharma and Biotech, Weightage of the Documentation is around 70 % because as per FDA "If you do not have Document, You dint have do it."
So Good Documentation Practice is of tremendous importance for the Industry to comply any regulation like FDA, GMP or ISO.
The document discusses the analysis of raw materials used in pharmaceutical manufacturing, noting that raw materials must be tested to ensure suitability, identity, purity and quality through various analytical techniques as outlined in pharmacopeial monographs, and that quality assurance procedures like instrument validation and deviation management are critical factors for raw materials laboratories.
ANALYSIS OF RAW MATERIALS, FINISHED PRODUCTS, PACKAGING MATERIALS, IPQC, CPCS...Khadeeja6
RAW MATERIALS
It is basically the chemical ingredients of a process. starting material, in production of final product.
FINISHED PRODUCTS
Marketable product, transportable pack, salable pack
PACKAGING MATERIAL
Providing presentation, protection, identification, information, containment, convenience compliance, integrity and stability for a product during storage, transportation display and until it is consumed or throughout its shelf life.
IPQC
Providing accurate, specific and definite description of the procedures to be employed from the receipt of raw materials to the release of the finished dosage form.
CPCSEA GUIDELINES
Role of CPCSEA is to monitor animal experiments through ethics committees set up in institutions (IAEC)
CPCSEA Nominee -important link between CPCSEA and IAEC
IAEC scrutinize all project proposals for experimentation on animals.
The validity of IAEC is for 3 years.
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized.
This document discusses various quality control and documentation procedures in the pharmaceutical industry. It includes 3 key points:
1. It discusses the importance of documentation in defining specifications, methods, providing an audit trail and ensuring authorized personnel have necessary information. This includes documents like specifications, batch production records, SOPs etc.
2. It describes procedures for developing key documents like master formulas, batch manufacturing records, audit plans and reports. This ensures uniform processes and allows tracing of batch history.
3. It discusses quality audits which systematically examine if quality activities comply with arrangements and objectives. This includes internal audits as well as those imposed by regulators or customers.
Water system validation by- Akshay kakdeAkshay Kakde
This presentation discusses the validation of water systems used in pharmaceutical manufacturing. It covers the need for high quality water and purification systems, as well as the various qualification activities involved in validating such systems, including design qualification, installation qualification, operational qualification, and performance qualification. The presentation provides details on regulatory requirements and specifications for purified water and water for injection. It emphasizes that validation is necessary to ensure water systems consistently produce water meeting quality standards to avoid contamination of pharmaceutical products.
This document outlines good manufacturing practices and requirements for pharmaceutical manufacturing facilities. It discusses requirements for premises, buildings, warehousing, production, quality control, personnel, and operations. Specifically, it addresses the following key points:
1. Facilities must be designed and maintained to ensure hygienic manufacturing conditions and prevent contamination.
2. Separate dedicated areas are required for sensitive products like antibiotics and hazardous materials.
3. Production, quality control, and ancillary areas like personnel facilities must be separated.
4. Strict personnel hygiene practices and medical monitoring are required.
5. Manufacturing operations must be well-controlled and supervised to prevent mix-ups or
This document provides an overview of air handling systems (AHUs) and HVAC qualification for pharmaceutical facilities. It contains sections on introduction, types of clean rooms, principles of clean rooms, HVAC components, regulatory requirements, contamination control, air flow patterns, and HVAC qualification steps including user requirement specification, design qualification, and installation qualification. The objective is to understand the need for pharmaceutical air handling systems and their technical and qualification requirements.
User specification requirements (urs) rashRASHMINasare
user specification requirements, factory acceptance test, & design qualification is the part of validation it is doing because the satisfaction of the customer & full filled the user requirement
This document discusses good documentation practices (GDP) in the pharmaceutical industry. GDP describes standards for creating and maintaining documentation to ensure regulatory compliance, customer requirements are met, and documentation errors do not cause safety, legal or regulatory issues. Proper GDP is important as documentation serves as an advertisement of how committed and sincere a company is. GDP covers documentation for various organizational functions and requires documentation be permanent, legible, accurate, prompt, clear, consistent, complete, direct, truthful, current and traceable. The document outlines specific standards and steps for GDP including proper recording, corrections, signatures and reviews.
1. In-process quality control (IPQC) involves monitoring and adjusting manufacturing processes to ensure products meet specifications from raw materials to finished products.
2. IPQC includes tests and inspections of materials, equipment, processes, and operations during production to check for accuracy, uniformity, and consistency within and between batches.
3. Common in-process controls for pharmaceuticals involve testing attributes like weight, content of active ingredients, disintegration, and checking for contamination.
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.
Product development and technology transfer M pharmPoojaWadgave
1. The document discusses technology transfer in the pharmaceutical industry, which refers to transferring details about formulations and analytical methods from research and development to production. This includes transferring a drug product from laboratory scale to production scale.
2. It outlines the goals, objectives, methods, and importance of technology transfer. The key methods are licensing and technology transfer involves a framework including a feasibility study, scale-up, validation, and production batches.
3. Successful technology transfer requires establishing a technology transfer team representing different areas like quality assurance, production, and engineering to review documentation, manufacturing processes, and equipment needs.
I. This document outlines the key aspects of Good Manufacturing Practices (GMP) and cGMP, including a timeline of GMP development, requirements for personnel, premises, equipment, standard operating procedures, validation processes, and documentation such as batch records.
II. It defines GMP as ensuring consistent and controlled production of products according to quality standards. cGMP requirements include qualified personnel, designed facilities and equipment, and documented procedures for manufacturing, testing, and record keeping.
III. The document provides details on specific GMP rules for premises, equipment, personnel, operations, warehousing, validation, and labeling. Adherence to GMP aims to minimize errors and ensure uniform, high quality batches of pharmaceutical products.
The document discusses the qualification of analytical equipment like electronic balances and pH meters. It explains that qualification includes design, installation, operational and performance qualification to ensure equipment is properly installed and functioning accurately. Specific steps for qualifying balances, such as daily calibration checks with internal weights and yearly checks with external weights, are provided. The two-point calibration method for pH meters using buffer solutions is also described. Acceptance limits and record keeping procedures are outlined to ensure equipment remains calibrated over time.
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
This document discusses manufacturing operations and controls to prevent mix-ups and cross contamination. It outlines precautions like proper air handling, segregated areas, and status labeling. Processing of intermediates and bulk products must be documented and checks put in place to ensure quality like verifying identity and yields. Calibration records and batch production and control records are required. Contamination can occur from materials, areas, equipment or people so trained personnel and technical measures like separate production areas are important controls.
This document discusses deviation handling and root cause analysis. It defines deviations as departures from standard procedures and outlines regulatory expectations to investigate deviations and prevent reoccurrence. The basic process flow for handling deviations includes identification, assessment, classification, investigation and corrective actions. Root cause analysis is presented as a method to systematically identify underlying causes of problems using techniques like brainstorming, 5 whys, and cause-and-effect diagrams. The goals of root cause analysis are failure identification, analysis, and resolution through an iterative process.
In Pharma and Biotech, Weightage of the Documentation is around 70 % because as per FDA "If you do not have Document, You dint have do it."
So Good Documentation Practice is of tremendous importance for the Industry to comply any regulation like FDA, GMP or ISO.
The document discusses the analysis of raw materials used in pharmaceutical manufacturing, noting that raw materials must be tested to ensure suitability, identity, purity and quality through various analytical techniques as outlined in pharmacopeial monographs, and that quality assurance procedures like instrument validation and deviation management are critical factors for raw materials laboratories.
ANALYSIS OF RAW MATERIALS, FINISHED PRODUCTS, PACKAGING MATERIALS, IPQC, CPCS...Khadeeja6
RAW MATERIALS
It is basically the chemical ingredients of a process. starting material, in production of final product.
FINISHED PRODUCTS
Marketable product, transportable pack, salable pack
PACKAGING MATERIAL
Providing presentation, protection, identification, information, containment, convenience compliance, integrity and stability for a product during storage, transportation display and until it is consumed or throughout its shelf life.
IPQC
Providing accurate, specific and definite description of the procedures to be employed from the receipt of raw materials to the release of the finished dosage form.
CPCSEA GUIDELINES
Role of CPCSEA is to monitor animal experiments through ethics committees set up in institutions (IAEC)
CPCSEA Nominee -important link between CPCSEA and IAEC
IAEC scrutinize all project proposals for experimentation on animals.
The validity of IAEC is for 3 years.
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized.
This document discusses various quality control and documentation procedures in the pharmaceutical industry. It includes 3 key points:
1. It discusses the importance of documentation in defining specifications, methods, providing an audit trail and ensuring authorized personnel have necessary information. This includes documents like specifications, batch production records, SOPs etc.
2. It describes procedures for developing key documents like master formulas, batch manufacturing records, audit plans and reports. This ensures uniform processes and allows tracing of batch history.
3. It discusses quality audits which systematically examine if quality activities comply with arrangements and objectives. This includes internal audits as well as those imposed by regulators or customers.
Water system validation by- Akshay kakdeAkshay Kakde
This presentation discusses the validation of water systems used in pharmaceutical manufacturing. It covers the need for high quality water and purification systems, as well as the various qualification activities involved in validating such systems, including design qualification, installation qualification, operational qualification, and performance qualification. The presentation provides details on regulatory requirements and specifications for purified water and water for injection. It emphasizes that validation is necessary to ensure water systems consistently produce water meeting quality standards to avoid contamination of pharmaceutical products.
This document outlines good manufacturing practices and requirements for pharmaceutical manufacturing facilities. It discusses requirements for premises, buildings, warehousing, production, quality control, personnel, and operations. Specifically, it addresses the following key points:
1. Facilities must be designed and maintained to ensure hygienic manufacturing conditions and prevent contamination.
2. Separate dedicated areas are required for sensitive products like antibiotics and hazardous materials.
3. Production, quality control, and ancillary areas like personnel facilities must be separated.
4. Strict personnel hygiene practices and medical monitoring are required.
5. Manufacturing operations must be well-controlled and supervised to prevent mix-ups or
This presentation provides an overview of the history of drug regulations and Good Manufacturing Practices (GMPs) in the United States. It describes how regulations have evolved over time in response to safety issues and tragedies, from the early 1900s to present day, with the goal of ensuring drug products are safe and effective. Key events and acts that shaped regulations are highlighted, including the Federal Food, Drug, and Cosmetic Act of 1938 and amendments requiring proof of efficacy and safety testing.
This document discusses Schedule M, which outlines Good Manufacturing Practices (GMP) for pharmaceutical manufacturing in India. Schedule M was first implemented in 1988 and further amended in 2001. It describes requirements for factory premises, plants, and equipment for manufacturing drugs, pharmaceuticals, homeopathic preparations, cosmetics, and medical devices. The document outlines specific GMP requirements for sterile products, oral solid dosages, oral liquids, topical products, metered dose inhalers, and active pharmaceutical ingredients. It also references additional sources that provide more information on intellectual property rights and drug regulatory affairs in relation to Schedule M.
This document provides an overview of Schedule M, which outlines Good Manufacturing Practices (GMP) regulations in India for pharmaceutical manufacturing. It discusses the requirements for facilities, equipment, documentation, quality control, personnel, packaging and labeling. The key points covered include specifications for premises and equipment location, water systems, waste disposal, storage areas, production facilities, sanitation procedures, raw material control, calibration of instruments, documentation of records, self-inspection practices, quality control testing, batch processing, packaging and labeling, validation, recalls and adverse event reporting. The goal of Schedule M is to ensure consistent production and quality control of pharmaceuticals manufactured in India.
This document discusses Good Manufacturing Practice (GMP) in the pharmaceutical industry. It provides the history and regulations around GMP, explains why following GMP is important, and outlines the key elements that make up a GMP system.
GMP guidelines were established in the 1960s after thousands of babies were born with birth defects due to the drug Thalidomide. Regulations were put in place to ensure drug safety and quality. Following GMP helps build quality into manufacturing processes and products to avoid mistakes that could harm patients. Key aspects of GMP include controlling quality, using well-trained staff, thorough documentation, and adequate premises and equipment. The overall goal is to establish a system that consistently produces high quality pharmaceutical products.
This document provides an overview of good manufacturing practices (GMP) in the pharmaceutical industry. It begins with definitions of GMP and discusses its early history starting in the 1900s with no regulations. Key events that led to increased regulation include Upton Sinclair's 1905 book The Jungle exposing unsanitary meat plants and the 1906 Pure Food and Drug Act. The document then outlines the timeline of major GMP regulations from 1902 to the present. It provides details on key areas covered by GMP including personnel, premises, equipment, process validation, and quality assurance.
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.
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 document discusses current Good Manufacturing Practices (cGMP) according to the US Food and Drug Administration (FDA). It provides an overview of cGMP principles and requirements, including proper facilities and equipment design, documentation practices, and quality control. The document also summarizes key cGMP regulations and guidelines for manufacturing, processing, packaging, holding, testing, and distributing drug products. It outlines the important documents, facilities, equipment, production processes, and quality systems that must be in place to ensure consistent production of safe, effective pharmaceuticals.
This document provides an overview and summary of current good manufacturing practices (cGMP) regulations as enforced by the FDA in the US. It discusses the contents and subparts of Part 211, which provides the framework for cGMP. Key points covered include principles of cGMP regarding quality management and personnel qualifications. Building and facility requirements, equipment specifications, production and process controls, packaging and labeling, and quality control laboratory functions are also summarized. The document aims to familiarize the audience with cGMP regulations and quality system requirements for pharmaceutical manufacturing.
c gmp (current good manufacturing practices)Rohit K.
cGMP (Current Good Manufacturing Practices) regulations provide the framework for ensuring quality control during pharmaceutical manufacturing. The regulations are divided into parts 210 and 211. Part 211 addresses good manufacturing practices for finished pharmaceuticals and is further divided into 11 subparts covering organization, facilities, equipment, production, packaging, labeling, quality control, and more. The goal of cGMP is to ensure identity, strength, quality and purity of drugs through strict control of manufacturing and monitoring.
Principles of GMP Training Module ProgramLucky Saggi
Good manufacturing practices (GMP) are regulations and guidelines for ensuring that products are consistently produced and controlled according to quality standards. GMP covers all aspects of production from facilities and equipment to processes and quality control. Following GMP procedures is important for guaranteeing high quality, safe products and compliance with regulations. Regular audits help ensure ongoing adherence to GMP standards.
GMP Requirements & Drug & Cosmetic Act Provision.pptxEasy Concept
Good Manufacturing Practices (GMP) is that part of quality assurance, which ensures that products are regularly produced and controlled according to the quality standards suitable for their use.
(GMP) comes in Schedule M in D & C Act 1940 and Rules 1945.
GMPs are the requirements that the drug and methods/control /facilities used in their manufacturing, processing and packaging conforms to practice that will assure the safety and efficacy of the product.
Current Good Manufacturing Practices (cgmp)surajkumar1499
The document discusses cGMP (current Good Manufacturing Practices) according to the US FDA. It states that cGMP ensures quality is built into the manufacturing process from start to finish in order to minimize risks and protect product quality. It covers all aspects of manufacturing including facilities & equipment, documentation, personnel training, production & process controls, packaging & labeling, laboratory testing, and distribution. The key goal of cGMP is to assure the identity, strength, purity and quality of drugs. Compliance is required by the FDA regulations under 21 CFR Parts 210, 211, 820 etc.
The document provides an overview and summary of 21 CFR Part 211, which establishes the current good manufacturing practice (cGMP) regulations for finished pharmaceuticals enforced by the US Food and Drug Administration (FDA). It discusses the key subparts and sections of 21 CFR Part 211, including organization and personnel, facilities, equipment, production and process controls, and laboratory controls. The presentation aims to explain the cGMP regulations and quality standards that pharmaceutical manufacturers must comply with to ensure the safety, efficacy and purity of pharmaceutical products.
GMP regulations provide minimum standards for pharmaceutical manufacturing to ensure consistent high quality, safety, and efficacy of medicines. Key aspects of GMP include having documented procedures, validated processes, qualified facilities and equipment, trained personnel, cleaning and maintenance programs, quality control testing, and compliance auditing. Following GMP helps manufacturers produce pharmaceuticals that meet marketing authorizations and protects public health.
The document discusses objectives and policies of CGMP (current good manufacturing practices) and inventory management control. It provides 11 sections that outline CGMP policies related to personnel, premises, equipment, sanitation, storage, production, packaging, quality control, documentation, self-inspection, and product complaints. It also discusses the objectives of inventory control to minimize costs and disruption while ensuring adequate stock. Various techniques for inventory control are analyzed including ABC, VED, XYZ and SOS analyses.
The document discusses current good manufacturing practices (cGMP) which are regulations for pharmaceutical manufacturers to ensure quality products. It covers several key points:
cGMP aim to ensure quality control throughout the manufacturing process from facilities and equipment to production, testing and documentation. Strict adherence to cGMP is important because testing alone cannot guarantee quality and consumers rely on manufacturers to consistently produce safe, effective drugs. The document outlines various cGMP requirements for organization and responsibilities, building facilities, equipment cleaning and maintenance, validation processes, standard operating procedures, and the overall objectives of producing products that meet specifications and quality standards.
GMP regulations are designed to minimize risks in pharmaceutical production. They provide a framework to assure safety, identity, strength, quality and potency of drug products. GMPs require controlled production and adherence to regulations under the Federal Food, Drug and Cosmetic Act. The US GMP regulations are divided into parts 210 and 211, addressing building and facilities, equipment, packaging, labeling, holding, returns, and more. GMPs help ensure drug products are manufactured and controlled using quality standards appropriate for their intended use and to prevent adulteration.
This seminar basically explains about GMP and cGMP. It explains about thecode of federal regulation (CFR). After studying this seminar, the reader will get a detail knowldege pf what is GMP, cGMp, objectives and policies of cGMP. all the part of CFR part 21 is discussed in detail. Here in this seminar, main focus is given on the layout of the buildings and the equipment and its maintenant part. Layout of building includes the building design, construction of building and the plans. The life stage of equipments, how tp select a equipment befor epurchase i.e purchase specifications and the cleaninga nd the maintenance part of the equipments with examples are discussed in detail.
This document discusses Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGMP). It provides definitions of GMP and cGMP, explaining that GMP ensures quality and safety in manufacturing while cGMP refers specifically to FDA regulations. The principles and regulations of GMP, cGMP, and their comparison are outlined. Key aspects like facilities, equipment, documentation, packaging and labeling, quality control, and standard operating procedures are summarized.
The document discusses Good Manufacturing Practices (GMP) for pharmaceutical manufacturing. It outlines requirements for facilities, equipment, personnel, documentation, production processes, quality control, and other operational aspects to minimize risks and ensure consistent production of quality products. GMP covers all aspects of production and testing to maintain standards, prevent contamination and errors, and comply with regulatory guidelines.
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A brief presentation on the current good manufacturing practices employed in the manufacture of pharmaceuticals in the US.
Comprises of all aspects of good manufacturing practices
The document provides guidance on regulatory aspects of pharmaceutical and bulk drug manufacture and biotechnology derived products. It discusses quality management principles including establishing a quality unit, conducting internal audits and product quality reviews. It also addresses personnel qualifications and training, building and facility design requirements including utilities and water systems, process equipment cleaning and maintenance, documentation practices, validation procedures, and other quality control aspects.
The GMP Operations Manager is responsible for overseeing the implementation and sustained operations of world-class technical cleaning and sanitization programs to include cGMP space, semi-conductor, clean rooms, laboratory, data and other critical environments.
The document summarizes key aspects of cGMP (current good manufacturing practices) regulations for pharmaceutical products as outlined in parts 210 and 211 of Title 21 of the Code of Federal Regulations. It discusses the responsibilities of quality control units in approving materials, facilities, equipment, processes, records and reports. Key duties of the quality control unit include approving or rejecting components, manufacturing procedures, specifications, drug products and investigating complaints. The quality control unit is meant to function independently to ensure products are made correctly and meet all necessary standards.
The document discusses several issues related to pharmaceutical drugs including direct-to-consumer advertising, Good Manufacturing Practice regulations, problems with drug components from China, the cost of drugs in the US, and advising a loved one about participating in a clinical trial.
The document discusses several issues related to pharmaceutical drugs including direct-to-consumer advertising, Good Manufacturing Practice regulations, problems with drug components from China, the cost of drugs in the US, and advising a loved one about participating in a clinical trial.
A car fell into a river, but the people inside were safely extracted. Efforts are now underway to remove the submerged vehicle from the water. The incident will be reviewed to determine what safety measures or procedures could be improved going forward.
The document provides an overview tour of a Good Manufacturing Practices (GMP) facility, showing various areas and processes involved in pharmaceutical manufacturing. These include powder weighing, granulation, blending, blister packaging, air handling units, bioreactors, sanitary fittings, water purification systems, downstream processing, quality control labs, protective equipment, fermentation suites, filtration, and sterile filling areas. Tables are also included showing cleanroom classifications and maximum particle levels according to international ISO and U.S. federal standards.
1) Several case studies are presented involving FDA regulation violations and their consequences. Schering-Plough ignored repeated FDA warnings and was fined $500 million. Barr Laboratories routinely retested drug batches instead of following procedures for out-of-specification results, leading to a legal case.
2) Chiron's flu vaccine manufacturing plant in the UK had its license suspended in 2004, eliminating nearly half of the US supply that year. Baxter recalled blood thinner Heparin after patients had allergic reactions, which was later traced to a contaminated ingredient from a Chinese supplier.
3) Regulators must take supplier quality into account, as sponsors are responsible for ensuring third-party manufacturers meet standards. The FDA found numerous problems
3 top ten fda warning letter findings by theShirley Roach
The document outlines the top ten most common Good Manufacturing Practice (GMP) findings by the FDA in fiscal year 2003 based on Form 483 observations. The most frequent finding was a failure to follow and/or document written production and process control procedures, which was referenced on 317 Form 483s. Other top findings included responsibilities of the quality control unit, written procedures for production and process controls, testing and release for distribution, and validation. The document also provides examples of common GMP violations found during inspections, such as dirty facilities, unqualified equipment, and lack of corrective and preventative action procedures.
The document provides a history of Good Manufacturing Practices (GMPs) and how they developed in response to public health crises and product contamination issues. It describes key events like the passage of the 1906 Food and Drug Act in response to Upton Sinclair's book "The Jungle" exposing unsanitary meat packing practices. It also discusses the 1938 FD&C Act requiring companies prove product safety, and the finalization of GMP regulations in 1978 in response to issues like the 1955 polio vaccine contamination. Overall it outlines the increasing regulation and standards for pharmaceutical manufacturing over the 20th century to ensure product quality and safety.
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2. Objectives
Have an understanding of the
regulations governing GMP
Have an understanding of application of
regulations
Discuss interpretation of regulations
3. Goal
You will have a basic understanding of
the regulation governing GMPs and be
able to apply this understanding when
presented with examples.
4. GMP – Characteristics
Characteristics of GMP regulations
and interpretations
GMP regulations are largely general and open for interpretation
Benefit:
Manufacturers and researchers are able to
interpret and apply the regulations in ways that
may work best for their unique situations
Risk:
The flexibility may lead to confusion during the
interpretation of the regulation and misapplied
control mechanisms
5. The Regulations
21 CFR Parts 210 and 211 (Drug
Industry)
21 CFR Part 820 (Medical Device
Industry)
21 CFR Part 110 (Food Industry)
21 CFR Part 606 (Blood Industry
6. Part 210
CURRENT GOOD MANUFACTURING
PRACTICE IN
MANUFACTURING, PROCESSING, PA
CKING, OR HOLDING OF DRUGS;
GENERAL
7. Remember “current”
In the US, the phrase "current good
manufacturing practice" appears in 501(B) of
the 1938 Food, Drug, and Cosmetic Act
(21USC351). US courts may theoretically hold
that a drug product is adulterated even if there
is no specific regulatory requirement that was
violated as long as the process was not
performed according to industry standards.
8. Part 211
Subpart A – General Provision
Subpart B – Organization and personnel
Subpart C – Buildings and Facilities
Subpart D – Equipment
Subpart E - Control of Components and
Drug Products Containers and Closures
Subpart F – Production and process
controls
9. Part 211 cont.
Subpart G – Packaging and Labeling
Control
Subpart H – Holding and distribution
Subpart I – Laboratory Controls
Subpart J – Records and Reports
Subpart K – Returned and Salvaged
Drug Products
10. Packaging
and Labeling
Production Control
and Holding and
Process Distribution
Controls
Control of
Laboratory
components and
Drug Product GMP controls
Containers and
Closures
Organization
and Personnel
Equipment
Buildings
and
Facilities
11. Subpart A – General Provisions
Scope - The regulations in this part
contain the minimum current good
manufacturing practice for preparation of
drug products for administration to
humans or animals.
13. Subpart B
211.22 Responsibility of QC
211.25 Personnel Qualifications
211.28 Personnel Responsibilities
211.34 Consultants.
14. Quality Control Unit
The quality control unit shall have the
responsibility for approving or rejecting
all procedures or specifications
impacting on the
identity, strength, quality, and purity of
the drug product.
15. 211.22 Responsibility of Quality
Control Unit
Authorities and Responsibility
Approve or Reject all:
o Components
o Drug Product Container
o Closures
o in-process Materials
o Packaging Materials
o Labeling
o Drug Products
Review Production records to assure no erros have
occurred
If errors have occurred the responsibility to assure
that they have been fully investigated
16. Subpart B – Organization and
Personnel
Personnel qualifications. Each person engaged in the
manufacture, processing, packing, or holding of a drug product
shall have education, training, and experience, or any
combination thereof, to enable that person to perform the
assigned functions.
Personnel responsibilities- Personnel engaged in the
manufacture, processing, packing, or holding of a drug product
shall wear clean clothing appropriate for the duties they perform.
Consultants advising on the manufacture, processing, packing, or
holding of drug products shall have sufficient
education, training, and experience, or any combination
thereof, to advise on the subject for which they are retained
17. Quality Assurance Manual
Should indicate that have a well-
documented Quality Assurance (QA)
program in place.
The QA program should provide a
systematic approach for evaluation,
inspection, testing, calibration or
whatever is needed to monitor and
assure the quality of your product.
18. Qualifications of Personnel (training)
All personnel in manufacturing or management must
have education training and experience or a
combination thereof to perform assigned duties
Training in the GMPs and operations performed by the
employees
Training conducted on a continuing basis by qualified
individuals
Adequate number of personnel to perform functions.
Clean clothing and protective apparel worn as
necessary to protect drug products from contamination
Good sanitation and health habits should be followed.
19. Consultants
Consultants advising on GMP areas and
operations must be qualified by
education, training or experience.
Maintain records of their qualification,
work and address
20. Summary
The quality unit must have the authority
to make independent quality related
decisions.
Personnel must have documented
adequate training & experience.
Training for staff and contractors
22. Subpart C
211.42 Design and Construction
211.44 Lighting
211.46 Ventilation, HVAC
211.48 Plumbing
211.50 Sewage and Refuse
211.52 Washing and Toilet Facilities
211.56 Sanitation
211.58 Maintenance
23. Design
First principle: Quality by Design
GMP requirements for Process Design
211.42 Design of Facility
211.63 Design of Equipment
211.100 Design of Production and
Control Procedures
211.160 Design of Laboratory Controls
24. Buildings and Facilities
The temperature and
relative humidity
should be
controlled, monitored
in accordance with an
SOP, and the results
recorded. The limits
should be appropriate
according to the
materials stored and
product processed
27. Sanitation
Building maintained in a clean and
sanitary condition
Written procedures assigning
responsibility for sanitation methods.
Written procedures for use of suitable
elimination of pests and environmental
contaminants
All agents used must be in accordance
with EPA standards
28. Sanitation
Buildings maintained in a clean and sanitary condition
Written procedures assigning responsibility for
sanitation methods, equipment, materials & schedules
Written procedures for the use of suitable:
Insecticides
Rodenticides
Fungicides
Fumigating agents
Cleaning and sanitizing agents
All pest control products must be registered and used
in accordance with EPA standards.
29. Buildings and Facilities
Separate receiving
and dispatch bays
Materials and
products
protected
from weather
Area to clean
incoming materials
provided
30. Summary
Data must exist to show suitability or
fitness for use of major instruments.,
equipment, and systems.
Control, cleaning and maintenance
prevents contamination
32. Subpart D – Equipment
§ 211.63 Equipment design, size, and
location.
§ 211.65 - Equipment construction.
§ 211.67 - Equipment cleaning and
maintenance.
§ 211.68 - Automatic, mechanical, and
electronic equipment.
§ 211.72 - Filters.
33. Equipment
Adequate space to facilitate cleaning and
maintenance of equipment
To prevent contamination there should
be separate or defined areas or other
control systems for the receipt
identification, storage and withholding of
all materials.
Orderly placement of equipment.
34. Equipment
Design of areas for
weighing of materials
Proper air supply
Dust control measures
(including extraction of
dust and air)
Easily cleanable
surfaces
No areas for dust
accumulation
Protection of
material, product and
operator
35. Equipment
All aspects including
Design, installation,
operation,
performance,
specifications, logs,
maintenance, use,
cleaning,
qualification,
calibration etc…
36. Maintenance Procedures (MP)
Periodic procedures
To minimize the risk of losing raw data and
analytical results
Inspection/replacement of normal wear and
maintenance items
File back-up and recovery
Data archival and retrieval
Security
Lan administration
37. Equipment design size and location
Must be suitable for intended use
Easily cleaned and maintained
Must be non reactive
Lubricants coolants etc. required for
operation should not contact any
component.
38. Equipment Design, Size, and
Location
Must be suitable for Equipment
intend use: Construction
Appropriate design Cannot be
Adequate size Additive
Suitably located Absorptive
Reactive
Facilitate its
Lubricants, coolants
use, cleaning and
maintenance etc. required for
operations should
not contact any
component
39. Equipment Cleaning and
Maintenance
Equipment and utensils
Must be cleaned
Maintained at suitable intervals
Written Procedures
Assign responsibility for cleaning
Include schedules for maintenance
41. Equipment Cleaning and
Maintenance
Equipment and utensils must be cleaned and
maintained at suitable intervals
Written procedures assign responsibility for
cleaning and schedules for maintenance.
State methods, materials and equipment for
cleaning
State disassembly reassembly procedures
Obliteration of previous batch information
Inspection of equipment before use.
42. Written Procedures
State methods, materials and equipment
for cleaning
State disassembly/reassembly methods
Obliteration of pervious batch information
Protection of equipment prior to use
Inspection of equipment immediately
before use
43. Subpart E- Control of
components and drug Product
containers and Closures
44. Subpart E- Control of Components
General requirements.
§ 211.82 - Receipt and storage of untested
components, drug product containers, and closures.
§ 211.84 - Testing and approval or rejection of
components, drug product containers, and closures.
§ 211.86 - Use of approved components, drug
product containers, and closures.
§ 211.87 - Retesting of approved components, drug
product containers, and closures.
§ 211.89 - Rejected components, drug product
containers, and closures.
§ 211.94 - Drug product containers and closures.
45. General Requirements
Written Procedures Handled and stored in a
describing: manner to prevent
Receipt contamination
Identification Bagged or boxed component
Storage
of containers or closure
stored off floor and suitably
Handling
spaced to permit cleaning
Sampling and inspection
Testing Identified with a distinctive
Approval or Rejection code for each lot in each
shipment received
Each lot identified as to its
status: quarantined,
approved, rejected.
46. Component Tests
At least one test must be conducted to verify the
identity of each component of a drug product
Specific identity tests, if they exist, should be used
Each component must be tested for conformity with all
appropriate written specification for
purity, strength, and quality. A certificate of analysis
may be accepted from the supplier provided that:
At least one specific identity test is conducted
The manufacturer has established the reliability of the
supplier’s analyses through appropriate validation of the
supplier's test results at appropriate intervals
47. Containers and Closures
Should not be reactive, additive, or adsorptive
Provide adequate protection against
foreseeable external factors in storage and
use
Clean, and if appropriate, sterilized and
processed to remove pyrogenic properties
Written procedures for: standards or
specifications, methods of testing, and where
indicated, methods of cleaning, sterilizing, and
processing to remove pyrogenic properties
48. Summary
Material must always be released by QC
before they are used.
No provisional releases
Vender CoA must be verified.
50. Subpart F- Production and Process
Controls
Written procedures; deviations.
§ 211.101 - Charge-in of components.
§ 211.103 - Calculation of yield.
§ 211.105 - Equipment identification.
§ 211.110 - Sampling and testing of in-
process materials and drug products.
§ 211.111 - Time limitations on production.
§ 211.113 - Control of microbiological
contamination.
§ 211.115 - Reprocessing.
52. Validation Requirement
Process Validation is an Enforceable
Requirement
Active Pharmaceutical Ingredients
Statutory CGMP provisions of 501(a)(2)(b) of the
Food Drug and Cosmetic Act
No regulations
GMP guidance available - ICH Q7A
53. Goal of Process Validation
Drug product meeting the needs of the
patient, i.e., safe and effective; and has
the identity, strength, purity, and quality
characteristics it is represented to
possess.
Achieved through proper product development
and proper process validation.
55. Validation
Principle
Documented evidence: Process is capable of reliably
and repeatedly rendering a product of the required
quality
Planning, organizing and performing process
validation
Process validation protocols
Data collected and reviewed against predetermined
acceptance criteria – recorded in validation report
58. Pertains to processing steps-
Dispensing to Bulk dose
Written Procedures: Deviations
Change Control
Charge-in of components
Calculation of yield
Equipment ID
Sampling
Production time limits
59. In-process testing
Rejected Product
Action Limits
Target value
Acceptable Range
Action Limits
Rejected Product
60. In-process testing
Rejected Product
Release Specifications
Action Limits
Target value
Acceptable Range
Action Limits
Release Specifications
Rejected Product
61. Summary
Use only valid processes and systems.
Keep adequate records to allow
deviations to be recorded and
investigated.
Make drug products right, first
time, every time.
63. Subpart G – Packaging and
Labeling Control
Materials examination and usage criteria.
§ 211.125 - Labeling issuance.
§ 211.130 - Packaging and labeling
operations.
§ 211.132 - Tamper-evident packaging
requirements for over-the-counter (OTC)
human drug products.
§ 211.134 - Drug product inspection.
§ 211.137 - Expiration dating.
64. Labeling Issuance
Labeling issued for each batch shall be
examined for identity and conformity with
labeling in master or batch records
Reconciliation between labeling issued,
used and returned and product produced
Discrepancies outside of narrow preset
limits, based on historical data, require
an investigation
65. Packaging and Labeling Operations
Written procedures
Procedures should incorporate the following
features:
• Prevention of mix-ups and cross-contamination
• Identification and handling of filled drug containers
• Examination of labels for correctness
• Line inspection before packaging to assure that
lines have been cleared
• Documentation of all activities in the batch record
66. Drug Product Inspection
Examine packaged and labeled products
during finishing operations to assure the
correct label has been used
Collect a representative sample of units
at the completion of finishing and
examined for correct labeling
Record results of the examination of the
batch record
68. Subpart H- Holding and Distribution
§ 211.142 - Warehousing procedures.
§ 211.150 - Distribution procedures.
69. Warehouse Procedures
Written procedures for
Quarantine prior to QC release
Storage under appropriate conditions of
temperature, humidity and light
70. Subpart I lab controls: Instrument
Controls, Training, Standards/Reagents, Te
sting and Release, OOS
72. Out of Specification (OOS)
What does the cGMP Regulation
say about Handling OOS Results?
73. Averaging
Assay results should never be averaged
because averaging hides individual variability:
e.g. 89, 89, 92 (x=90)
Individual content uniformity tests should not be
averaged to obtain passing value
Microbiology averaging is acceptable due to
biological variability
75. General Requirements
Scientifically sound specifications,
standards, sampling plans, test
procedures and other laboratory controls
procedures and any changes should be
drafted by the appropriate organization
and approved by QC
Documented at the time of performance
Deviations recorded and justified
76. Testing and Release
Appropriate laboratory determination of
each lot for conformance to final
specifications
Appropriate laboratory testing of each lot
of drug required to be free of
objectionable microorganisms
77. Stability Defined
Definition (ICH/FDA)
The capacity of a drug substance or drug
product to remain within specifications
established to ensure its
identity, strength, quality and purity
throughout a retest or expirations dating
period.
78. Stability Testing
Written testing program designed to assess
stability of drug and determine expiration dates
Sample size & test interval based on statistical
criteria for each attribute examined.
Storage conditions
Reliable, meaningful and specific test methods.
Utilization of same container/closure system as
marketed drug
Test products for reconstitution at time of
dispensing and after reconstitution
79. Stability Testing
An adequate number of batches need to
be tested to determine the expiration
date.
Accelerated studies, combined with data
from long-term stability studies support
tentative expiration dates.
Expiration dates assigned from
accelerated study data much be verified
by ongoing shelf-life studies
80. Reserve Samples
2X quantity for tests (except sterility
&pyrogen)
Representative samples, selected
statistically, examined visually at least
annually for deterioration
Any evidence of deterioration shall be
investigated and results maintained with
other stability data
82. Subpart J- Records and Reports
§ 211.180 - General requirements.
§ 211.182 - Equipment cleaning and use log.
§ 211.184 - Component, drug product
container, closure, and labeling records.
§ 211.186 - Master production and control
records.
§ 211.188 - Batch production and control
records.
§ 211.192 - Production record review.
§ 211.194 - Laboratory records.
§ 211.196 - Distribution records.
§ 211.198 - Complaint files.
86. TYPE OF GMP DOCUMENTS
QUALITY MANUAL
S.O.P.
Equipment Status
Master production Specification/ Testing Work Protocol Identity/ Material Status
document Standard Method (WP) Label Product Status
Master Formula Raw & packaging material
Master Prod. Procedure Bulk Validation Protocol Report
Master Pack. Procedure Finished product Sampling record
Testing result record and report
Microbial and particle monitoring record
Batch Production Record Stability test record
Return Product Handling Record
Recall Record
Product Destruction Record Note :
Product Complaint Record •Blue : WI (standard, specification & procedure)
Distribution Record •Red : record
87. Not until
Can we ship the
this batch? paperwork
is released!
QC
Lot no.
XYZ
88. The GMP Paperwork is a
Product
The paperwork
produced is of equal
importance to the
products produced.
Product = Paperwork
89. General Requirements
Retain all records at least 1 year after
expiration date of the batch
OTC drugs lacking expiration dates
retain all records for at least 3 years after
distribution of the batch
Records for components, containers,
closures, and labeling follow the same
rules.
90. cGMP Part 211.192
The failure of a batch or any of its components
to meet any of its specifications shall be
thoroughly investigated…
The investigation shall extend to other batches
of the same drug product and other drug
products that may have been associated with
the specific failure of discrepancy…
91. cGMP Part 211.194
A written record of the investigation shall
include the conclusions and follow-up…
A complete record of all data secured in the
course of each test…
Complete records shall be maintained of all
stability testing performed…
94. General Requirements
Written Procedures Handled and stored
describing in a manner to
handle
o Receipt
contamination
o Identification
Stored off the floor
o Storage
Identified with a
o Handling distinctive code
o Stamping Each lot identified as
o Testing to its status
o Approval or quarantined, approv
rejection ed or rejected
96. Subpart K – Returned and Salvaged
Drug Products
§ 211.204 - Returned drug products.
§ 211.208 - Drug product salvaging.
97. Returned and Salvaged Drugs
Returned Drug Products
Shall be identified and held
If the condition of the drug, packaging or
labeling casts doubt on its safety, identity,
strength, quality or purity, it must be
destroyed unless examination, testing, or
investigation proves the drug meets its
specifications.
99. Packaging
and Labeling
Production Control
and Holding and
Process Distribution
Controls
Control of
Laboratory
components and
Drug Product GMP controls
Containers and
Closures
Organization
and Personnel
Equipment
Buildings
and
Facilities
100. This is for your family…
Manufacture
Raw
Materials Dispense
101. A word about Drug Master File…
http://wwwbdp.ncif
crf.gov/pdf1/Guidet
oRegSubsR1.pdf