This document outlines good manufacturing practices (GMP) for premises, materials, equipment, and documentation used in pharmaceutical manufacturing. It discusses requirements for building location and design, waste disposal, water systems, storage areas, production areas, personnel, and sanitation. Specific guidelines are provided for raw material receipt and storage, manufacturing operations, equipment use and maintenance, and documentation and record keeping. The goal is to ensure proper conditions and controls are in place to prevent mix-ups, contamination, and to allow for efficient production of quality pharmaceutical products.
1. Pharmaceutical plant layout involves arranging departments and machinery to integrate machines, materials, and personnel for efficient production while following safety and regulatory requirements.
2. There are two main types of layouts - process layout which groups similar machines together and product layout which arranges machines in the order of operations.
3. Effective planning of production involves selecting the process, materials, and equipment; determining the layout; and creating routing sheets and schedules to optimize resource usage and meet production targets.
Auditing of vendors and production departmentArpitSuralkar
This document outlines procedures for auditing vendors that produce capsules and sterile products. It discusses the benefits of vendor audits such as cost savings, process improvements, and risk reduction. The document describes the vendor selection process and provides a checklist for auditing vendors, which includes evaluating their premises, personnel, documentation, validation procedures, samples, stability studies, and drug recall processes. The goal of vendor audits is to inspect vendors' quality management systems and ensure they meet requirements for producing capsules and sterile medical products.
The document discusses the design and layout considerations for pharmaceutical manufacturing facilities. It states that premises should be located to minimize risks of cross-contamination from external sources. The interior surfaces should be smooth and allow for easy cleaning. Specific areas for different processes like manufacturing, packaging, laboratories should be separated but laid out in a logical flow. Material and personnel flow should be organized to prevent mix-ups and cross-contamination. Tables and figures provide examples of suitable layouts for manufacturing tablets and liquid oral preparations.
This document discusses plant layout for pharmaceutical manufacturing facilities. It begins by defining plant layout and its importance for efficient production. There are two main types of layouts: process/functional layout which groups similar machines together and product/straight line layout which arranges machines in the order of operations. Key factors that influence layout include the production process, available space, operational convenience, and regulatory requirements. Special provisions for pharmaceutical facilities include preventing confusion or contamination. Storage areas for raw materials and finished goods are also discussed, including specific storage requirements. The document concludes by outlining the layout of sterile or aseptic manufacturing areas which separate different operations and control air flow and personnel movement to maintain sterility.
This document provides a GMP checklist for inspecting active pharmaceutical ingredient manufacturing facilities. It covers various aspects of facility design and operations including building construction, warehousing, production areas, quality control, personnel, and sanitation. The checklist contains over 100 questions to evaluate compliance with WHO, ICH, and EU GMP guidelines regarding location, premises, equipment, personnel, sanitation, production, quality control, and documentation. Facilities are required to provide detailed responses and evidence to demonstrate adherence to good manufacturing practices.
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.
This document describes quality control tests performed on suppositories, including weight variation testing to ensure suppositories are uniformly sized, hardness testing to evaluate structural integrity, disintegration testing to assess dissolution rate, and drug content testing to verify active ingredient levels. Dissolution testing was also conducted using a basket apparatus to analyze drug release over time in vitro. Finally, short term stability studies were performed on promising formulations by storing samples at room temperature and refrigeration for 6 weeks and testing for drug content and dissolution profile.
Cleaning validation is important to ensure safety and prevent contamination during pharmaceutical production. It involves collecting data to prove cleaning procedures consistently remove residues to acceptable limits. Key aspects of validation include defining cleaning procedures, acceptance criteria, sampling methods, and analytical techniques. Validation should continue if procedures or products change. Overall, cleaning validation demonstrates equipment is suitably cleaned between batches to maintain quality as required by cGMP regulations.
1. Pharmaceutical plant layout involves arranging departments and machinery to integrate machines, materials, and personnel for efficient production while following safety and regulatory requirements.
2. There are two main types of layouts - process layout which groups similar machines together and product layout which arranges machines in the order of operations.
3. Effective planning of production involves selecting the process, materials, and equipment; determining the layout; and creating routing sheets and schedules to optimize resource usage and meet production targets.
Auditing of vendors and production departmentArpitSuralkar
This document outlines procedures for auditing vendors that produce capsules and sterile products. It discusses the benefits of vendor audits such as cost savings, process improvements, and risk reduction. The document describes the vendor selection process and provides a checklist for auditing vendors, which includes evaluating their premises, personnel, documentation, validation procedures, samples, stability studies, and drug recall processes. The goal of vendor audits is to inspect vendors' quality management systems and ensure they meet requirements for producing capsules and sterile medical products.
The document discusses the design and layout considerations for pharmaceutical manufacturing facilities. It states that premises should be located to minimize risks of cross-contamination from external sources. The interior surfaces should be smooth and allow for easy cleaning. Specific areas for different processes like manufacturing, packaging, laboratories should be separated but laid out in a logical flow. Material and personnel flow should be organized to prevent mix-ups and cross-contamination. Tables and figures provide examples of suitable layouts for manufacturing tablets and liquid oral preparations.
This document discusses plant layout for pharmaceutical manufacturing facilities. It begins by defining plant layout and its importance for efficient production. There are two main types of layouts: process/functional layout which groups similar machines together and product/straight line layout which arranges machines in the order of operations. Key factors that influence layout include the production process, available space, operational convenience, and regulatory requirements. Special provisions for pharmaceutical facilities include preventing confusion or contamination. Storage areas for raw materials and finished goods are also discussed, including specific storage requirements. The document concludes by outlining the layout of sterile or aseptic manufacturing areas which separate different operations and control air flow and personnel movement to maintain sterility.
This document provides a GMP checklist for inspecting active pharmaceutical ingredient manufacturing facilities. It covers various aspects of facility design and operations including building construction, warehousing, production areas, quality control, personnel, and sanitation. The checklist contains over 100 questions to evaluate compliance with WHO, ICH, and EU GMP guidelines regarding location, premises, equipment, personnel, sanitation, production, quality control, and documentation. Facilities are required to provide detailed responses and evidence to demonstrate adherence to good manufacturing practices.
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.
This document describes quality control tests performed on suppositories, including weight variation testing to ensure suppositories are uniformly sized, hardness testing to evaluate structural integrity, disintegration testing to assess dissolution rate, and drug content testing to verify active ingredient levels. Dissolution testing was also conducted using a basket apparatus to analyze drug release over time in vitro. Finally, short term stability studies were performed on promising formulations by storing samples at room temperature and refrigeration for 6 weeks and testing for drug content and dissolution profile.
Cleaning validation is important to ensure safety and prevent contamination during pharmaceutical production. It involves collecting data to prove cleaning procedures consistently remove residues to acceptable limits. Key aspects of validation include defining cleaning procedures, acceptance criteria, sampling methods, and analytical techniques. Validation should continue if procedures or products change. Overall, cleaning validation demonstrates equipment is suitably cleaned between batches to maintain quality as required by cGMP regulations.
Distribution, Electronic data handling and controlled documentation by Khushb...KhushbooKunkulol
This document discusses documentation, distribution, and electronic data handling procedures for pharmaceutical companies. It contains the following key points:
1. Documentation procedures ensure standardized and unambiguous procedures are followed to minimize errors. Distribution records must allow for efficient product recall if needed.
2. Electronic data handling uses computers to collect, store, and analyze data. It generates audit trails and records for activities like batch production. The ALCOA principles provide guidelines for ensuring electronic data is attributable, legible, contemporaneous, original, and accurate.
3. Controlled documents are subject to versioning and access restrictions to ensure only the correct version is used. Uncontrolled documents are not versioned and can be freely edited for reference purposes.
This document discusses vendor certification and categorization. It defines vendor certification as ensuring a vendor will meet regulatory expectations. Vendors are categorized from 1 to 4 based on risk, with category 1 being experts with minimal monitoring and category 4 being sole-source API manufacturers requiring intense monitoring. The document also outlines the vendor qualification process, including selection criteria, evaluation of production processes, and standard procedures for quality audits.
The document discusses in-process quality control (IPQC) and final product quality control (FPQC) tests for parenteral pharmaceuticals. It defines parenterals as sterile dosage forms intended for administration other than orally to directly enter systemic circulation. The types of parenterals are described based on volume and packaging. Important IPQC tests are outlined including conductivity, pH, temperature monitoring and volume filled verification. Key FPQC tests for parenterals involve sterility testing, pyrogen testing, clarity evaluation, leakage assessment, uniformity of content and weight tests, and extractable volume determination. Methods for each test are concisely explained.
GMP is the part of Quality Management which ensures that the products are consistently produced and controlled to the quality standard appropriate to their intended use as required by the marketing authorization and product specification. (Reference: WHO)
In contrast, cGMP i.e. ‘c’ before the GMP is indicative of the constantly changing technologies and systems which are up-to-date in order to comply with the regulations. These the dynamic changes in Good Manufacturing Practice to make Pharmaceuticals manufacture foul proof; assuring a high level of confidence in the safety and efficacy of the product.
Batch packaging record for sterile water for injection Ritika Patel
This document provides a template for a batch packaging record for sterile water for injection. It includes sections for documentation, packaging instructions, components of a batch packaging record, and a formatted example for sterile water for injection. The format example includes sections for packaging operation details, in-process checks, packaging description, labeling and packaging material details, packaging operation records, total quantity packed, and sign-offs. The purpose is to document the packaging process and ensure quality.
“A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product”.
CGMP guidelines, CFR, CDER and CBER, PIC/S, Environment control in pharma industry, plant layout, maintenance of sterile area, Clean room classification, Environmental monitoring, Types of contaminants in pharma industry & Good Warehousing Practices.
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.
Manufacturing operations and controls are important to ensure the identity, strength, safety, and purity of pharmaceutical products. Key aspects include sanitizing manufacturing premises, preventing mix-ups and cross contamination, processing intermediates and bulk products while maintaining quality, conducting packaging operations with controls, in-process quality control testing during manufacturing and packaging, and only releasing finished products that meet all requirements after quality approval. Maintaining proper documentation and investigating any deviations or unusual events are also important parts of manufacturing and quality control.
This document provides an overview of quality assurance, good manufacturing practices (GMP), and good laboratory practices (GLP). It defines each concept and outlines their key principles and goals. Quality assurance aims to ensure products meet the required quality standards and involves implementing GMP, GLP, and other quality control measures. GMP focuses on establishing processes to minimize risks like contamination during manufacturing. GLP provides a quality system for non-clinical health and safety studies to ensure they are properly planned, performed, documented and reported.
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
This document discusses the requirements for manufacturing facilities and clinical trials in India according to Schedules M and Y of the Drugs and Cosmetics Rules. Schedule M outlines the good manufacturing practices and requirements for premises, plants, and equipment used in pharmaceutical production. It also discusses facility design aspects like clean surroundings, building facilities, lighting, ventilation, and storage areas. Schedule Y provides the guidelines for conducting clinical trials in India, including the various phases of trials from Phase 0 to Phase IV. It also discusses aspects like informed consent, ethics committee composition, and government facilities for expediting clinical trials.
This document discusses regulations regarding the manufacture of pharmaceutical products and active ingredients, including requirements for qualifying vendors that supply materials. Strict good manufacturing practices (GMP) are required to ensure quality, safety and efficacy. Vendor qualification is important to provide assurance of drug product performance and avoid risks like contamination. The document refers to other guidance on topics like quality agreements, auditing, and assessing vendor performance on supply assurance, quality, costs, and responsiveness. Packaging component supplier audits are also discussed.
This document provides an overview of calibration and qualification processes. It discusses:
1. The purpose and importance of calibrating instruments to ensure accuracy and traceability. Regular calibration helps minimize measurement drift.
2. The four phases of qualification for analytical instrumentation: design qualification verifies design suitability; installation qualification confirms proper installation; operational qualification verifies functionality; and performance qualification confirms ability to achieve expected results.
3. Key aspects of each qualification phase including documentation of design requirements, verification of installation per specifications, and confirmation of operational ability and performance. Qualification ensures measurement reliability.
Mr. Krushnakant K. Wable gave a presentation on current good manufacturing practices (cGMP) under the guidance of Dr. Sonali Mahaparale and Dr. D. Y. Patil. The presentation defined cGMP as regulations enforced by the FDA to ensure proper design, monitoring, and control of manufacturing processes and facilities. It also explained that cGMP helps assure the identity, strength, quality and purity of drug products. The presentation covered key components of cGMP like personnel, premises, equipment, standard operating procedures, raw materials, self inspections, and warehousing. It emphasized that cGMP helps prevent contamination, mix-ups, failures and errors to ensure products meet quality standards.
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.
Principles of Drug Discovery and DevelopmentMANIKANDAN V
This document provides an overview of the drug development and approval process, including:
1) Drug discovery typically involves new disease insights, testing molecular compounds, existing treatments with unexpected effects, or new technologies. Thousands of candidates are narrowed down based on early testing.
2) Once a compound looks promising, development involves experiments to understand absorption, benefits, dosage, delivery method, side effects, and effectiveness compared to other drugs.
3) The FDA approval process includes multiple phases of clinical trials involving healthy volunteers and patients to evaluate safety, efficacy, and side effect management strategies before approval or accelerated approval in some cases.
This document discusses general requirements and standards for materials used in the production of biological products. It covers topics such as starting materials, packaging materials, finished products, waste materials, reference standards, and documentation requirements. Maintaining appropriate storage conditions, purchasing controls, labeling, and record keeping are important across all material types to ensure quality and prevent mix-ups or contamination. Reference standards must be stable and available in sufficient quantities to allow testing over several years and ensure uniformity and reliability of results.
This document outlines Good Manufacturing Practices (GMP) guidelines for drug manufacturing facilities. It addresses requirements for facility premises, materials, production areas, quality control, personnel, and sanitation. Key requirements include preventing contamination risks through proper building/area design, segregation of incompatible operations, control of air handling systems, cleaning procedures, personnel training, and health/hygiene practices. The guidelines are intended to ensure consistent high quality drug production under hygienic conditions.
Distribution, Electronic data handling and controlled documentation by Khushb...KhushbooKunkulol
This document discusses documentation, distribution, and electronic data handling procedures for pharmaceutical companies. It contains the following key points:
1. Documentation procedures ensure standardized and unambiguous procedures are followed to minimize errors. Distribution records must allow for efficient product recall if needed.
2. Electronic data handling uses computers to collect, store, and analyze data. It generates audit trails and records for activities like batch production. The ALCOA principles provide guidelines for ensuring electronic data is attributable, legible, contemporaneous, original, and accurate.
3. Controlled documents are subject to versioning and access restrictions to ensure only the correct version is used. Uncontrolled documents are not versioned and can be freely edited for reference purposes.
This document discusses vendor certification and categorization. It defines vendor certification as ensuring a vendor will meet regulatory expectations. Vendors are categorized from 1 to 4 based on risk, with category 1 being experts with minimal monitoring and category 4 being sole-source API manufacturers requiring intense monitoring. The document also outlines the vendor qualification process, including selection criteria, evaluation of production processes, and standard procedures for quality audits.
The document discusses in-process quality control (IPQC) and final product quality control (FPQC) tests for parenteral pharmaceuticals. It defines parenterals as sterile dosage forms intended for administration other than orally to directly enter systemic circulation. The types of parenterals are described based on volume and packaging. Important IPQC tests are outlined including conductivity, pH, temperature monitoring and volume filled verification. Key FPQC tests for parenterals involve sterility testing, pyrogen testing, clarity evaluation, leakage assessment, uniformity of content and weight tests, and extractable volume determination. Methods for each test are concisely explained.
GMP is the part of Quality Management which ensures that the products are consistently produced and controlled to the quality standard appropriate to their intended use as required by the marketing authorization and product specification. (Reference: WHO)
In contrast, cGMP i.e. ‘c’ before the GMP is indicative of the constantly changing technologies and systems which are up-to-date in order to comply with the regulations. These the dynamic changes in Good Manufacturing Practice to make Pharmaceuticals manufacture foul proof; assuring a high level of confidence in the safety and efficacy of the product.
Batch packaging record for sterile water for injection Ritika Patel
This document provides a template for a batch packaging record for sterile water for injection. It includes sections for documentation, packaging instructions, components of a batch packaging record, and a formatted example for sterile water for injection. The format example includes sections for packaging operation details, in-process checks, packaging description, labeling and packaging material details, packaging operation records, total quantity packed, and sign-offs. The purpose is to document the packaging process and ensure quality.
“A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product”.
CGMP guidelines, CFR, CDER and CBER, PIC/S, Environment control in pharma industry, plant layout, maintenance of sterile area, Clean room classification, Environmental monitoring, Types of contaminants in pharma industry & Good Warehousing Practices.
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.
Manufacturing operations and controls are important to ensure the identity, strength, safety, and purity of pharmaceutical products. Key aspects include sanitizing manufacturing premises, preventing mix-ups and cross contamination, processing intermediates and bulk products while maintaining quality, conducting packaging operations with controls, in-process quality control testing during manufacturing and packaging, and only releasing finished products that meet all requirements after quality approval. Maintaining proper documentation and investigating any deviations or unusual events are also important parts of manufacturing and quality control.
This document provides an overview of quality assurance, good manufacturing practices (GMP), and good laboratory practices (GLP). It defines each concept and outlines their key principles and goals. Quality assurance aims to ensure products meet the required quality standards and involves implementing GMP, GLP, and other quality control measures. GMP focuses on establishing processes to minimize risks like contamination during manufacturing. GLP provides a quality system for non-clinical health and safety studies to ensure they are properly planned, performed, documented and reported.
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
This document discusses the requirements for manufacturing facilities and clinical trials in India according to Schedules M and Y of the Drugs and Cosmetics Rules. Schedule M outlines the good manufacturing practices and requirements for premises, plants, and equipment used in pharmaceutical production. It also discusses facility design aspects like clean surroundings, building facilities, lighting, ventilation, and storage areas. Schedule Y provides the guidelines for conducting clinical trials in India, including the various phases of trials from Phase 0 to Phase IV. It also discusses aspects like informed consent, ethics committee composition, and government facilities for expediting clinical trials.
This document discusses regulations regarding the manufacture of pharmaceutical products and active ingredients, including requirements for qualifying vendors that supply materials. Strict good manufacturing practices (GMP) are required to ensure quality, safety and efficacy. Vendor qualification is important to provide assurance of drug product performance and avoid risks like contamination. The document refers to other guidance on topics like quality agreements, auditing, and assessing vendor performance on supply assurance, quality, costs, and responsiveness. Packaging component supplier audits are also discussed.
This document provides an overview of calibration and qualification processes. It discusses:
1. The purpose and importance of calibrating instruments to ensure accuracy and traceability. Regular calibration helps minimize measurement drift.
2. The four phases of qualification for analytical instrumentation: design qualification verifies design suitability; installation qualification confirms proper installation; operational qualification verifies functionality; and performance qualification confirms ability to achieve expected results.
3. Key aspects of each qualification phase including documentation of design requirements, verification of installation per specifications, and confirmation of operational ability and performance. Qualification ensures measurement reliability.
Mr. Krushnakant K. Wable gave a presentation on current good manufacturing practices (cGMP) under the guidance of Dr. Sonali Mahaparale and Dr. D. Y. Patil. The presentation defined cGMP as regulations enforced by the FDA to ensure proper design, monitoring, and control of manufacturing processes and facilities. It also explained that cGMP helps assure the identity, strength, quality and purity of drug products. The presentation covered key components of cGMP like personnel, premises, equipment, standard operating procedures, raw materials, self inspections, and warehousing. It emphasized that cGMP helps prevent contamination, mix-ups, failures and errors to ensure products meet quality standards.
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.
Principles of Drug Discovery and DevelopmentMANIKANDAN V
This document provides an overview of the drug development and approval process, including:
1) Drug discovery typically involves new disease insights, testing molecular compounds, existing treatments with unexpected effects, or new technologies. Thousands of candidates are narrowed down based on early testing.
2) Once a compound looks promising, development involves experiments to understand absorption, benefits, dosage, delivery method, side effects, and effectiveness compared to other drugs.
3) The FDA approval process includes multiple phases of clinical trials involving healthy volunteers and patients to evaluate safety, efficacy, and side effect management strategies before approval or accelerated approval in some cases.
This document discusses general requirements and standards for materials used in the production of biological products. It covers topics such as starting materials, packaging materials, finished products, waste materials, reference standards, and documentation requirements. Maintaining appropriate storage conditions, purchasing controls, labeling, and record keeping are important across all material types to ensure quality and prevent mix-ups or contamination. Reference standards must be stable and available in sufficient quantities to allow testing over several years and ensure uniformity and reliability of results.
This document outlines Good Manufacturing Practices (GMP) guidelines for drug manufacturing facilities. It addresses requirements for facility premises, materials, production areas, quality control, personnel, and sanitation. Key requirements include preventing contamination risks through proper building/area design, segregation of incompatible operations, control of air handling systems, cleaning procedures, personnel training, and health/hygiene practices. The guidelines are intended to ensure consistent high quality drug production under hygienic conditions.
This document provides an overview of GMP manufacturing environments. It discusses how manufacturing environments impact product quality and outlines factors like personnel, equipment, and premises that contribute to quality. The presentation covers cleanroom classifications, levels of protection, sources of contamination, and parameters that define manufacturing environments like air cleanliness, temperature, and pressure. It emphasizes that the environment is critical for preventing contamination and cross-contamination. Cleanroom class depends on the manufacturing process and corresponding levels of protection must be defined based on critical parameters from the air handling system and additional measures.
The US Food and Drug Administration (FDA) regulates food, drugs, medical devices, vaccines, and other products in the United States. The FDA is responsible for protecting public health by ensuring the safety and security of these products. It evaluates the safety and efficacy of new drugs and monitors approved drugs for safety issues. The FDA aims to provide accurate science-based information to the public and encourages participation in its regulatory process through public dockets. It works with international authorities like those in India to ensure safety standards for products exported to the US.
This document provides an introduction and overview of Good Manufacturing Practices (GMPs). It discusses the history and importance of GMPs in ensuring drug safety. GMPs are regulations followed by pharmaceutical companies and enforced by government agencies to ensure consistency and quality in manufacturing. The document outlines the key aspects of GMPs, including requirements for facilities, equipment, personnel, sanitation, materials testing, manufacturing controls, quality control, documentation, and specific rules for sterile products.
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 definitions and descriptions related to Good Manufacturing Practices (GMP) regulations for pharmaceutical manufacturing. It defines key terms like active pharmaceutical ingredient, batch, and validation. It describes GMP requirements for facilities, equipment, documentation, personnel training, hygiene practices, and prevention of cross-contamination. The goal of GMP is to ensure manufactured products are safe, pure and effective.
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 discusses quality control, quality assurance, and total quality management. It defines quality as meeting or exceeding customer expectations through consistent standards and processes. Quality control focuses on identifying defects during production, while quality assurance aims to prevent defects through upfront planning and audits. Both work together to deliver high quality outputs, increase efficiency, and ensure customer satisfaction. Total quality management requires company-wide commitment to quality through elements like training, teamwork, statistical methods, and customer service. It also discusses quality design, benchmarking, and factors important for quality in the construction industry.
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.
Quality assurance and quality control are important concepts in pharmaceutical manufacturing. Quality assurance refers to planned and systematic activities that ensure quality in processes, while quality control refers to activities that ensure quality in products. Some key differences are that quality assurance focuses on preventing defects through proper processes, while quality control identifies defects in finished products. Total quality management aims to produce perfect products through quality measures at every stage of production and requires team effort across an organization.
The document discusses Good Manufacturing Practices (GMP) and contamination prevention. It covers types of contamination, sources, and how to prevent them through practices like personal hygiene, sanitation, cleaning, and equipment maintenance. GMP regulations require facilities, equipment, personnel training, and documentation to help assure product quality and safety.
This document discusses quality assurance in healthcare. It defines quality and quality assurance, and lists their objectives. Quality is defined as the degree to which health services increase desired health outcomes consistent with current knowledge. Quality assurance aims to continuously evaluate healthcare services and their impact. The key objectives of quality assurance are to ensure quality patient care and demonstrate provider efforts to achieve best results. It also outlines various models, components, principles, approaches, factors, barriers, and the nurse's role in quality assurance.
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
SCHEDULE M, Pharmaceutical Jurisprudence, 5th semnaikanu3813
The document outlines Good Manufacturing Practice (GMP) requirements for pharmaceutical manufacturing facilities, equipment, and processes according to Schedule M of the Drugs and Cosmetics Act in India. It covers 17 parts with specific requirements for premises, plant, equipment, production, packaging, quality control, documentation and other key aspects. Adherence to GMP helps ensure pharmaceutical products are consistently manufactured and controlled to the quality standards appropriate for their intended use.
The document outlines the Good Manufacturing Practice (GMP) requirements for pharmaceutical manufacturing facilities according to Schedule M. It discusses 14 parts that cover requirements for facility premises, equipment, sanitation, personnel, materials, production, quality control, documentation, and quality assurance. The goal of GMP is to ensure consistent production of quality pharmaceutical products by having standardized operating procedures, trained staff, suitable premises and equipment, and validated processes.
This document outlines good manufacturing practices (GMP) for Ayurvedic, Siddha, and Unani medicines. It discusses infrastructure requirements for manufacturing facilities, including adequate space for receiving raw materials, manufacturing, quality control, finished goods storage, and offices. It also covers requirements for buildings, water supply, waste disposal, cleaning of containers, storage, and machinery/equipment. Worker health, clothing, sanitation, and medical services are also addressed. The objective is to ensure raw materials are authentic and contamination-free, manufacturing follows the proper process, quality control measures are in place, and the finished drug is of acceptable quality.
cGMP as per shedule M outlines the Good Manufacturing Practices that must be followed for pharmaceutical manufacturing according to the Drugs and Cosmetics Act of India. It covers requirements for facilities, equipment, personnel, sanitation, documentation, quality control, packaging and labeling. All aspects of production from raw materials to finished products must meet GMP standards to ensure consistency and quality of manufactured drugs. Detailed written procedures and records are required for all manufacturing processes.
1. The document discusses Good Manufacturing Practices (GMP) regulations for Schedule M drugs and cosmetics in India.
2. It covers GMP requirements for premises, equipment, sanitation, personnel, production, quality control, documentation and other areas to ensure consistent high quality of pharmaceutical products.
3. Key aspects include requirements for manufacturing facilities, warehouses, equipment calibration, personnel training, hygiene, production supervision, validation of cleaning procedures, and maintenance of records to allow traceability of all manufacturing steps.
Good Manufacturing Practices (GMP) regulations were introduced in 1988 and amended in 2001 to ensure pharmaceutical products are consistently produced and controlled according to quality standards. GMP covers all aspects of production from starting materials to training and hygiene of staff. Detailed written procedures and documented proof of following correct procedures are required at each step of manufacturing. The goal is to minimize risks that cannot be detected by final testing and ensure consumers receive products of the specified quality.
GMP is a set of principles and procedures that ensure products are consistently manufactured and controlled according to quality standards for their intended use. Key aspects of GMP include requirements for facilities, equipment, personnel, documentation, raw materials, production, packaging and labeling, quality control, self-inspection and product recalls. GMP regulations in India were introduced in 1988 and amended in 2001, embracing rules under the Drugs and Cosmetics Rules 1945. Facilities must be designed and maintained to allow production under hygienic conditions in order to prevent contamination and cross-contamination.
This slides contain description about SCHEDULE T good manufacturing process of Indian system of medicine contains about the process of GMP in indian system of medicine...
Design and Construction of plant as per the GMP Guidelines.pdfMohiniTawade
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
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.
Schedule M specifies Good Manufacturing Practices (GMP) requirements for pharmaceutical manufacturing facilities, equipment, personnel, and documentation in India. It addresses requirements for premises, production areas, quality control laboratories, raw materials, equipment, sanitation, manufacturing operations, packaging, and quality assurance. The goal is to ensure pharmaceutical products are manufactured safely and meet quality standards.
PHARMACEUTICAL PRODUCTION MANAGEMENT & INVENTORY CONTROLArunpandiyan59
1. The document outlines requirements for modern pharmaceutical production facilities including location, building design, waste disposal, storage, production, and quality control. Key requirements include preventing contamination, ensuring hygienic conditions, and separating different categories of drugs.
2. Specific sections cover water treatment systems, warehousing, production area layout, quality control laboratory independence, personnel training, and inventory/raw material management. Equipment must be properly located, maintained and defective units removed.
3. Quality assurance systems must ensure pharmaceutical products meet GMP standards and are developed to requirements for design, development, manufacturing and quality management.
The document outlines the Good Manufacturing Practices (GMP) as per Schedule M of the Drugs and Cosmetic Act of 1940 in India. It details the requirements for facilities, equipment, production, quality control, documentation, personnel and other aspects of pharmaceutical manufacturing. The key points covered include requirements for premises location, building design to prevent contamination, waste disposal procedures, manufacturing controls, quality control testing, documentation and record keeping, personnel qualifications, and compliance with other applicable regulations.
Good Manufacturing Practices (GMP) ensure that products are consistently produced and controlled according to quality standards for their intended use. GMP requirements include clearly defined and validated manufacturing processes, qualified personnel, suitable premises and equipment, approved procedures and instructions, and record keeping. Facilities, equipment, and operations must be designed and maintained to minimize risks of contamination and ensure quality.
This presentation describes Schedule M of Drugs & Cosmetic Act. It consists of Good Manufacturing Practices (GMP) for the manufacturing of drugs. Detailed guidelines about factory premises, machinery, process, quality control, etc. have been given.
Hygiene standards and procedures usually described as Good Hygienic Practices (GHP) or Good Manufacturing Practices (GMP), have been in place for many years and constituted an essential tool in traditional food control. These concepts are still essential in a modern food control system by providing the basic environmental and operating conditions for production of safe food and thus being a requisite or foundation for HACCP in an overall food safety management program. What is new is the concept of formalizing the prerequisite program alongside HACCP and the legal requirement in some countries (USA) of documented monitoring of certain sanitation areas.
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.
GMP, Goods manufacturer Practices, Drug and Cosmetic actDrSampuranSuahg
GMP (good manufacturing practices) regulations ensure that pharmaceutical products are consistently manufactured and controlled according to quality standards. Key aspects of GMP include maintaining high standards for facilities, equipment, production processes, packaging and labeling, quality control testing, record keeping, and personnel qualifications. GMP helps to minimize risks of contamination and ensures that products meet specifications for identity, strength, quality, purity and safety.
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2. Different parts of GMP
PART I
GOOD MANUFACTURING
PRACTICES
FOR PREMISES
AND MATERIALS
PART II
REQUIREMENTS OF PLANT AND
EQUIPMENT
3. PART I
GOOD MANUFACTURING
PRACTICES FOR PREMISES AND
MATERIALS
1.GENERAL REQUIREMENTS
1.1. Location and surroundings.—
The factory building(s) for manufacture of drugs
shall have such measures as to avoid risk of
contamination from external environment including
open sewage, drain, odour, fumes, dust, smoke,
chemical.
4. 1.2. Buildings and premises.—
The premises used for manufacturing,
packaging,labelling and testing purposes shall be
processing,
warehousing,
(i)
compatible with other drug manufacturing operations .
(ii) adequately provided with working space to allow for equipment, materials.
(a) avoid the risk of mix-up between different categories of drugs or with raw
materials, and in-process material.
(b) avoid the possibilities of contamination and cross-contamination.
5. (iii) designed / constructed / maintained to prevent entry of
insects, pests , birds. Interior surface shall be smooth and free
from cracks, and permit easy cleaning painting and disinfection.
(iv) with air control facilities and to maintain conditions including
temperature , humidity.
(v) Provided with drainage system, as specified for the various
categories of products, which shall be of adequate size.
6. 1.3 Water system:—
Purified Water so produced shall only be used for
all the operations except washing and cleaning
operations where potable water may be used. Water
shall be stored in tanks, which do not adversely affect
quality of water and ensure freedom from
microbiological growth. The tank shall be cleaned
periodically and records maintained by the licensee in
this behalf.
7. 1.4 Disposal of waste:-
(i)The disposal of sewage and effluents (solid, liquid
and gas) from the manufacturing shall be in conformity
with the requirements of environment Pollution Control
Board.
(ii) All bio-medical waste shall be destroyed.
(iii)Hazardous, toxic substances and flammable
materials shall be stored and segregated.
8. 2. WAREHOUSING AREA
2.1)Warehousing areas shall be designed to allow
sufficient and various categories of materials and
products like starting and packaging materials,
intermediates bulk and finished products, machine and
equipment spare parts and change items.
2.2)To ensure good storage conditions, They shall be
clean, dry and maintained storage conditions are
required viz temperature, humidity. Proper racks, and
platforms shall be provided for the storage of
materials.
9. 2.3)There shall be a separate sampling area in the
warehousing area for active raw materials. If sampling
is performed in any other area, it shall be conducted in
such a way as to prevent contamination, crosscontamination and mix-up.
2.5) Printed packaging material shall be stored in safe,
separate and secure areas.
10. 3 PRODUCTION AREA
3.1) The production area shall be designed to
allow the production preferably in unit-flow and
with logical sequence of operations.
3.2) In order to avoid the risk of crosscontamination, separate dedicated and selfcontained facilities shall be made available for
the production of sensitive pharmaceutical
products like penicillin or biological preparations
with live microorganisms.
11. 3.3) Pipe-work, electrical fittings, ventilation
openings and similar service lines shall be designed
and identified by colours and the nature of the supply
and direction of flow shall be indicated.
12. 4. ANCILLARY AREAS
4.1) Rest and refreshment rooms shall be separate
from other areas. Not lead directly to the manufacturing
and storage areas.
4.2) Facilities for changing, storing clothes and for
washing and toilet purposes shall be easily accessible
and adequate for the number of users.
4.3) Areas housing animals shall be isolated from
other areas.
13. 5. QUALITY CONTROL AREA
5.1) Quality-Control Laboratories shall be independent of the production areas.
Separate areas shall be provided each for physicochemical, biological,
microbiological or radio-isotope analysis and instrument room.
5.2) It must be adequate space shall be provided to avoid mix-ups and crosscontamination and provided for test samples, retained samples, reference standards,
reagents and records.
14. 6. PERSONNEL
6.1) The manufacture shall be conducted under the direct supervision of technical
staff with prescribed qualifications and practical experience.
6.2) The head of the QC Laboratory shall be independent of the manufacturing unit.
The testing shall be under technical staff.
6.3) Personnel for QA and QC operations shall be suitably qualified and
experienced.
15. 7. HEALTH CLOTHING AND
SANITATION OF WORKERS
7.1) The personnel handling potent drugs shall be
periodically examined for adverse effects. These
personnel should be moved out of these sections
(except in dedicated facilities) by rotation, as a health
safe guard.
7.2) All personnel shall undergo medical examination
including eye examination, and shall be free from
Tuberculosis, skin and other communicable diseases.
16. 7.3) No person showing, at any time apparent
illness or open lesions which may adversely affect
the quality of products shall be allowed to handle
starting materials packaging materials, in-process
materials, and drug products until his condition is
no longer judged to be a risk.
7.4) All employees shall be instructed to report
about their illness or abnormal health condition to
their immediate supervisor so that appropriate
action can he taken.
7.5) Smoking, eating, drinking, chewing or keeping
plants, food, drink and personal medicines shall not
be permitted in production. Laboratory storage and
other areas where they might adversely influence
the product quality.
17. 8. MANUFACTURING OPERATIONS AND
CONTROLS
8.1) All manufacturing operations shall he carried out
under the supervision of technical staff approved by
the Licensing Authority.
The contents of all vessels and containers used in
manufacture and storage during the various
manufacturing stages shall be name of the product,
batch no, batch size and stage of manufacture. Each
label should be signed and dated by the authorized
technical staff.
8.2)Environment shall be maintain at required level
of temp. , humidity and cleanliness.
18. 8.2 Precautions against mix-up
and cross-contamination
1) The drug material and drug product (from
environmental dust) by proper air handling system.
2) The processing of sensitive drugs like BetaLactum antibiotics, sex hormones and cytotoxic
substances is isolated production areas.
3)To prevent mix-up during production stages,
material under process shall he conspicuously
labelled to demonstrate their status.
19. 4) The packaging lines, printing machines, and
other equipment are clean and free from any
products, materials and spillages.
5)The manufacturing environment shall be
maintained at the required levels of temperature,
humidity and cleanliness.
6) Authorised persons shall ensure change-over into
specific
uniforms
before
undertaking
and
manufacturing operations including packaging.
20. 9. SANITATION IN THE MANUFACTURING
PREMISES
9.1) The manufacturing premises shall be cleaned and
maintained in an orderly manner, so that it is free from
accumulated waste, dust, debits and other similar material.
9.2) The manufacturing areas shall not be used for storage of
materials except for the material being processed, It shall not
he used as general thoroughfare.
9.3) A routine sanitation program shall be drawn up and
observe;
(a) specific was to be cleaned and cleaning intervals.
(b) cleaning procedure to be followed, including equipment
and materials to be used for cleaning, and
(c) personnel assigned to and responsible for the cleaning
operation.
21. 10. RAW MATERIALS
10.1)All incoming materials shall be immediately after receipt
or processing and stored under appropriate conditions .
10.2) Wherever possible, raw materials should be purchased
directly from the producers.
10.3) Authorised staff shall be check each container for
integrity of package and seal.
10.4) Labells shall be clearly marked with the following
information :
(a) designated name of the product and the internal code
reference, where applicable, and analytical reference number;
(b) manufacturer's name, address and batch number:
(c) the status of the contents (e.g. quarantine, under test,
released, approved, rejected):
(d) the manufacturing date, expiry date and re-test date.
22. 11. EQUIPMENTS
11.1) Equipment shall he located, designed, constructed,
adapted and maintained to suit the operations to be earned out.
11.2)Balances and other measuring equipment of an
appropriate range, accuracy and precision shall be available in
the raw-material stores.
11.3) To avoid accidental contamination and the equipment
shall be maintained in a way that lubricants do not contaminate
the products being produced.
11.4) Defective equipment shall be removed from production
and Quality Control areas or appropriately labelled.
23. 12. DOCUMENTATION AND RECORDS
Documentation is an essential part of the Quality
assurance system
and all materials, method of manufacture and control.
12.1) Documents designed, prepared, reviewed
controlled, wherever applicable, shall comply
these rules.
12.2) Documents shall be approved, signed
dated by appropriate and authorised persons.
12.3) Documents shall specify the title, nature
purpose.
and
with
and
and
24. MATERIALS
13. LABELS AND OTHER PRINTED
The label shall carry all the prescribed details about the product.
13.1) All containers and equipment shall hear appropriate
labels.
Different colour coded labels shall be used to indicate the status
of a product (for example under test, approved. passed,
rejected).
13.2)To avoid chance mix-up of printed packaging materials,
product leaflets, relating to different products, shall be stored
separately.
13.5) The label or document of reference standards and
reference culture shall medicate concentration, lot number,
potency, date on which container was first opened and storage
conditions, where appropriate.
25. 14. QUALITY ASSURANCE
14.1) The system of QA appropriate to the manufacture of
pharmaceutical products shall ensure that
(a) the pharmaceutical products are designed and developed
in away, that takes account of the requirements of GMP and
GLP and GCP.
(b) adequate arrangements are made for manufacture,
supply, and use of the correct starting and packaging materials.
(c) adequate controls on starting materials, intermediate
products, and hulk products and other in process controls ,
calibrations and validations arc carried out;
26. 15. SELF INSPECTION AND QUALITY AUDIT
It shall be drawn up which shall include the following:
a) Personnel.
b) Premises including personnel facilities.
c) Maintenance of buildings and equipment.
d) Storage of starting materials and finished products.
e) Equipment.
f) Production and in-process controls.
g) Quality control.
h) Documentation.
i) Sanitation and hygiene.
j) Validation and revalidation programmes.
k) Calibration of instruments or measurement systems.
l) Recall procedures.
m) Complaints management.
n) Labels control.
o) Results of previous self-inspections and any corrective steps taken
27. 16. QUALITY CONTROL SYSTEM
16.1) QC laboratory manned by qualified and experienced staff.
16.2) The area of the QC laboratory may be divided into
Chemical, Instrumentation Microbiological and Biological
testing.
16.3) Adequate area having the required storage conditions
shall be provided for keeping reference samples.
16.4) SOPs shall be available for sampling, inspecting, and
testing of raw materials, intermediate, bulk finished products
and packing materials and wherever necessary, for monitoring
environmental conditions.
16.5) There shall be authorized and dated specifications for all
materials, products, reagents and solvents including test of
identity, content, purity and quality.
28. 17. SPECIFICATIONS
17.1 For Raw materials and Packaging materials.
They shall include.
(a) the designated name and internal code reference;
(b) reference, if any, to a pharmacopoeia monograph;
(c) qualitative and quantitative requirements with acceptance
limits;
(d) name and address of manufacturer or supplier and original
manufacturer of the material;
(e) specimen of printed material;
(f) directions for sampling and testing or reference to
procedures;
(g) storage conditions; and
(h) maximum period of storage before re-testing.
29. 17.2 For product Containers and Closures
1)All containers and closures intended for use shall comply with
the Pharmacopoeia requirements. Suitable validated test
methods, sample sizes, specifications, cleaning procedure and
sterilisation procedure, shall be strictly followed.
2) Whenever bottles are being used, the written schedule of
cleaning. Where bottles are not dried after washing, they should
be rinsed with de-ionised water or distilled water as the case
may be.
17.3 For in process and bulk products.-
Specifications for in-process material. intermediate and bulk
products shall be available. The specifications should be
authenticated.
30. 17.4 For finished products:—
Appropriate specifications for finished products shall include
(a) the designated name of the product and the code
reference;
(b) the formula or a reference to the formula and the
pharmacopoeia reference:
(c) directions for sampling and testing or a reference to
procedures:
(d) a description of the dosage form and package details:
(e) the qualitative and quantitative requirements with the
acceptance limits for release:
(f) the storage conditions and precautions where applicable,
and
(g) the shelf-life.
31. 17.5 For preparation of containers and
closures.—
The requirements of machinery, equipments an
premises required for preparation of containers and
closures for different dosage forms and categories of
drugs.
The suitability and adequacy of the machinery,
equipment and premises shall be examined taking into
consideration the requirements of each licensee in this
respect.
32. 18. MASTER FORMULA RECORDS
The Master Formula shall include,
(a) the name of the product together with product
reference code relating to its specifications:
(b) the name of the product along with the generic
name, a description of the dosage form, strength,
composition of the product and batch size:
(c) name, quantity, and reference number of all the
starting materials to be used.
(d) a statement of the expected final yield with the
acceptable limits, and of relevant intermediate yields,
where applicable:
(e) a statement of the processing location and the
principal equipment to he used:
33. (f) The methods or reference to the methods, to be
used for preparing the critical equipment including
cleaning, assembling, calibrating, sterilizing:
(g) detailed stepwise processing instructions and the
time taken for each step;
(h) the instructions for in-process controls with their
limits;
(i) the requirements for storage conditions of the
products, including the container, labelling and
special storage conditions where applicable;
(j) any special precautions to be observed;
(k) packing details and specimen labels.
34. 19. PACKAGING RECORDS
(a) name of the product;
(b) description of the dosage form, strength and
composition;
(c) the pack size expressed in terms of the number or
doses, weight or volume of the product in the final
container;
(d) complete list of all the packaging materials
required for a standard batch size, including
quantities, sizes and types, with the code or reference
number relating to the specifications of each
packaging material;
35. (e) the printed packaging materials indicating where
batch number and expiry date of the product have
been applied;
(f) description of the packaging operation, including
any significant subsidiary operations and equipment
to be used;
(h) details of in-process controls with instructions for
sampling and acceptance;
(i) completion of the packing and labelling operation
shall be made between number of labelling and
packaging units issued, number of units labelled,
packed and excess returned or destroyed.
36. 20. BATCH PACKAGING RECORDS
1) A batch packaging record shall he kept for each
batch or part batch processed.
2) Before any packaging operations begins, check
shall be made and recorded that the equipment and
the work stations are clear of the previous products,
and that the equipment is clean and suitable for use.
37. 21. BATCH PROCESSING RECORDS
1) There shall be Batch processing Record for each
product. It shall be based on the relevant parts of the
currently approved Master Formula.
2) Before any processing , check be performed and
recorded to ensure that the equipment and work station
are clear of previous Products.
3) During processing the person responsible for these
operations:
a) the name of the product.
b) the number of the batch being manufactured,
38. c) dates and time of commencement, of significant
intermediate stages and of completion of production.
d) Initials of the operator of different significant
steps of production and where appropriate, of the
person who checked each of these operations,
e) the batch number and/or analytical control
number as well as the quantities of each starting
material actually weighed.
f) any relevant processing operation or event and
major equipment used,
g) a record of the in-process controls and the
initials of the person(s) carrying them out, and the
results obtained.
39. h) the amount of product obtained after different and
critical stages of manufacture (yield).
i) comments or explanations for significant deviations
from the expected yield limits shall be given,
j) notes on special problems -including details, with
signed authorization, for any deviation from the master
formula,
k) addition of any recovered or reprocessed material
with reference to recovery or reprocessing stages.
40. 22. STANDARD OPERATING
PROCEDURES (SOPS)
AND RECORDS,
REGARDING
22.1 Receipt of Materials.
1) There shall be written SOPS and records for the
receipt of each delivery of raw, primary and printed
packaging material.
2) The records of the receipts shall include,
(a) the name of the material on the delivery note and
the number of
the containers:
(b) the date of receipt:
(c) the manufacturer's and/or supplier's name:
41. (d) the manufacturers batch or reference number:
(e) the total quantity. and number of containers,
quantity in each
container received:
(f) the control reference number assigned after
receipt:
(g) any other relevant comment or information.
3) There shall be written SOPS for the internal
labelling quarantine and storage of starting materials,
packaging materials and other materials, as
appropriate and instrument and equipment.
42. 22.2 Sampling
1) The sampling instructions shall include
(a) the method of sampling and the sampling plan,
(b) the equipment to be used,
(c) any precautions to he observed to avoid
contamination of the material or any deterioration in its
equality,
43. (d) the quantity of samples to be taken.
(e) instructions for any required sub-division or
pooling of the samples,
(f) the type of sample container to be used,
(g) any specific precautions to be observed,
especially in regard to sampling of sterile or
hazardous material.
44. 22.3 Batch Numbering
1) There shall be SOPS describing the details of the
batch (lot) numbering set and bulk or finished product
is identified with a specific batch number.
2) Batch numbering SOPS applied to a processing
stage and to the respective packaging stage.
3) Batch number allocation shall be immediately
recorded in a logbook or by electronic data processing
system.
45. 22.4 Testing
There shall be written procedures for testing
materials and products at different stages of
manufacture, describing the methods and
equipment to he used. The tests performed
shall be recorded.
46. 22.5 Records of analysis
1) The records shall include following data:
(a) name of the material or product and the dosage
form,
(b) batch number and, manufacturer
(c) specifications and testing procedures,
(d) test results, observations and calculations
(e) dates of testing,
(f) initials of the persons who performed the testing,
(g) initials of the persons who verified the testing and
the detailed calculations.
(h) signature and date of the designated responsible
person.
47. 2) There shall he written SOPS and the associated
records of actions taken for:a) equipment assembly and validation;
b) analytical apparatus and calibration:
c) maintenance, cleaning and sanitation:
d) personnel matters including qualification, training.
clothing hygiene;
e) environmental monitoring:
f) pest control;
g) complaints;
h) recalls made;
i) returns received.
48. 23. REFERENCE SAMPLES
1) In a quantity sufficient to carry out all the
tests except sterility and pyrogen ,Bacterial
Endotoxin. Test shall be retained for a period of
3 months after the date of expiry of the last
batch produced from that active ingredient.
2) Samples of finished formulations shall be
stored in the same or simulated containers in
which the drug has been actually marketed.
49. 24. REPROCESSING AND
RECOVERY
1)written procedures shall be established and
approved by the Quality Assurance Department
that shall specify the conditions and limitations of
repeating chemical reactions.
2)If the product batch has to be reprocessed, the
procedure shall be authorised and recorded. Reprocessed batch shall be subjected to stability
evaluation.
3) Recovery of product residue may be carried out,
if permitted, in the master production and control
records by incorporating it in subsequent batches
of the product.
50. 25. DISTRIBUTION RECORDS
1) Prior to distribution or dispatch of given batch of a
drug, it shall be ensured that the batch has been daily
tested, approved and 'released 'by the quality control
personnel.
2) Records for distribution shall be maintained in a
manner such that finished batch of a drug can be
traced to the retail level to facilitate and complete
recall of the batch, if and when necessary.
51. 26. VALIDATION AND
PROCESS VALIDATION
1) Validation studies shall be an essential part of GMP
and shall be conducted as per the pre-defined
protocols. These shall include validation of processing,
testing and cleaning procedures.
2) A written report summarising recorded results and
conclusions shall be prepared, documented and
maintained.
52. 3) Processes and procedures shall be established on
the basis of validation study and undergo periodic
revalidation to ensure that they remain capable of
achieving the intended results.
4) When any new master formula or method of
preparation is adopted, steps shall be taken to
demonstrate its suitability for routine processing.
5) Significant changes to the manufacturing process,
including any
change in equipment or materials that may affect
product quality and / or
the reproducibility of the process, shall be validated.
53. 27. COMPLAINTS AND ADVERSE
REACTIONS
1) Each complaint shall be investigated evaluated by the
designated personnel of the company and records of
investigation and remedial action taken thereof shall be
maintained.
2) Reports of serious adverse drug reactions resulting from the
use of a drug along with comments and documents shall be
reported to the concerned Licensing Authority.
3) There shall be written procedures describing the action to be
taken, recall to be made of the defective product.
54. 29. SITE MASTER FILE
The Site Master File containing specific and GMP about the
production and control of pharmaceutical manufacturing
preparations carried out at the licensed premises. It shall contain
the following:-
29.1 General information
(a) brief information of the firm;
(b) pharmaceutical manufacturing activities as permitted by the
licensing authority:
(c) Type of products licensed for manufacture with flowcharts
mentioning procedures and process flow;
55. (d) number of employees engaged in the production,
quality controls storage and distribution;
(e) use of outside scientific, analytical or other
technical assistance in relation to manufacture and
analysis;
(f) select description of the Quality Management
system of the firm;
(g) products details registered with foreign
countries.
56. 29.2 Personnel
(a) organisational chart showing the arrangement for
quality assurance including production and quality
control:
(b) qualification, experience and responsibilities of
key personnel:
(c) health requirements for personal engaged in
production;
(d) personnel hygiene requirements, including
clothing.
57. 29.3 Premises
(a) simple plan or description of manufacturing areas
drawn to scale.
(b) nature of construction and fittings;
(c) brief description of ventilation systems.
(d) special areas for the handling of the highly toxic,
hazardous and sensitising materials.
(e) brief description of water systems (schematic
drawings of systems), including sanitation.
58. 29.4 Equipment
a)Brief description of major equipment used in
production and quality control laboratories (a list of
equipment required):
b)Description of planned preventive maintenance
programs for equipment and of the recording system:
(c)Qualification and calibration, including the
recording systems and arrangements for computerised
systems validation.
59. 29.5 Sanitation
(a) availability of written specifications and
procedures for cleaning manufacturing areas and
equipment.
29.6 Documentation
(a) arrangements for the preparation. revision and
distribution.
(b) necessary documentation for the manufacture.
(c) any other documentation related to product
quality that is not mentioned where (e.g..
microbiological controls about air and
water).
60. 29.7 Production
(a)
production operations using, flow sheets and
charts specifying important parameters;
(b) arrangements for the handling of starting materials,
packaging materials, bulk and finished products,
including sampling, quarantine, release and storage:
(c) arrangements for the handling of rejected materials
and products:
(d) brief description of general policy for process
validation.
61. 29.8 Quality control
Description of the quality control system and of the activities of
the quality control department. Procedures for the release of the
finished products.
29.9 Loan licence manufacture and licensee
Description of the way in which compliance of Good
Manufacturing Practices by the loan licensee shall be assessed.
29.10 Distribution, complaints and product recall
(a) arrangements and recording system for distribution;
(b) arrangements for the handling of complaints and product
recalls.
62. 29.11 Self-Inspection
short description of the self-inspection system
indicating whether an outside, independent and
experienced external expert was involved in evaluating
the
manufacturer's
compliance
with
Good
Manufacturing Practices in all aspects of production.
29.12 Export of drugs
(a) products exported to different countries: