Quality of drugs is basically responsibility of manufacturers & GMP guidelines are a means to assure very quality.
Draft of GMP regulations was prepared in 1975 which could be finalized & implemented in 1988, in form of amended schedule M.
It embraces Rule 71,74,76 & 78 under D & C Rules 1945.
To achieve objectives of GMP, licensee shall comply with requirements of GMP as laid down in Schedule M.
Part I deals with GMP relating to factory premises, & Part II deals with plant & equipment for manufacture of drugs.
The document discusses the responsibilities of a production pharmacist at a pharmaceutical company in Bangladesh. It lists the pharmacist's duties which include coordinating manufacturing processes, ensuring compliance with cGMP regulations, controlling production areas and equipment, supervising staff, and preparing daily reports. It also describes several types of machines used in pharmaceutical production, such as capsule filling machines, rotary tablet presses, liquid filling machines, and packaging equipment.
The document provides an overview of Good Manufacturing Practices (GMP). It discusses that GMPs are procedures and universal steps that provide basic environmental conditions and management systems necessary for safe food production. It outlines 10 key areas of GMP including facilities, equipment, water supply, waste disposal, cleaning, and personnel practices. The document emphasizes that GMPs focus on preventative measures and each facility must implement supervision and monitoring systems to ensure food safety.
Quality assurance and good manufacturing practices are important to ensure drug quality and safety. Quality assurance covers all factors that influence a product's quality and requires adequate resources. Good manufacturing practices provide quality standards for production and controls to ensure products meet their intended use as required by regulations. Key elements of good manufacturing practices include facilities, equipment, documentation, materials management, production controls, packaging and labeling, storage, and validation. While GMPs vary between countries, the overall goals are similar in requiring design and maintenance standards, standard operating procedures, quality control, trained personnel, and management oversight.
Quality audits involve the systematic and independent examination of quality activities and processes to determine compliance with established standards. They can be internal or external. The presented document discusses the definition, purpose, types, procedures, and important aspects of quality audits for pharmaceutical companies. It provides an overview of audit planning, conducting audits, common difficulties found, and essential features of audit reports. The goal is to evaluate procedures, records, and operations to ensure they meet quality goals and identify any non-compliances or deficiencies.
The document discusses implementing a holistic quality management system (QMS) by redefining corrective and preventive action (CAPA). It outlines challenges with traditional QMS approaches and regulations from ISO, FDA, and the European Commission regarding CAPA. The document recommends treating any opportunity to improve quality as a CAPA, and that CAPAs should follow a process from identifying problems to verifying the effectiveness of corrective actions.
The pharmaceutical Quality by Design is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. Quality by Design is emerging to enhance the assurance of safe, effective drug supply to the consumer, and also offers promise to significantly improve manufacturing quality performance
The document discusses the responsibilities of a production pharmacist at a pharmaceutical company in Bangladesh. It lists the pharmacist's duties which include coordinating manufacturing processes, ensuring compliance with cGMP regulations, controlling production areas and equipment, supervising staff, and preparing daily reports. It also describes several types of machines used in pharmaceutical production, such as capsule filling machines, rotary tablet presses, liquid filling machines, and packaging equipment.
The document provides an overview of Good Manufacturing Practices (GMP). It discusses that GMPs are procedures and universal steps that provide basic environmental conditions and management systems necessary for safe food production. It outlines 10 key areas of GMP including facilities, equipment, water supply, waste disposal, cleaning, and personnel practices. The document emphasizes that GMPs focus on preventative measures and each facility must implement supervision and monitoring systems to ensure food safety.
Quality assurance and good manufacturing practices are important to ensure drug quality and safety. Quality assurance covers all factors that influence a product's quality and requires adequate resources. Good manufacturing practices provide quality standards for production and controls to ensure products meet their intended use as required by regulations. Key elements of good manufacturing practices include facilities, equipment, documentation, materials management, production controls, packaging and labeling, storage, and validation. While GMPs vary between countries, the overall goals are similar in requiring design and maintenance standards, standard operating procedures, quality control, trained personnel, and management oversight.
Quality audits involve the systematic and independent examination of quality activities and processes to determine compliance with established standards. They can be internal or external. The presented document discusses the definition, purpose, types, procedures, and important aspects of quality audits for pharmaceutical companies. It provides an overview of audit planning, conducting audits, common difficulties found, and essential features of audit reports. The goal is to evaluate procedures, records, and operations to ensure they meet quality goals and identify any non-compliances or deficiencies.
The document discusses implementing a holistic quality management system (QMS) by redefining corrective and preventive action (CAPA). It outlines challenges with traditional QMS approaches and regulations from ISO, FDA, and the European Commission regarding CAPA. The document recommends treating any opportunity to improve quality as a CAPA, and that CAPAs should follow a process from identifying problems to verifying the effectiveness of corrective actions.
The pharmaceutical Quality by Design is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. Quality by Design is emerging to enhance the assurance of safe, effective drug supply to the consumer, and also offers promise to significantly improve manufacturing quality performance
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.
When designing a pharmaceutical manufacturing facility, the ways in which materials are moved from one stage of production to another should be considered from the very beginning. so the drug industry location and design considered crucial and should be according to GMP standards.
This document discusses different types of quality audits, including internal audits conducted by a company to ensure quality standards are met, external audits conducted by outside parties to ensure standards are met for suppliers or customers, and different focused audits like process, product, and system audits. It also outlines the audit process and how to prepare for an audit by having the proper documentation in place like protocols, consent forms, safety reports, agreements, personnel records, case report forms, and source data.
A quality audit, also known as a quality assurance audit or compliance audit, is a systematic examination and evaluation of processes, systems, and records to determine compliance with established quality standards, regulations, guidelines, and best practices. The purpose of a quality audit is to identify areas of non-compliance, assess the effectiveness of quality management systems, and identify opportunities for improvement. Here are some key aspects of a quality audit
This document discusses technology transfer in the pharmaceutical industry. It begins with an introduction and overview, then discusses the basic concepts and stages of technology transfer. The key stages are research, development, and production. Technology transfer is important for upgrading drug quality during manufacturing and ensuring quality is maintained between different production sites. Effective communication between all stakeholders is key to the successful transfer of technology.
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 guidelines on pharmaceutical development as described in ICH Q8(R2). It discusses the objective to design a quality product and manufacturing process. Key points covered include critical quality attributes, design space, control strategies, flexibility opportunities, and examples of QbD application. The annex to ICH Q8(R1) further explains quality by design principles and their application in practice.
ISO establishes voluntary international standards to ensure quality, safety, and efficiency. ISO's most popular standards are ISO 9001 for quality management, ISO 14001 for environmental management, and ISO/IEC 27001 for information security. ISO 9001 focuses on meeting customer needs and continual improvement. ISO 14001 focuses on minimizing environmental impacts and conforming to regulations. Certification to ISO standards is done by independent auditors and provides benefits like improved operations, customer satisfaction, and international trade compliance.
1. The document discusses qualitative and quantitative models of technology transfer. Qualitative models delineate activities and factors that influence success, while quantitative models aim to quantify parameters and minimize incompatibility between transferors and transferees.
2. Several qualitative models are described, including the Bar-Zakay, Behrman and Wallender, Dahlman and Westphal, and Schlie, Radnor and Wad models. These models outline stages of the technology transfer process and factors that influence effectiveness.
3. Quantitative models discussed aim to measure parameters like potential technological distance between transferors and transferees, and examine the technological "catch-up" process when a leader assists a follower.
This document outlines a procedure for change control at an organization. It defines change control as a quality tool to maintain records of all changes as a history. Changes can relate to facilities, documentation, systems, equipment, instruments, procedures, layouts, and products. Changes are categorized as minor, major, or critical based on their impact. The change control process involves initiating a change, getting approvals from relevant departments, implementing the change, reviewing and closing out the change control. A numbering system is used to track changes and all records are maintained by the quality assurance department.
The quality assurance department in the pharmaceutical industry plays a key role in ensuring product quality and safety. It maintains oversight of production, quality control, warehousing, and facilities to ensure compliance with good manufacturing practices. The department is independent from production to provide unbiased quality monitoring. It utilizes tools like investigations, root cause analysis, change management, and quality reviews to continuously improve quality assurance. The overall goal is to protect public health by guaranteeing that medicines meet appropriate standards of identity, strength, purity and quality.
This document provides an overview of a quality systems approach. It discusses key elements like design controls, production and process controls, corrective and preventive actions, management reviews, and continuous improvement. The quality system aims to design quality in from the beginning, execute according to design, and monitor and control through quality assurance. It also discusses applying this approach to pharmaceutical development and manufacturing through concepts like an integrated validation master plan and quality evaluations.
This document provides an overview of Good Manufacturing Practices (GMP) for pharmaceutical manufacturing. It defines GMP as ensuring products are consistently manufactured and controlled to quality standards for their intended use. The document outlines key aspects of GMP, including facilities and equipment qualification, training, documentation, production and process controls, packaging and labeling, quality testing, and distribution. It explains that GMP is important for producing safe, effective drugs and minimizing risks that cannot be detected through final testing alone. International GMP guidelines from organizations like WHO, FDA, and ICH are also referenced.
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.
This document discusses vendor audits for packaging materials. It defines a vendor audit as a way for pharmaceutical companies to inspect and evaluate a vendor's quality management system and practices. The objectives of a vendor audit are to ensure contracts are executed properly and identify risks, cost savings, and process improvements. The document outlines key steps in conducting a vendor audit, including preparing an audit plan, inspecting facilities and documentation, and writing an evaluation report. It also provides details on auditing packaging material vendors, such as checking storage areas, materials, and supplier qualifications.
This document provides a case study on the pharmaceutical development of acetriptan tablets (ACE tablets). It summarizes the formulation and manufacturing process selection, including the selection of drug substance and excipients. It then describes the formulation development work to select a prototype formulation and process, including component level definition studies and process optimization studies. It also describes the manufacturing process development, including optimization of blending, roller compaction, lubrication, and tablet compression unit operations. Finally, it discusses the clinical pharmacokinetic study, in vitro-in vivo correlation, control strategy, and specifications for the ACE tablet drug product.
This document discusses the rules for charging components into pharmaceutical manufacturing batches according to CFR 211.101. It states that production procedures must ensure drug products have the labeled identity, strength, quality and purity. Components must be weighed, measured or subdivided as specified. Any container a component is removed to must be labeled with identification information. Weighing operations require adequate supervision and a second check of released components, weights and container labels. Automated equipment may only require one person if it meets certain requirements.
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.
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.
When designing a pharmaceutical manufacturing facility, the ways in which materials are moved from one stage of production to another should be considered from the very beginning. so the drug industry location and design considered crucial and should be according to GMP standards.
This document discusses different types of quality audits, including internal audits conducted by a company to ensure quality standards are met, external audits conducted by outside parties to ensure standards are met for suppliers or customers, and different focused audits like process, product, and system audits. It also outlines the audit process and how to prepare for an audit by having the proper documentation in place like protocols, consent forms, safety reports, agreements, personnel records, case report forms, and source data.
A quality audit, also known as a quality assurance audit or compliance audit, is a systematic examination and evaluation of processes, systems, and records to determine compliance with established quality standards, regulations, guidelines, and best practices. The purpose of a quality audit is to identify areas of non-compliance, assess the effectiveness of quality management systems, and identify opportunities for improvement. Here are some key aspects of a quality audit
This document discusses technology transfer in the pharmaceutical industry. It begins with an introduction and overview, then discusses the basic concepts and stages of technology transfer. The key stages are research, development, and production. Technology transfer is important for upgrading drug quality during manufacturing and ensuring quality is maintained between different production sites. Effective communication between all stakeholders is key to the successful transfer of technology.
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 guidelines on pharmaceutical development as described in ICH Q8(R2). It discusses the objective to design a quality product and manufacturing process. Key points covered include critical quality attributes, design space, control strategies, flexibility opportunities, and examples of QbD application. The annex to ICH Q8(R1) further explains quality by design principles and their application in practice.
ISO establishes voluntary international standards to ensure quality, safety, and efficiency. ISO's most popular standards are ISO 9001 for quality management, ISO 14001 for environmental management, and ISO/IEC 27001 for information security. ISO 9001 focuses on meeting customer needs and continual improvement. ISO 14001 focuses on minimizing environmental impacts and conforming to regulations. Certification to ISO standards is done by independent auditors and provides benefits like improved operations, customer satisfaction, and international trade compliance.
1. The document discusses qualitative and quantitative models of technology transfer. Qualitative models delineate activities and factors that influence success, while quantitative models aim to quantify parameters and minimize incompatibility between transferors and transferees.
2. Several qualitative models are described, including the Bar-Zakay, Behrman and Wallender, Dahlman and Westphal, and Schlie, Radnor and Wad models. These models outline stages of the technology transfer process and factors that influence effectiveness.
3. Quantitative models discussed aim to measure parameters like potential technological distance between transferors and transferees, and examine the technological "catch-up" process when a leader assists a follower.
This document outlines a procedure for change control at an organization. It defines change control as a quality tool to maintain records of all changes as a history. Changes can relate to facilities, documentation, systems, equipment, instruments, procedures, layouts, and products. Changes are categorized as minor, major, or critical based on their impact. The change control process involves initiating a change, getting approvals from relevant departments, implementing the change, reviewing and closing out the change control. A numbering system is used to track changes and all records are maintained by the quality assurance department.
The quality assurance department in the pharmaceutical industry plays a key role in ensuring product quality and safety. It maintains oversight of production, quality control, warehousing, and facilities to ensure compliance with good manufacturing practices. The department is independent from production to provide unbiased quality monitoring. It utilizes tools like investigations, root cause analysis, change management, and quality reviews to continuously improve quality assurance. The overall goal is to protect public health by guaranteeing that medicines meet appropriate standards of identity, strength, purity and quality.
This document provides an overview of a quality systems approach. It discusses key elements like design controls, production and process controls, corrective and preventive actions, management reviews, and continuous improvement. The quality system aims to design quality in from the beginning, execute according to design, and monitor and control through quality assurance. It also discusses applying this approach to pharmaceutical development and manufacturing through concepts like an integrated validation master plan and quality evaluations.
This document provides an overview of Good Manufacturing Practices (GMP) for pharmaceutical manufacturing. It defines GMP as ensuring products are consistently manufactured and controlled to quality standards for their intended use. The document outlines key aspects of GMP, including facilities and equipment qualification, training, documentation, production and process controls, packaging and labeling, quality testing, and distribution. It explains that GMP is important for producing safe, effective drugs and minimizing risks that cannot be detected through final testing alone. International GMP guidelines from organizations like WHO, FDA, and ICH are also referenced.
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.
This document discusses vendor audits for packaging materials. It defines a vendor audit as a way for pharmaceutical companies to inspect and evaluate a vendor's quality management system and practices. The objectives of a vendor audit are to ensure contracts are executed properly and identify risks, cost savings, and process improvements. The document outlines key steps in conducting a vendor audit, including preparing an audit plan, inspecting facilities and documentation, and writing an evaluation report. It also provides details on auditing packaging material vendors, such as checking storage areas, materials, and supplier qualifications.
This document provides a case study on the pharmaceutical development of acetriptan tablets (ACE tablets). It summarizes the formulation and manufacturing process selection, including the selection of drug substance and excipients. It then describes the formulation development work to select a prototype formulation and process, including component level definition studies and process optimization studies. It also describes the manufacturing process development, including optimization of blending, roller compaction, lubrication, and tablet compression unit operations. Finally, it discusses the clinical pharmacokinetic study, in vitro-in vivo correlation, control strategy, and specifications for the ACE tablet drug product.
This document discusses the rules for charging components into pharmaceutical manufacturing batches according to CFR 211.101. It states that production procedures must ensure drug products have the labeled identity, strength, quality and purity. Components must be weighed, measured or subdivided as specified. Any container a component is removed to must be labeled with identification information. Weighing operations require adequate supervision and a second check of released components, weights and container labels. Automated equipment may only require one person if it meets certain requirements.
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 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.
The document outlines good manufacturing practices (GMP) that must be followed to produce safe products. It discusses personnel hygiene practices, facility requirements, storage practices, process equipment guidelines, cleaning and sanitation procedures, pest control measures, and documentation standards that are necessary to ensure product quality and safety.
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.
Communication and motivational initiatives by Roberto DanielRoberto Daniel
Roberto implements various communication and motivational initiatives at the factory including monthly town hall meetings to share metrics and celebrate achievements. Employees who suggest improvements or reach milestones are recognized with diamond cards worth points that can be redeemed for gifts. Roberto also aims to improve management-employee integration through activities like coffee meetings with employees drawn from a lottery and shadowing Roberto for a day.
This document outlines the requirements for factory premises manufacturing medical devices according to Schedule M-III of the Drugs and Cosmetics Rules 1945 in India. It discusses location, building, water supply, waste disposal, worker hygiene and medical facilities requirements. It also provides recommendations for equipment and space needed for manufacturing common medical devices like perfusion sets, syringes and needles. Manufacturers must follow good manufacturing practices and maintain processing and quality control records. Medical devices are classified based on risk into four classes from low to high risk.
The document discusses ICH Q7 guidelines for good manufacturing practices for active pharmaceutical ingredients. ICH Q7 provides guidance on GMP for manufacturing APIs to ensure quality, safety and efficacy. It covers requirements for facilities, equipment, documentation, materials management, production, packaging, labeling, testing, validation, and quality management. Adhering to ICH Q7 helps ensure consistent API quality and reduces batch variations.
The document discusses moving an organization from good to great. It outlines several key concepts from the book "Good to Great" for doing so, including having level 5 leadership, confronting brutal facts, developing a hedgehog concept, establishing a culture of discipline, and using technology accelerators. It emphasizes the importance of first getting the right people on the bus before deciding what to do, and how achieving greatness is more like pushing a heavy flywheel forward through consistent, small efforts over time rather than any single defining action.
This document outlines the duties and responsibilities of food inspectors in India. It details that food inspectors are tasked with regularly inspecting all food establishments to ensure they comply with licensing conditions. They are also responsible for collecting food samples if contamination is suspected, investigating complaints, maintaining inspection records, detecting illegal food operations, stopping vehicles with suspect food, and detaining imported food shipments if necessary. The document also specifies the forms inspectors must use for orders, receipts, notices, and warranties.
Quality assurance audits in pharma industries rasika walunj
Quality audits are systematic examinations to determine if activities comply with plans and regulations. Pharmaceutical manufacturers use audits to verify compliance with Good Manufacturing Practices (GMP). Audits have two goals - to verify manufacturing systems are controlled and to permit timely problem correction. Audits evaluate GMP compliance in production and quality control. They are performed routinely and in cases like recalls. Areas audited include personnel, facilities, equipment, production, quality control, documentation, and more. Audits are classified as internal, external, or regulatory. Internal audits ensure quality systems and identify pre-inspection problems. External audits reduce risk for partners. Regulatory audits build cooperation between authorities. Effective auditing requires qualified staff, documentation,
The Consumer Protection Act 1986 was enacted to protect the rights of consumers in India. It protects the rights to safe goods, fair trade practices, consumer education, and redressal against unfair exploitation. The Act defines key terms like complaints, defects, deficiency, and establishes consumer forums at the district, state and national level to address consumer disputes and complaints against businesses and service providers. It also outlines what constitutes a consumer, unfair trade practices, restrictive trade practices, and the scope of consumer protection under this legislation.
The document discusses various provisions related to health, safety and welfare under the Factories Act of 1948 in India. It outlines requirements for cleanliness, ventilation, lighting, drinking water, sanitation facilities, and first aid in factories. It also covers provisions for washing facilities, clothing storage, seating, canteens, and shelters/rest rooms. The Act defines a factory and sets rules for maintaining clean and hygienic conditions, proper disposal of waste, adequate ventilation, protection from dust and fumes, and prevention of overcrowding in workplaces.
The document summarizes key aspects of the Consumer Protection Act 1986 in India. It defines important terms like goods, services, and consumers. It describes the objectives of the act to better protect consumer interests and rights. It outlines the consumer disputes redressal system including district forums, state commissions, and a national commission to provide speedy and inexpensive resolution of consumer complaints. It details the composition and jurisdiction of these quasi-judicial bodies. The summary aims to highlight the essential information around definitions, objectives, and dispute resolution mechanisms under the Act.
This document provides information about Easyfun company and its factory. The company is located in Shenzhen and has a factory in Jiangxi province that handles production. The factory was founded in 2005 and has 6 production lines with a monthly capacity of 450,000 units. It produces hair straighteners, brush irons, hair dryers, and curling irons. Hair straighteners make up 50% of production while brush irons and hair dryers each make up around 25% and 15% respectively. The remaining 10% is curling irons.
This document discusses the role of nanoparticles in drug delivery. Nanoparticles can enhance drug delivery by allowing targeted delivery and controlled release of drugs. They interact more efficiently with cells and require lower dosages, reducing side effects. Various types of nanoparticles used for drug delivery include metal-based, lipid-based, and polymer-based nanoparticles. Nanoparticles must be optimally designed to avoid rapid clearance from the body and target delivery to specific sites. Continued improvements in controlled release and targeting will enable safer and more effective therapeutic nanoparticles.
Liposomes are spherical vesicles composed of phospholipid bilayers that can encapsulate water-soluble drugs in their aqueous core and lipid-soluble drugs within their membrane. They have advantages for drug delivery such as providing selective targeting to tissues, increasing drug efficacy and stability, and reducing toxicity. However, they also have challenges with drug leakage and uptake by the reticuloendothelial system. Liposomes can be classified based on their lamellarity and size, and are prepared using methods like film hydration, ethanol injection, and detergent removal. They have applications for delivery of drugs, genes, vaccines, and contrast agents for imaging.
The document summarizes ICH Q10, which provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product. It describes the contents and sections of ICH Q10, including management responsibility, continual improvement of process performance and product quality, and continual improvement of the pharmaceutical quality system. The goal is to establish an effective quality management system for the pharmaceutical industry and enhance the quality and availability of medicines.
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.
This document provides information on current good manufacturing practices (CGMP) regulations enforced by the FDA to ensure quality in pharmaceutical manufacturing. It discusses the importance of CGMP for quality products, customer satisfaction, consistency and company reputation. The objectives are to understand regulatory requirements and minimize risks that can't be detected by final testing. The document outlines various CGMP guidelines related to facilities, equipment, personnel, documentation, batch records, quality control and more. It provides details on specific areas like premises, warehousing, water systems, waste disposal, production areas and equipment cleaning/validation.
This document provides an overview of requirements for Good Manufacturing Practices (GMP), Current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), USFDA guidelines, and ISO 9000 standards. It discusses key elements of GMP/cGMP including facilities, equipment, documentation, quality control, and compliance. It also outlines 10 key principles of GLP relating to test facility organization, quality assurance, facilities, equipment, test systems, substances, standard operating procedures, performance, reporting and record keeping. The document is intended to present information on regulatory standards for pharmaceutical manufacturing and laboratory testing.
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.
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.
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.
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.
This document provides an overview of Good Manufacturing Practices (GMP) in the pharmaceutical industry. It defines GMP and discusses why GMP is important to ensure consistent quality products and protect consumer safety. The document outlines the key principles of GMP, including facilities and equipment design, validation, documentation, quality control systems, and self-inspection. It also reviews specific GMP requirements for premises, equipment, raw materials, production, sanitation, quality audits, and more. Adhering to GMP regulations helps pharmaceutical manufacturers minimize risks and ensure their products are safe, pure, and effective.
This document discusses procedures for cleaning validation. It addresses:
- Cleaning procedures need validation for product contact surfaces and consideration for non-contact parts with potential for product migration.
- The objective is to provide evidence that cleaning procedures can effectively remove residues to a level that does not raise patient safety concerns.
- It describes strategies for validating cleaning of product contact surfaces after product changes, between batches, and periodically. Validation protocols and reports are outlined. Standard operating procedures for cleaning procedures are also addressed.
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.
This document defines Good Manufacturing Practice (GMP) and outlines its history and key regulations. GMP is a set of guidelines for ensuring products are consistently produced and controlled according to quality standards for their intended use. Major developments include the 1962 Thalidomide tragedy leading to GMP regulations, and guidelines published by organizations like WHO, FDA, and other national regulatory agencies. The document describes key aspects of GMP including facilities, equipment, production processes, packaging and labeling, quality control, and record keeping.
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.
Schedule M outlines Good Manufacturing Practices (GMP) that must be followed by pharmaceutical manufacturing units in India. It contains requirements for factory premises, plants, equipment, and quality assurance to ensure products are consistently manufactured and controlled to quality standards. Schedule M has two parts - Part 1 covers GMP for premises and materials, and Part 2 covers specific plant and material requirements. It provides detailed guidelines for facilities, equipment, sanitation, personnel, documentation, manufacturing, quality control, distribution, and more to help ensure therapeutic goods produced meet the required quality standards.
This document discusses Good Manufacturing Practices (GMP) for pharmaceutical manufacturing. It begins with an overview of why GMP is important for ensuring consistent quality and safety of medicines. It then outlines the key principles of GMP, including requirements for facilities, equipment, documentation, personnel, sanitation, and quality control. The document provides details on specific GMP requirements for premises, materials, production areas, equipment, packaging, batch records, and quality assurance systems. It also discusses self-inspection and quality auditing.
IMMUNOLOGY (for medical student) pharmacy departmentSlientNight
This document outlines guidelines for good manufacturing practices (GMP) to control microbial contamination during pharmaceutical production. It discusses performing risk assessments and maintaining environmental cleanliness. Starting materials must meet quality standards and water quality must be controlled. Strict quality control, documentation, packaging, and storage procedures are required. Facilities for sterile production must be properly designed, cleaned, and maintained in aseptic clean rooms with appropriate air handling. Regulatory authorities require GMP compliance for pharmaceutical licenses.
This document provides an overview of Beyond A Century, Inc.'s (BAC) current good manufacturing practices (GMP) program for packaging, labeling, and holding dietary supplements. It describes BAC's personnel requirements and training, facility design and maintenance, production and process controls, quality control testing, and Hazard Analysis and Critical Control Point (HACCP) plan. The HACCP plan identifies potential biological, chemical, and physical hazards at critical control points during receiving, sampling, storage, production, and shipping. It establishes monitoring, corrective actions, verification, and documentation procedures to control these hazards and prevent product adulteration.
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
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.
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.
3. Quality of drugs is basically responsibility ofQuality of drugs is basically responsibility of
manufacturers & GMP guidelines are a means tomanufacturers & GMP guidelines are a means to
assure very quality.assure very quality.
Draft of GMP regulations was prepared in 1975Draft of GMP regulations was prepared in 1975
which could be finalized & implemented in 1988,which could be finalized & implemented in 1988,
in form of amended schedule M.in form of amended schedule M.
It embraces Rule 71,74,76 & 78 under D & CIt embraces Rule 71,74,76 & 78 under D & C
Rules 1945.Rules 1945.
To achieve objectives of GMP, licensee shallTo achieve objectives of GMP, licensee shall
comply with requirements of GMP as laid down incomply with requirements of GMP as laid down in
Schedule M.Schedule M.
Licensee shall evolve methodology & proceduresLicensee shall evolve methodology & procedures
which should be documented & kept forwhich should be documented & kept for 33
4. reference & inspection.reference & inspection.
Part I deals with GMP relating to factory premises,Part I deals with GMP relating to factory premises,
& Part II deals with plant & equipment for& Part II deals with plant & equipment for
manufacture of drugs.manufacture of drugs.
FACTORY PREMISESFACTORY PREMISES
GENERAl REQUIREMENTS :GENERAl REQUIREMENTS :
Location of factory & its surroundings shouldLocation of factory & its surroundings should
ensure freedom from contamination due to sewage,ensure freedom from contamination due to sewage,
drain & obnoxious odours or fumes, or largedrain & obnoxious odours or fumes, or large
quantity of soot, dust or smoke.quantity of soot, dust or smoke.
Factory building should be so constructed as toFactory building should be so constructed as to
ensure production of drugs under hygienicensure production of drugs under hygienic
conditions.conditions. 44
5. Operations like manufacturing, processing,Operations like manufacturing, processing,
packaging, labelling & testing should be carriedpackaging, labelling & testing should be carried
out in such a way that mix up & crossout in such a way that mix up & cross
contamination are avoided.contamination are avoided.
Premises should be so constructed & maintained asPremises should be so constructed & maintained as
to prevent entry of insects & rodents.to prevent entry of insects & rodents.
Interior surface should be smooth & free fromInterior surface should be smooth & free from
cracks & permit easy cleaning & disinfection.cracks & permit easy cleaning & disinfection.
Adequate lighting, ventilation & humidity must beAdequate lighting, ventilation & humidity must be
maintained.maintained.
Drainage system should be underground.Drainage system should be underground.
Sanitary fitting & electrical fixtures inSanitary fitting & electrical fixtures in
manufacturing area should be concealed.manufacturing area should be concealed. 55
6. Water used in manufacture should be pure & ofWater used in manufacture should be pure & of
a drinkable quality, free from pathogenic micro-a drinkable quality, free from pathogenic micro-
organisms.organisms.
Waste water should be treated before disposal toWaste water should be treated before disposal to
render it harmless.render it harmless.
STERIlE PRODUCTS :STERIlE PRODUCTS :
For manufacture of sterile drugs separate enclosedFor manufacture of sterile drugs separate enclosed
areas provided with air locks, dust free, ventilatedareas provided with air locks, dust free, ventilated
with air supply through HEPA filters, arewith air supply through HEPA filters, are
recommended.recommended.
During manufacturing operation routine microbialDuring manufacturing operation routine microbial
counts of area is necessary.counts of area is necessary. 66
7. Access to manufacturing areas should be restrictedAccess to manufacturing areas should be restricted
to authorized personnel.to authorized personnel.
Design of area must preclude possibility of mix upDesign of area must preclude possibility of mix up
between sterile & non-sterile.between sterile & non-sterile.
WORKING SPACE :WORKING SPACE :
Adequate working space & adequate room forAdequate working space & adequate room for
orderly placement of equipment & materialsorderly placement of equipment & materials
should be provided to eliminate any risk of mixshould be provided to eliminate any risk of mix
up between different drugs, & crossup between different drugs, & cross
contamination.contamination.
In storage area separate space should be providedIn storage area separate space should be provided
for "under test", "approved" & "rejected" materials.for "under test", "approved" & "rejected" materials.77
12. HEALTH, CLOTHING & SANITATION OFHEALTH, CLOTHING & SANITATION OF
WORKERSWORKERS
All personnel coming in direct contact withAll personnel coming in direct contact with
products including raw materials should be freeproducts including raw materials should be free
from contagious or obnoxious diseases & shouldfrom contagious or obnoxious diseases & should
undergo periodic health check up.undergo periodic health check up.
Just before entry to manufacturing area, changeJust before entry to manufacturing area, change
room with facility for personnel cleanliness shouldroom with facility for personnel cleanliness should
also be provided.also be provided.
MEDICAL SERVICES :MEDICAL SERVICES :
Manufacturer should provideManufacturer should provide
(i)(i) adequate facilities for first aid.adequate facilities for first aid.
(ii) Medical examination of workers at time of(ii) Medical examination of workers at time of
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13. a year.a year.
(iii) Facility for vaccination.(iii) Facility for vaccination.
Services of qualified physician forServices of qualified physician for assesingassesing
health status of personnel involved inhealth status of personnel involved in
manufacturing &manufacturing & qualitquality control of drugs shouldy control of drugs should
also be made available.also be made available.
SANITATION IN MANUFACTURINGSANITATION IN MANUFACTURING
PREMISES :PREMISES :
Manufacturing area should not be utilized for anyManufacturing area should not be utilized for any
other purpose & should be maintained cleanother purpose & should be maintained clean inin anan
orderly manner, free from accumulated waste, dust,orderly manner, free from accumulated waste, dust,
debris etc.debris etc.
Routine sanitation programme should be drawn upRoutine sanitation programme should be drawn up1313
14. EQUIPMENT :EQUIPMENT :
Equipment used for manufacture of drugs shouldEquipment used for manufacture of drugs should
Be constructed, designed, installed & maintained toBe constructed, designed, installed & maintained to
(i) Achieve to operational efficiency to attain(i) Achieve to operational efficiency to attain
desired quality;desired quality;
(ii) Prevent physical,(ii) Prevent physical, chemical & physico-chemicalchemical & physico-chemical
change through surface contact;change through surface contact;
(iii) Prevent contact of any substance required for(iii) Prevent contact of any substance required for
operation of equipments like lubricants etc.;operation of equipments like lubricants etc.;
(iv)(iv) Facilitate thorough cleaning wherever necessary;Facilitate thorough cleaning wherever necessary;
(v) Minimize any contamination of drugs & their(v) Minimize any contamination of drugs & their
containers duringcontainers during manmanufacture.ufacture.
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15. Specific written cleaning instructions for allSpecific written cleaning instructions for all
equipments & utensils should be readily availableequipments & utensils should be readily available
& operators must be familiar with them.& operators must be familiar with them.
Accuracy, precision & performance of allAccuracy, precision & performance of all
equipmentsequipments should be monitored at regularshould be monitored at regular
intervals.intervals.
RAW MATERIALS :RAW MATERIALS :
All raw materials should beAll raw materials should be
(i) Identified & their containers examined for damage(i) Identified & their containers examined for damage
& assigned control number.& assigned control number.
(ii) Stored(ii) Stored atat optimum temperatures & relativeoptimum temperatures & relative
humidity.humidity.
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16. (iii) Conspicuously labelled(iii) Conspicuously labelled indicating name ofindicating name of
materials; control number, name ofmaterials; control number, name of mamanufacturer &nufacturer &
be specifically labelled "under test" or "approved"be specifically labelled "under test" or "approved"
or rejected.or rejected.
(iv) Systematically sampled by QC personnel.(iv) Systematically sampled by QC personnel.
(vi) Tested for compliance with required standards(vi) Tested for compliance with required standards
of quality.of quality.
(vi) Released from quarantine by quality control(vi) Released from quarantine by quality control
personnel through written instructions.personnel through written instructions.
(vii) So organized that stock rotation is on basis of(vii) So organized that stock rotation is on basis of
'first in first out‘'first in first out‘princprinciple in storage areaiple in storage area
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17. (viii) so arranged that all rejected materials are(viii) so arranged that all rejected materials are
Conspicuously identified & are destroyed orConspicuously identified & are destroyed or
returned to suppliers as soon as possible & recordsreturned to suppliers as soon as possible & records
maintained thereof.maintained thereof.
MASTER FORMULA RECORDS :MASTER FORMULA RECORDS :
Licensee should maintain master formula recordsLicensee should maintain master formula records
relating to all manufacturing procedures for eachrelating to all manufacturing procedures for each
product, which should be prepared & endorsed byproduct, which should be prepared & endorsed by
competent technical staff.competent technical staff.
Master formula record shall giveMaster formula record shall give
(i) Patent or proprietary name of product along with(i) Patent or proprietary name of product along with
generic name, strength & dosagegeneric name, strength & dosage form.form.
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18. (ii) Description or identification of final containers,(ii) Description or identification of final containers,
packagingpackaging materials, labels & closures to be used.materials, labels & closures to be used.
(iii) Identity, quantity & quality of each raw(iii) Identity, quantity & quality of each raw
material to be used.material to be used.
(iv) Description of all vessels & equipments & size(iv) Description of all vessels & equipments & size
used in process.used in process.
(v) Manufacturing & control instructions along with(v) Manufacturing & control instructions along with
parameters for critical steps such as mixing,parameters for critical steps such as mixing,
drying, blending, sieving, sterilizing product.drying, blending, sieving, sterilizing product.
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19. (vi) Theoretical yield to be expected from(vi) Theoretical yield to be expected from
formulation at different stages of manufacture &formulation at different stages of manufacture &
permissible yield limits.permissible yield limits.
(vii) Detailed instructions on precautions to be(vii) Detailed instructions on precautions to be
taken in manufacture & storage of drugs & oftaken in manufacture & storage of drugs & of
semi finished products & requirements of inprocesssemi finished products & requirements of inprocess
quality control test & analysis to be carried outquality control test & analysis to be carried out
during each stage of manufacture includingduring each stage of manufacture including
designation of persons or departments responsibledesignation of persons or departments responsible
for execution of such tests & analysisfor execution of such tests & analysis
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20. BATCH MANUFACTURING RECORDS :BATCH MANUFACTURING RECORDS :
Licensee shall maintain batch manufacturingLicensee shall maintain batch manufacturing
record as per Schedule U for each batch of drugrecord as per Schedule U for each batch of drug
produced.produced.
Manufacturing records are required to provide aManufacturing records are required to provide a
complete account of manufacturing history of eachcomplete account of manufacturing history of each
batch of drug showing that it has beenbatch of drug showing that it has been
manufactured, tested & analyzed in accordancemanufactured, tested & analyzed in accordance
with manufacturing procedures & writtenwith manufacturing procedures & written
instructions as per master formula.instructions as per master formula.
MANUFACTURING OPERATIONS &MANUFACTURING OPERATIONS &
CONTROLS :CONTROLS :
All manufacturing operations should be carried outAll manufacturing operations should be carried out2020
21. Critical steps in process relating to selection,Critical steps in process relating to selection,
weighing & measuring of raw materials duringweighing & measuring of raw materials during
various stages should be performed under directvarious stages should be performed under direct
personnel supervision of a competent technical staff.personnel supervision of a competent technical staff.
Even non-sterile products should be free fromEven non-sterile products should be free from
pathogens like Salmonella, E. Colt, etc.pathogens like Salmonella, E. Colt, etc.
All vessels, containers & mechanicalAll vessels, containers & mechanical
manufacturing equipment should be conspicuouslymanufacturing equipment should be conspicuously
labelled with name of product & batch No.labelled with name of product & batch No.
licensee should prevent cross contamination oflicensee should prevent cross contamination of
drugs.drugs. 2121
22. All process controls as required under masterAll process controls as required under master
formula including room temperature, relativeformula including room temperature, relative
humidity, weight variation, disintegration time ,humidity, weight variation, disintegration time ,
mixing time, homogeneity of suspension, volumemixing time, homogeneity of suspension, volume
filled, leakage, clarity shall be checked & recorded.filled, leakage, clarity shall be checked & recorded.
REPROCESSING &RECOVERY:REPROCESSING &RECOVERY:
If a product batch has to be reprocessed,If a product batch has to be reprocessed,
reprocessing procedure should be authorized &reprocessing procedure should be authorized &
recorded.recorded.
Recovery of product residue may be carried out byRecovery of product residue may be carried out by
incorporating in subsequent batches of product, ifincorporating in subsequent batches of product, if
permitted in master formula.permitted in master formula. 2222
23. PRODUCT CONTAINERS & CLOSURES:PRODUCT CONTAINERS & CLOSURES:
All containers & closures should comply withAll containers & closures should comply with
pharmacopoeial requirements.pharmacopoeial requirements.
Suitable specifications, testSuitable specifications, test methods,methods, cleaningcleaning
procedures & sterilization procedures, whenprocedures & sterilization procedures, when
indicated should be used to assure that containers,indicated should be used to assure that containers,
closures & other component parts of drug packagesclosures & other component parts of drug packages
are suitable & they are not reactive, adsorptive orare suitable & they are not reactive, adsorptive or
leach to an extent that significantly affectsleach to an extent that significantly affects qualitqualityy
or purity of drug.or purity of drug.
Wherever bottles are being used, written scheduleWherever bottles are being used, written schedule
of cleaning should be laid down & followed.of cleaning should be laid down & followed. 2323
24. Where bottlesWhere bottles are driedare dried after washing, they shouldafter washing, they should
be rinsed with deionised waterbe rinsed with deionised water or distilledor distilled water.water.
LABELS & OTHER PRINTED MATERIALS :LABELS & OTHER PRINTED MATERIALS :
Printed labels & packaging materials includingPrinted labels & packaging materials including
leaflets should be stored, handled & accounted inleaflets should be stored, handled & accounted in
such a way as to ensure that batch packagingsuch a way as to ensure that batch packaging
materials & leaflets relating tomaterials & leaflets relating to different productsdifferent products
do not become intermixed.do not become intermixed.
Prior to issue, all labels for containers, cartons &Prior to issue, all labels for containers, cartons &
boxes & all circulars, inserts & leaflets shouldboxes & all circulars, inserts & leaflets should bebe
examined & released as satisfactory for use byexamined & released as satisfactory for use by
quality controlquality control personnel.personnel. 2424
25. A known number of labelling & packaging unitsA known number of labelling & packaging units
should beshould be issuedissued against a written signed request.against a written signed request.
Prior to packaging & labelling ofPrior to packaging & labelling of a givena given batch of abatch of a
drug it must be ensured that batch has been dulydrug it must be ensured that batch has been duly
tested, approved & released by QC personnel.tested, approved & released by QC personnel.
UponUpon completion of packaging & labellingcompletion of packaging & labelling
operation, a comparison shouldoperation, a comparison should bebe made betweenmade between
number of labelling & packaging units issued &number of labelling & packaging units issued &
numbernumber ofof labelled & packaged.labelled & packaged.
Unused, coded & spoiled labels &Unused, coded & spoiled labels & packagingpackaging
materials should be destroyed.materials should be destroyed. 2525
26. DISTRIBUTION RECORDS :DISTRIBUTION RECORDS :
Records for distribution of drug should beRecords for distribution of drug should be
Maintained for distribution of finished batch of aMaintained for distribution of finished batch of a
drug in order to facilitate promptdrug in order to facilitate prompt && complete recallcomplete recall
of batch, if necessary.of batch, if necessary.
RECORDS OF COMPLAINTS & ADVERSERECORDS OF COMPLAINTS & ADVERSE
REACTIONS :REACTIONS :
Reports of serious adverseReports of serious adverse reactions resulting fromreactions resulting from
use of drug along with comments shall be informeduse of drug along with comments shall be informed
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28. QUALITY CONTROL SYSTEM :QUALITY CONTROL SYSTEM :
Every manufacturing establishment shallEvery manufacturing establishment shall have QChave QC
department supervised by an approved expert staffdepartment supervised by an approved expert staff
directly responsible to management butdirectly responsible to management but
independent of other department.independent of other department.
QC department shall control all raw materials,QC department shall control all raw materials, or allor all
in process quality checks & control quality &in process quality checks & control quality &
stability of finished products.stability of finished products.
QC department shall have followingQC department shall have following duties:-duties:-
1. To prepare detailed instructions in writing for1. To prepare detailed instructions in writing for
carrying out eachcarrying out each test & analysis.test & analysis.
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29. 2.2. To release or rejectTo release or reject
(i) each batch of raw materials;(i) each batch of raw materials;
( ii)( ii) semi-finished products,semi-finished products,
(iii) packaging & labelling materials & final(iii) packaging & labelling materials & final
containers in which drugs are to be packed;containers in which drugs are to be packed;
(iv) each batch of finished product ready for(iv) each batch of finished product ready for
distribution;distribution;
3. To evaluate adequacy of conditions under which3. To evaluate adequacy of conditions under which
raw materials, semi-finished products & finishedraw materials, semi-finished products & finished
products are stored;products are stored;
4. To evaluate quality & stability of finished4. To evaluate quality & stability of finished
products &products & of raw materials & semi-finishedof raw materials & semi-finished
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30. 5.5. To establish & when necessary revise, controlTo establish & when necessary revise, control
procedures &procedures & specifications.specifications.
6. To examine returned products as to whether such6. To examine returned products as to whether such
products should be released, reprocessed orproducts should be released, reprocessed or
destroyed.destroyed.
In summary, all areas of activities & proceduresIn summary, all areas of activities & procedures
relating to handlingrelating to handling of materials, manufacturing &of materials, manufacturing &
quality control should be well defined, designed,quality control should be well defined, designed,
implemented & documented.implemented & documented.
Emphasis is on GMP which includes good recordEmphasis is on GMP which includes good record
keeping practice or proper documentation.keeping practice or proper documentation.
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31. It is a means by which manufacturer can fulfil hisIt is a means by which manufacturer can fulfil his
commitment of consumer protection by assuringcommitment of consumer protection by assuring
quality of his drug products.quality of his drug products.
PLANT & EQUIPMENTPLANT & EQUIPMENT
Part II of Schedule M recommends requirementsPart II of Schedule M recommends requirements
of plant & equipment for manufacture of drugsof plant & equipment for manufacture of drugs
under following sections :under following sections :
(i) Ointments, emulsions, lotions & suspensions.(i) Ointments, emulsions, lotions & suspensions.
(ii) Syrups, elixirs & solutions.(ii) Syrups, elixirs & solutions.
(iii) Pills, compressed tablets & hypodermic tablets.(iii) Pills, compressed tablets & hypodermic tablets.
(iv) Powders.(iv) Powders. 3131
32. (v) Hard gelatin capsules.(v) Hard gelatin capsules.
(vi) Surgical dressings other than absorbent cotton(vi) Surgical dressings other than absorbent cotton
wool.wool.
(vii) Eye ointments, Eye lotions & other(vii) Eye ointments, Eye lotions & other
preparations for external use (manufactured underpreparations for external use (manufactured under
aseptic conditions).aseptic conditions).
(viii) Pessaries & suppositories.(viii) Pessaries & suppositories.
(ix) Inhalers & vitrallae.(ix) Inhalers & vitrallae.
(x) Repacking of drugs, Pharmaceuticals & chemicals.(x) Repacking of drugs, Pharmaceuticals & chemicals.
(xi) Parenterals preparations.(xi) Parenterals preparations.
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33. For most of sections an area of minimum 30 sqFor most of sections an area of minimum 30 sq
metres (60 sq metres for parenteral section) ismetres (60 sq metres for parenteral section) is
recommended for basic installation.recommended for basic installation.
Recommended requirements do not includeRecommended requirements do not include
requirement of machinery, equipment & premisesrequirement of machinery, equipment & premises
required for preparation of containers & closures forrequired for preparation of containers & closures for
different categories of drugs.different categories of drugs.
Licensing Authority shall have discretion to relaxLicensing Authority shall have discretion to relax
or alter requirements of Schedule in circumstancesor alter requirements of Schedule in circumstances
of a particular case.of a particular case.
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34. In respect of other categories of drugs not includedIn respect of other categories of drugs not included
in Schedule such as basic drugs, pharmaceuticals,in Schedule such as basic drugs, pharmaceuticals,
chemicals & aids, medicinal gases, empty gelatinchemicals & aids, medicinal gases, empty gelatin
capsules, mechanical contraceptives, new dosagecapsules, mechanical contraceptives, new dosage
forms etc..forms etc..
Licensing Authority shall have discretion toLicensing Authority shall have discretion to
examine factory premises, space, plant & machineryexamine factory premises, space, plant & machinery
& direct manufacturer to carry out necessary& direct manufacturer to carry out necessary
modifications.modifications.
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35. According to provisions of Schedule M & U ofAccording to provisions of Schedule M & U of
Rules it is obligatoryRules it is obligatory manufacturers to effectivelymanufacturers to effectively
destroy, in their factory premises,destroy, in their factory premises, rejecterejected rawd raw
materials, defective drugs rejected duringmaterials, defective drugs rejected during
manufacturing & rejected packing material e.g.manufacturing & rejected packing material e.g.
labels, cartons & tolabels, cartons & to maintainmaintain records.records.
This is essential to curb malpractice of recyclingThis is essential to curb malpractice of recycling
such stocks for manufacture of drugs, which issuch stocks for manufacture of drugs, which is
harmful to public health.harmful to public health.
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