Pharmaceutical manufacturing has become a significant industry in India. It has been estimated that has the third largest pharmaceutical industry by volume We will examine how well they comply with Good Manufacturing Practices (GMP).
This document discusses the batch manufacturing record (BMR) process for pharmaceutical companies. It provides details on:
- The responsibilities of quality assurance, production, and quality control in preparing, processing, reviewing, and approving BMRs.
- The documentation required in a BMR including equipment used, process parameters, batch details, packaging information, and analytical testing results.
- The standard operating procedures for issuing a BMR, documenting the batch production process, reviewing the completed BMR, and retaining records.
The document provides an overview of current good manufacturing practices (cGMP) as defined by the World Health Organization (WHO). It discusses key aspects of cGMP including personnel, facilities, equipment, material management, quality management, manufacturing operations, validation, sterile products, security, documentation, and records. The goal of cGMP is to consistently produce pharmaceutical products that meet quality standards for their intended use and legal requirements.
This document provides an introduction to Good Laboratory Practices (GLP). It defines GLP as a quality system for non-clinical health and environmental safety studies. The document outlines the history of GLP, elements of GLP including standard operating procedures and quality assurance units, objectives of GLP, scope of GLP application, and principles of GLP. It describes GLP as having four pillars: management, quality assurance, study director, and national compliance monitoring authorities. The goal of GLP is to ensure quality and integrity in laboratory studies submitted to regulatory authorities.
The document provides information about the US Food and Drug Administration (FDA):
- The FDA is a regulatory agency within the US Department of Health that is responsible for protecting public health by ensuring the safety of foods, drugs, medical devices, and other products.
- The FDA regulates a wide range of products including biologics, cosmetics, drugs, foods, medical devices, radiation-emitting electronics, veterinary products and tobacco.
- The agency is organized into centers that focus on specific regulatory areas like drugs, biologics, foods and medical devices. Major regulations are codified in the Code of Federal Regulations Title 21.
Indian GMP Certification & WHO GMP CertificationVishal Shelke
Indian GMP Certification & WHO GMP Certification by Mr. Vishal Shelke
https://youtube.com/vishalshelke99
https://instagram.com/vishal_stagram
Sub :- Drug Regulatory Affairs
M.Pharm Sem II
Savitribai Phule Pune University
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 personnel training and responsibilities in the pharmaceutical industry. It outlines that manufacturers must have qualified personnel to carry out tasks and ensure quality assurance. Key personnel such as production heads and quality heads must be independent and possess scientific education and experience. Their responsibilities include authorizing documents, monitoring manufacturing environment, training staff, and approving materials. The authorized person is responsible for approving finished product batches and ensuring compliance with regulations before release. Training programs should be provided for all staff.
This document outlines personnel requirements according to Good Manufacturing Practices (GMP). It states that there must be enough qualified staff to carry out all manufacturing responsibilities. Key points include that each employee must have suitable education, training, and experience for their roles. Manufacturers must have an organization chart and clearly defined duties for positions like production head, quality assurance head, and quality control head. Training is also required for relevant staff. Personal hygiene programs tailored to different facility needs must be established and strictly followed.
This document discusses the batch manufacturing record (BMR) process for pharmaceutical companies. It provides details on:
- The responsibilities of quality assurance, production, and quality control in preparing, processing, reviewing, and approving BMRs.
- The documentation required in a BMR including equipment used, process parameters, batch details, packaging information, and analytical testing results.
- The standard operating procedures for issuing a BMR, documenting the batch production process, reviewing the completed BMR, and retaining records.
The document provides an overview of current good manufacturing practices (cGMP) as defined by the World Health Organization (WHO). It discusses key aspects of cGMP including personnel, facilities, equipment, material management, quality management, manufacturing operations, validation, sterile products, security, documentation, and records. The goal of cGMP is to consistently produce pharmaceutical products that meet quality standards for their intended use and legal requirements.
This document provides an introduction to Good Laboratory Practices (GLP). It defines GLP as a quality system for non-clinical health and environmental safety studies. The document outlines the history of GLP, elements of GLP including standard operating procedures and quality assurance units, objectives of GLP, scope of GLP application, and principles of GLP. It describes GLP as having four pillars: management, quality assurance, study director, and national compliance monitoring authorities. The goal of GLP is to ensure quality and integrity in laboratory studies submitted to regulatory authorities.
The document provides information about the US Food and Drug Administration (FDA):
- The FDA is a regulatory agency within the US Department of Health that is responsible for protecting public health by ensuring the safety of foods, drugs, medical devices, and other products.
- The FDA regulates a wide range of products including biologics, cosmetics, drugs, foods, medical devices, radiation-emitting electronics, veterinary products and tobacco.
- The agency is organized into centers that focus on specific regulatory areas like drugs, biologics, foods and medical devices. Major regulations are codified in the Code of Federal Regulations Title 21.
Indian GMP Certification & WHO GMP CertificationVishal Shelke
Indian GMP Certification & WHO GMP Certification by Mr. Vishal Shelke
https://youtube.com/vishalshelke99
https://instagram.com/vishal_stagram
Sub :- Drug Regulatory Affairs
M.Pharm Sem II
Savitribai Phule Pune University
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 personnel training and responsibilities in the pharmaceutical industry. It outlines that manufacturers must have qualified personnel to carry out tasks and ensure quality assurance. Key personnel such as production heads and quality heads must be independent and possess scientific education and experience. Their responsibilities include authorizing documents, monitoring manufacturing environment, training staff, and approving materials. The authorized person is responsible for approving finished product batches and ensuring compliance with regulations before release. Training programs should be provided for all staff.
This document outlines personnel requirements according to Good Manufacturing Practices (GMP). It states that there must be enough qualified staff to carry out all manufacturing responsibilities. Key points include that each employee must have suitable education, training, and experience for their roles. Manufacturers must have an organization chart and clearly defined duties for positions like production head, quality assurance head, and quality control head. Training is also required for relevant staff. Personal hygiene programs tailored to different facility needs must be established and strictly followed.
This document provides an overview of Good Laboratory Practices (GLP). It discusses that GLP aims to assure regulatory authorities that safety study data submitted to them are reliable and accurate. The document traces the history and development of GLP from cases of poor laboratory practices in the 1970s. It describes the key principles of GLP including requirements for facilities, equipment, test systems, personnel responsibilities, standard operating procedures, and reporting of study results. Adherence to GLP aims to produce high quality and integrity of nonclinical safety data.
GLP principles were created by the USFDA and OECD to establish standardized practices in non-clinical laboratory studies due to past malpractices. GLP aims to ensure study data accurately reflects results and is traceable by regulating an organization's quality system, facilities, equipment, test systems, operating procedures, personnel qualifications, protocols, records, reports and archiving. Key aspects of GLP include establishing responsibilities for management, study directors and quality assurance units and having standard operating procedures for conducting studies, testing facilities, equipment, reagents and animal care in accordance with approved protocols.
Quality control measures in pharmaceutical industryChemOnTheGo
QUALITY CONTROL
ROLE OF QUALITY CONTROL IN PHARMACEUTICAL INDUSTRY
OBJECTIVES OF QUALITY CONTROL
STEPS IN QUALITY CONTROL
COST OF QUALITY CONTROL
TOTAL QUALITY MANAGEMENT
QUALITY CIRCLE
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 provides an introduction to Good Laboratory Practices (GLP). It defines GLP as a system of management controls for non-clinical safety studies to ensure quality and reliability of test data. The document outlines the history, elements, objectives, scope and principles of GLP. It discusses key aspects like standard operating procedures, quality assurance units, the roles of management, study directors and compliance monitoring authorities. Overall, the document serves as a comprehensive overview of GLP for conducting quality non-clinical safety studies.
Regulatory affairs in Pharmaceutical IndustryRama Shukla
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
The FDA is the government agency responsible for regulating food, drugs, medical devices, and other products in the United States. It has headquarters in Maryland and over 200 field offices across the country. The FDA regulates items like foods, drugs, medical devices, vaccines, and more to ensure they are safe and properly labeled. It is made up of centers that focus on specific product areas like drugs, devices, food, tobacco, and more. The document provides details on the FDA's structure, responsibilities, processes, and international collaboration efforts.
The document summarizes the WHO Prequalification Programme, which aims to ensure that medicines and health products meet global standards of quality, safety and efficacy. The key points are:
1. The programme comprehensively evaluates products based on manufacturer submissions and site inspections to verify compliance with WHO standards. Products that meet standards are added to the WHO prequalified lists.
2. The programme was launched in 2001 to address quality issues with medicines for HIV/AIDS, malaria, and tuberculosis in developing countries. It has since expanded to other health products and diseases.
3. The prequalification process involves an expression of interest, dossier submission and evaluation, site inspections, listing of prequalified products, ongoing monitoring, and de
The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments.
The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.
The FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs.
These include sanitation requirements on interstate travel and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction.
The document discusses Good Laboratory Practices (GLP). It provides definitions and history of GLP. GLP refers to a quality management system for laboratories conducting non-clinical safety studies. It aims to ensure reliability and integrity of test data. Key aspects of GLP include organization, SOPs, facilities, equipment, test systems, study planning and reporting, archiving. Non-compliance can result in disqualification and rejection of study data by regulatory agencies.
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
GLP provides a quality system for non-clinical laboratory studies to ensure reliability of results. It aims to develop quality test data and avoid duplication through adherence to standards for organization, personnel, facilities, equipment, operation of studies and reporting. GLP was created by the FDA in 1978 and adopted internationally by organizations like OECD to facilitate acceptance of study data across regions.
The document summarizes the drug regulatory system in India. The key points are:
- The Central Drugs Standard Control Organization (CDSCO) regulates pharmaceuticals and medical devices under the Ministry of Health and Family Welfare.
- CDSCO's functions include ensuring drug safety, efficacy and quality; approving new drugs and clinical trials.
- The Drugs Controller General of India heads CDSCO and is advised by the Drug Technical Advisory Board and Drugs Consultative Committee.
- State drug control administrations enforce drug regulation at the state level under the central Drugs and Cosmetics Act.
The document defines Good Laboratory Practice (GLP) and describes its key principles and objectives. GLP provides a framework for conducting non-clinical health and environmental safety studies to ensure reliability and reproducibility. The main elements of GLP include qualified personnel, adequate facilities and equipment, standard operating procedures, test and control article handling, and documentation and record keeping. GLP aims to assure accurate study results and promote international acceptance of safety tests.
This document provides an overview of the key departments and functions within the pharmaceutical industry. It describes the roles of production, quality control, quality assurance, engineering, regulatory affairs, and clinical research organizations. It also outlines the responsibilities of key personnel like heads of production and quality control, as well as the qualified person. The document emphasizes that effective quality management systems are important for product realization, process control, and continual improvement.
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.
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.
This document provides an overview of Good Laboratory Practices (GLP). It discusses that GLP aims to assure regulatory authorities that safety study data submitted to them are reliable and accurate. The document traces the history and development of GLP from cases of poor laboratory practices in the 1970s. It describes the key principles of GLP including requirements for facilities, equipment, test systems, personnel responsibilities, standard operating procedures, and reporting of study results. Adherence to GLP aims to produce high quality and integrity of nonclinical safety data.
GLP principles were created by the USFDA and OECD to establish standardized practices in non-clinical laboratory studies due to past malpractices. GLP aims to ensure study data accurately reflects results and is traceable by regulating an organization's quality system, facilities, equipment, test systems, operating procedures, personnel qualifications, protocols, records, reports and archiving. Key aspects of GLP include establishing responsibilities for management, study directors and quality assurance units and having standard operating procedures for conducting studies, testing facilities, equipment, reagents and animal care in accordance with approved protocols.
Quality control measures in pharmaceutical industryChemOnTheGo
QUALITY CONTROL
ROLE OF QUALITY CONTROL IN PHARMACEUTICAL INDUSTRY
OBJECTIVES OF QUALITY CONTROL
STEPS IN QUALITY CONTROL
COST OF QUALITY CONTROL
TOTAL QUALITY MANAGEMENT
QUALITY CIRCLE
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 provides an introduction to Good Laboratory Practices (GLP). It defines GLP as a system of management controls for non-clinical safety studies to ensure quality and reliability of test data. The document outlines the history, elements, objectives, scope and principles of GLP. It discusses key aspects like standard operating procedures, quality assurance units, the roles of management, study directors and compliance monitoring authorities. Overall, the document serves as a comprehensive overview of GLP for conducting quality non-clinical safety studies.
Regulatory affairs in Pharmaceutical IndustryRama Shukla
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
The FDA is the government agency responsible for regulating food, drugs, medical devices, and other products in the United States. It has headquarters in Maryland and over 200 field offices across the country. The FDA regulates items like foods, drugs, medical devices, vaccines, and more to ensure they are safe and properly labeled. It is made up of centers that focus on specific product areas like drugs, devices, food, tobacco, and more. The document provides details on the FDA's structure, responsibilities, processes, and international collaboration efforts.
The document summarizes the WHO Prequalification Programme, which aims to ensure that medicines and health products meet global standards of quality, safety and efficacy. The key points are:
1. The programme comprehensively evaluates products based on manufacturer submissions and site inspections to verify compliance with WHO standards. Products that meet standards are added to the WHO prequalified lists.
2. The programme was launched in 2001 to address quality issues with medicines for HIV/AIDS, malaria, and tuberculosis in developing countries. It has since expanded to other health products and diseases.
3. The prequalification process involves an expression of interest, dossier submission and evaluation, site inspections, listing of prequalified products, ongoing monitoring, and de
The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments.
The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.
The FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs.
These include sanitation requirements on interstate travel and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction.
The document discusses Good Laboratory Practices (GLP). It provides definitions and history of GLP. GLP refers to a quality management system for laboratories conducting non-clinical safety studies. It aims to ensure reliability and integrity of test data. Key aspects of GLP include organization, SOPs, facilities, equipment, test systems, study planning and reporting, archiving. Non-compliance can result in disqualification and rejection of study data by regulatory agencies.
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
GLP provides a quality system for non-clinical laboratory studies to ensure reliability of results. It aims to develop quality test data and avoid duplication through adherence to standards for organization, personnel, facilities, equipment, operation of studies and reporting. GLP was created by the FDA in 1978 and adopted internationally by organizations like OECD to facilitate acceptance of study data across regions.
The document summarizes the drug regulatory system in India. The key points are:
- The Central Drugs Standard Control Organization (CDSCO) regulates pharmaceuticals and medical devices under the Ministry of Health and Family Welfare.
- CDSCO's functions include ensuring drug safety, efficacy and quality; approving new drugs and clinical trials.
- The Drugs Controller General of India heads CDSCO and is advised by the Drug Technical Advisory Board and Drugs Consultative Committee.
- State drug control administrations enforce drug regulation at the state level under the central Drugs and Cosmetics Act.
The document defines Good Laboratory Practice (GLP) and describes its key principles and objectives. GLP provides a framework for conducting non-clinical health and environmental safety studies to ensure reliability and reproducibility. The main elements of GLP include qualified personnel, adequate facilities and equipment, standard operating procedures, test and control article handling, and documentation and record keeping. GLP aims to assure accurate study results and promote international acceptance of safety tests.
This document provides an overview of the key departments and functions within the pharmaceutical industry. It describes the roles of production, quality control, quality assurance, engineering, regulatory affairs, and clinical research organizations. It also outlines the responsibilities of key personnel like heads of production and quality control, as well as the qualified person. The document emphasizes that effective quality management systems are important for product realization, process control, and continual improvement.
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.
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.
This presentation provides an overview of the history of drug regulations and Good Manufacturing Practices (GMPs) in the United States. It describes how regulations have evolved over time in response to safety issues and tragedies, from the early 1900s to present day, with the goal of ensuring drug products are safe and effective. Key events and acts that shaped regulations are highlighted, including the Federal Food, Drug, and Cosmetic Act of 1938 and amendments requiring proof of efficacy and safety testing.
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.
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.
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 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.
Copp - CERTIFICATE OF PHARMACEUTICAL PRODUCTSuraj Pamadi
The document discusses the Certificate of Pharmaceutical Product (CoPP), which is issued by regulatory authorities to help importing countries assess the quality of pharmaceutical products. It outlines the importance of the CoPP for product registration in other countries. The summary also describes the application process for obtaining a CoPP in India, including requirements for documentation, inspections, and the format of the certificate.
The document discusses the WHO certification scheme for pharmaceutical products. It provides details on the history and revisions of the WHO certification scheme. It describes the types of certificates that can be issued under the scheme including certificates of pharmaceutical products, statements of licensing status, and batch certificates. It outlines the guidelines for participation in the scheme, requesting and issuing certificates, and procedures for investigating quality defects. The aim of the scheme is to help assure good manufacturing practices and quality of pharmaceutical products being exported between member states.
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 document contains details about a student named Srikanth Bandi enrolled in the Pharmaceutics department. It discusses accelerated stability testing, which involves exposing pharmaceutical products to elevated temperatures to simulate long-term shelf conditions over a shorter time period. The objectives and guidelines from the ICH are outlined, including storage conditions, sampling times, and test parameters. The document also describes the equipment used and process for conducting accelerated stability studies.
The International Council for Harmonisation (ICH) is a joint regulatory-industry initiative to harmonize technical requirements for pharmaceutical product registration. It aims to reduce duplication of testing by achieving greater harmonization in guidelines' interpretation between Europe, Japan, and the United States. ICH addresses safety, quality, efficacy, and other topics through guidelines developed by expert working groups representing regulators and industry. Over two decades, ICH has successfully harmonized guidelines through scientific consensus.
The International Conference on Harmonisation (ICH) was created in 1990 as a unique effort between regulators and industry from the EU, Japan, and US to harmonize technical requirements for pharmaceutical registration. ICH aims to ensure safety, efficacy, and quality of medicines while preventing duplicative trials and minimizing animal testing. Through guidelines developed via consensus building among members, ICH has harmonized requirements for drug development and approval processes. However, some concerns remain regarding inclusion of non-members in the decision making and implications for developing countries.
GMP & Quality Assurance Training by Fakultas Farmasi Universitas AndalasAtlantic Training, LLC.
GMP and quality assurance systems ensure that products are consistently manufactured and controlled according to quality standards for their intended use. QA encompasses all aspects that influence quality, including GMP and quality control. GMP specifies the production and control procedures that need to be followed. QC, as part of GMP, covers sampling, testing, and release of products to ensure the necessary tests are conducted and products meet specifications before release. Together, QA, GMP and QC work to build quality into every aspect of production from start to finish.
Good Manufacturing Practices Training by International Food Safety ConsultancyAtlantic Training, LLC.
This document outlines Good Manufacturing Practices (GMP) for food safety. It discusses sanitation standard operating procedures, food safety on primary production, facility design and maintenance, control of operations including time/temperature, water quality, pest control, cleaning procedures, labeling, and training. The goal of GMP is to produce safe food through prerequisite programs that provide basic environmental and operating conditions.
Good Manufacturing Practice (“GMP”) Compliance: GMPs EXPLAINED by SIDLEY AUST...Atlantic Training, LLC.
The document outlines Good Manufacturing Practices (GMP) that must be followed in the pharmaceutical industry to ensure safety, identity, strength, quality, and purity of drugs. It discusses GMP requirements for facilities, equipment, production, packaging, labeling, quality control, auditing and more. Failure to comply with GMPs can result in severe consequences for companies such as product seizures, recalls, injunctions and criminal penalties. The document was presented at a pharmaceutical regulatory conference to explain GMP compliance.
(i) Not below the rank of Deputy Drugs Controller
(ii) Qualification as prescribed for licensing authority
Functions:
(i) Grant/renewal/suspension/cancellation of licences
(ii) Inspection of premises
(iii) Collection of samples
(iv) Prosecution of offenders
SJTPC 25
Controlling authority
Qualification:
(i) Graduate in Pharmacy or Pharmaceutical
Chemistry or Medicine with specialization in
clinical pharmacology or microbiology
Functions:
(i) Co-ordination and unification of the activities of all
licensing authorities under it.
(ii) Appellate authority against the orders
The CBSE will declare results for the Secondary School Examination 2011 (Class X) for the Delhi region on May 31, 2011 at 7:00 PM. Students can access results through various online modes, including websites and an IVRS system. Results can also be obtained through SMS by sending the roll number to the listed phone numbers of different operators. The document provides details on accessing results through these various online and SMS-based methods.
GMP Manufacturing for Worldwide Clinical Trials InstantGMP™
The document discusses GMP compliance for clinical trial manufacturing on a global scale. It notes that while ICH guidelines provide standards, approaches to compliance vary significantly between countries depending on factors like a nation's development level. Oversight and enforcement are also inconsistent internationally. For clinical trials, understanding both local regulations and real-world enforcement is important when manufacturing, packaging, or distributing investigational products worldwide.
Any company involved in the dietary supplement business has to establish and to follow GMPs to ensure that packaging and labeling is done as specified in the master manufacturing record and to ensure the quality of the product that reaches the market. The presentation provides an overview of these requirements.
Making GMP Materials in a Non-GMP SpaceInstantGMP™
This document discusses how Phase 1 clinical materials can be produced in non-GMP facilities using InstantGMP, an electronic manufacturing system. It outlines FDA guidance for Phase 1 GMP which defines necessary quality control procedures and documentation. InstantGMP allows non-GMP facilities to meet these requirements by providing a comprehensive electronic batch record system that streamlines production and ensures compliance. It automatically documents the entire process and permits remote access.
Specifications for GMP Dietary SupplementsInstantGMP™
Every manufacturer or distributor of dietary supplements has to be in compliance with Good Manufacturing Practices (GMP) requirements. GMP compliance for dietary supplements requires that products must meet specifications for identity, purity, strength, and composition and limits on contaminants. Also specifications are necessary to prevent adulteration as a result of what the manufacturer may do or fail to do in its manufacturing operation.
Instant GMP Compliance Series for Dietary Supplements – Cost of ComplianceInstantGMP™
InstantGMP is a manufacturing execution system that helps dietary supplement companies comply with cGMP requirements in an easy and cost-effective way. It incorporates all manufacturing processes electronically to provide flexibility, speed, and real-time information access. Using built-in quality procedures and automated compliance checks, it reduces errors, deviations, and the costs of compliance compared to traditional paper-based systems. The web-based application makes all manufacturing data visible at all times to streamline operations and increase quality and productivity for dietary supplement companies.
EBR management in the pharmaceutical industryPritam singh
This document discusses electronic batch record management systems in the pharmaceutical industry. It explains that electronic batch record (EBR) systems allow pharmaceutical companies to digitize their production batch records for increased efficiency compared to traditional paper-based systems. The document outlines the benefits of EBR systems, such as reduced cycle times and improved accuracy, but also notes challenges in selecting and implementing a suitable EBR software solution.
Electronic batch record management in pharmaceutical industryVikrant Kalal
The document discusses electronic batch record (EBR) systems in the pharmaceutical industry. It begins by explaining that pharmaceutical companies have traditionally used paper-based batch records but are now shifting to EBR systems to reduce paperwork. It then covers the benefits of EBR systems, such as improved accuracy, reduced costs and cycle times. The document also outlines four types of EBR systems - paper, document management, data collection and manufacturing execution - and discusses challenges in implementing EBR systems. It concludes that EBR systems can significantly reduce the burden of paperwork in pharmaceutical manufacturing.
Electronic batch record management in pharmaceutical industrysadhish jain
The document discusses electronic batch record (EBR) systems in the pharmaceutical industry. It begins by explaining that pharmaceutical companies have traditionally used paper-based batch records but are now shifting to EBR systems to reduce paperwork. It then covers the benefits of EBR systems, such as improved accuracy, reduced costs and cycle times. The document also outlines four types of EBR systems - paper, document management, data collection and manufacturing execution - and discusses challenges in implementing EBR systems. It concludes that EBR systems can significantly reduce the burden of paperwork in pharmaceutical manufacturing.
Computer system validation review article by-mahesh b wazadeMahesh B. Wazade
Computer system validation (CSV) is the process of documenting that a computer system meets defined system requirements. It ensures computerized systems perform as intended in a consistent manner. CSV is important for regulated industries like pharmaceuticals where computer systems are used for quality control and record-keeping. Regulations like 21 CFR Part 11 require electronic records to be validated. CSV enhances reliability and reduces errors and risks to integrity.
The biopharmaceutical industries has more and more used computers to support and accelrate producing of their
products. Computer systems also are accustomed support routine offer of high quality products to boost production
process performance, scale back production prices, and improve product quality. it's vital that these systems square
measure suitable purpose from a business and restrictive perspective. Regulatory authorities treat a lack of regulatory
computer system compliance as a serious GxP deviation. The objective of regulated computer systems includes systems
used to manage data or support descion making subject to review by regulated authorities whether they are being
submitted because its impact on quality or on business. Investments in computer systems supporting the quality controls
to ensure that the process is followed correctly, reducing human error and the need to conduct manual checks,
Standardization of practices to build consistent ways of working, Speed-up of process cycle times by reducing wait times
and by improved scheduling...etc.Computer systems shouldn't be enforced only for restrictive compliance; operational
advantages must always be exploredas well. “U.S. Code of Federal Regulation 21 CFR Part 600, 606, and 610” and “EU
Directive 2003/94/EEC” are the prominent regulations reqested CSV, while “Volume 4 Good Manufacturing Practice
Medicinal Products for Human and Veterinary Use - Annex 11: Computerised Systems” considered the main guidlines for
CSV in biopharmaceutical industries in European Union. This paper aims to provide simplifed guidance on the basic
requireents for computer system validation (CSV) based on the latest regulatory developments and industry trends. In
conclusion, CSV has the great impact on the processes improvement. Also the critical parameters of computer systems
validation for biopharmaceutical indsutries are highlighted.
#AHMED_HASHAM
https://medwinpublishers.com/OAJPR/computerized-systems-validation-csv-in-biopharmaceutical-industries.pdf
The document discusses Good Automated Manufacturing Practice (GAMP), which are guidelines for manufacturers and users of automated systems in the pharmaceutical industry published by the International Society for Pharmaceutical Engineering (ISPE). GAMP aims to ensure pharmaceutical products have the required quality by establishing principles and procedures for validating automated systems. Key aspects of GAMP covered in the document include focusing on building quality into each stage of manufacturing rather than testing it in, covering all production aspects from raw materials to staff training. The document also summarizes the GAMP5 guidelines released in 2008, which provide a framework for validating computerized systems to ensure they are fit for use and compliant with regulations. GAMP5 emphasizes product and process understanding, a lifecycle approach,
This document covers most of the topics in the CSV like Importance of CVS, Why to perform CSV, Validation Deliverables, Part 11 and Annex 11 Diferences
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INTRODUCTION OF Good Manufacturing Practices(GMP) Certificate, AND IT’S REGIS...Rishabhparihar8
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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.
The document provides an overview of computerized system validation. It defines computerized system validation as the process of testing, validating, and qualifying a regulated computerized system to ensure it operates as designed in a consistent and reproducible manner. The document discusses the difference between computer systems and computerized systems, why validation is needed in the pharmaceutical industry, types of validation, applicable regulatory requirements like 21 CFR Part 11, and the GAMP 5 categories for classifying computerized systems. It provides key points about computerized system validation and the V-model approach for validation stages and deliverables.
Overview on “Computer System Validation” CSVAnil Sharma
HI this is Anil Sharma, Executive Compliance in USV LTD. I want to share my brief knowledge on CSV with you. I hope my presentation will help you to understand basics of CSV.
“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”.
The document discusses several topics related to quality assurance of drugs, including emerging trends, key recommendations, tasks for corporate quality assurance units, communication strategies, validation variations, product integrity, managing suppliers and third parties, hazard analysis and critical control points (HACCP), guidelines for applying HACCP, and good automated manufacturing practices (GAMP). Some of the main points discussed are the changing quality assurance environment and need for continuous improvement, effective communication across the organization, risk-based auditing, ensuring product validation is continuously updated, and employing quality control and validation strategies according to ICH standards.
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InstantGMP MD is the latest version of InstantGMP's good manufacturing practices software. MD brings manufacturers of medical devices into cGMP compliance by coming fully validated and compliant with Part 820.
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InstantGMP Compliance Series - Complaints and RecallsInstantGMP™
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InstantGMP Compliance Series - Facility AreasInstantGMP™
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InstantGMP Compliance Series - Facility DesignInstantGMP™
The design of facilities used in the manufacturing of dietary supplements must meet strict requirements for preventing mix-ups and cross contamination. This presentation describes how this can be done.
InstantGMP Compliance Series - EquipmentInstantGMP™
Equipment used in producing dietary supplements fall under Good Manufacturing Practices. This presentation offers guidance on how to keep equipment in compliance.
InstantGMP Compliance Series - Managing Deviations for Improved ComplianceInstantGMP™
Any time a deviation is made from the process in the batch production record, it has to be recorded, investigated and disposition. This presentation provides details on how this is done.
InstantGMP Compliance Series - Improving Quality through In-Process ControlInstantGMP™
In-Process controls are needed at each step of a manufacturing procedure where the control of a critical process can affect the quality of the final product. This presentation explains how to set and use in-process controls.
InstantGMP Compliance Series - Improving SpecificationsInstantGMP™
The FDA requires specifications for identity, strength, purity and composition for dietary supplement products. This presentation explains how to meet these GMP requirements.
InstantGMP Compliance Series - Improving Batch Production RecordsInstantGMP™
Batch record violations were frequently cited during FDA inspections of dietary supplement manufacturers. This presentation provides some guidance on what is needed for batch records to be in compliance with GMPs.
Instant GMP Compliance Series -Better Compliance through Master Manufacturing...InstantGMP™
FDA inspections are increasing every year and they have published the results on their website. 50% of dietary supplement manufacturers are not in GMP compliance and 1 in 4 dietary supplement companies have received a warning letter which could result in a significant enforcement action such as halting production and distribution. Many of these producers received citation because they were not using Master Manufacturing Records.
Instant GMP Compliance Series - Improving DocumentationInstantGMP™
The FDA enforces the Dietary Supplement Health and Education Act (DSHEA) law by inspecting dietary supplement manufacturers, packagers, labelers and holders for Current Good Manufacturing Practices (cGMPs) compliance. One of the main issues they found was the lack of proper documentation. This presentation provides an overview of the documentation that is needed for cGMP compliance.
Unveiling the Dynamic Personalities, Key Dates, and Horoscope Insights: Gemin...my Pandit
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Digital Marketing with a Focus on Sustainabilitysssourabhsharma
Digital Marketing best practices including influencer marketing, content creators, and omnichannel marketing for Sustainable Brands at the Sustainable Cosmetics Summit 2024 in New York
Navigating the world of forex trading can be challenging, especially for beginners. To help you make an informed decision, we have comprehensively compared the best forex brokers in India for 2024. This article, reviewed by Top Forex Brokers Review, will cover featured award winners, the best forex brokers, featured offers, the best copy trading platforms, the best forex brokers for beginners, the best MetaTrader brokers, and recently updated reviews. We will focus on FP Markets, Black Bull, EightCap, IC Markets, and Octa.
Part 2 Deep Dive: Navigating the 2024 Slowdownjeffkluth1
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The global retail industry has weathered numerous storms, with the financial crisis of 2008 serving as a poignant reminder of the sector's resilience and adaptability. However, as we navigate the complex landscape of 2024, retailers face a unique set of challenges that demand innovative strategies and a fundamental shift in mindset. This white paper contrasts the impact of the 2008 recession on the retail sector with the current headwinds retailers are grappling with, while offering a comprehensive roadmap for success in this new paradigm.
[To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
This presentation is a curated compilation of PowerPoint diagrams and templates designed to illustrate 20 different digital transformation frameworks and models. These frameworks are based on recent industry trends and best practices, ensuring that the content remains relevant and up-to-date.
Key highlights include Microsoft's Digital Transformation Framework, which focuses on driving innovation and efficiency, and McKinsey's Ten Guiding Principles, which provide strategic insights for successful digital transformation. Additionally, Forrester's framework emphasizes enhancing customer experiences and modernizing IT infrastructure, while IDC's MaturityScape helps assess and develop organizational digital maturity. MIT's framework explores cutting-edge strategies for achieving digital success.
These materials are perfect for enhancing your business or classroom presentations, offering visual aids to supplement your insights. Please note that while comprehensive, these slides are intended as supplementary resources and may not be complete for standalone instructional purposes.
Frameworks/Models included:
Microsoft’s Digital Transformation Framework
McKinsey’s Ten Guiding Principles of Digital Transformation
Forrester’s Digital Transformation Framework
IDC’s Digital Transformation MaturityScape
MIT’s Digital Transformation Framework
Gartner’s Digital Transformation Framework
Accenture’s Digital Strategy & Enterprise Frameworks
Deloitte’s Digital Industrial Transformation Framework
Capgemini’s Digital Transformation Framework
PwC’s Digital Transformation Framework
Cisco’s Digital Transformation Framework
Cognizant’s Digital Transformation Framework
DXC Technology’s Digital Transformation Framework
The BCG Strategy Palette
McKinsey’s Digital Transformation Framework
Digital Transformation Compass
Four Levels of Digital Maturity
Design Thinking Framework
Business Model Canvas
Customer Journey Map
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Understanding User Needs and Satisfying ThemAggregage
https://www.productmanagementtoday.com/frs/26903918/understanding-user-needs-and-satisfying-them
We know we want to create products which our customers find to be valuable. Whether we label it as customer-centric or product-led depends on how long we've been doing product management. There are three challenges we face when doing this. The obvious challenge is figuring out what our users need; the non-obvious challenges are in creating a shared understanding of those needs and in sensing if what we're doing is meeting those needs.
In this webinar, we won't focus on the research methods for discovering user-needs. We will focus on synthesis of the needs we discover, communication and alignment tools, and how we operationalize addressing those needs.
Industry expert Scott Sehlhorst will:
• Introduce a taxonomy for user goals with real world examples
• Present the Onion Diagram, a tool for contextualizing task-level goals
• Illustrate how customer journey maps capture activity-level and task-level goals
• Demonstrate the best approach to selection and prioritization of user-goals to address
• Highlight the crucial benchmarks, observable changes, in ensuring fulfillment of customer needs
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Introduction
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What is GMP in India?
1. What is GMP in India?
Richard Soltero, Ph.D.
President
InstantGMP
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations
2. International Conference On
Harmonization
ICH Q7A Good Manufacturing Practice Guide
ICH Member Countries –
European Union (EU) - 27 countries
Japan
United States
Australia
Canada
Norway
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations
2
3. Basic of GMPs according to ICH
Instructions and procedures are clear and
unambiguous (in SOPs)
Manufacturing processes are clearly
defined and controlled Records
demonstrate that all required steps were
taken
Facilities designed to minimize cross-
contamination and mix-ups
Operators are trained
Distribution minimizes any risk
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations
3
4. Different approaches to GMPs
compliance depending on country
There is a global disequilibrium – quality
and compliance are different
A nation’s relative development dictates
the level of compliance they can afford
ICH signatories have the best quality
BRIC nations generally are struggling with
the cost of compliance, even while they
recognize the value for international
commerce
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations
4
5. GMP Inspections World Wide
PIC/S (Pharmaceutical Inspection
Cooperation Scheme)
PIC/S references “Good Manufacturing
Practice Guide for Active
Pharmaceutical Ingredients” (ICH Q7A)
Participants include Australia, Canada,
Eastern Europe, EU, Malaysia, SA,
Singapore, UK, US, Taiwan
Not participating: Brazil, Russia, India,
China
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations
5
6. GMP Inspections in India
FDA conducts facility inspections
for products to be sold in the US
Doesn’t include CTM facilities
Doesn’t include clinical stage products
About 100 Indian facilities have
been inspected by the FDA
Otherwise India relies on local
inspectors
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations
6
7. GMP in India
Pharma companies in India
don’t pay taxes for their first
ten years
Over 20,000 pharma
companies in India
They don’t go through
complex certification
procedures
FDA only conducts facility
inspections for products to
be sold in the US
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations
7
8. GMP Regulations in India
Up to 1970, Schedule M of India’s Drug &
Cosmetics Act was in place
Advent of GMP requirements covered the gaps
Regulations were harmful to the small players
Consolidation of Schedule M and GMP put on
hold until 2005
Amendment of Schedule M is more lenient
Small and medium size enterprises are still in
the process of adopting GMPs
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations
8
9. GMP Facilities in India
India is considerate of
the plight of the small
enterprises
So the government is
giving them some slack
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations
9
10. InstantGMP™ - Making GMP
Easy to follow
All-encompassing electronic batch record
system that streamlines entire end-to-end
production of GMP materials
CFR 21 Part 11-compliant software using
an Internet-based infrastructure
Data is automatically visible to everyone at
the same time
Maintains quality compliance automatically
Helps any company become GMP
compliant
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations
11. Comprehensive Solution to
GMP Production
Electronic Batch
Record System
Streamlines end-to-
end production
process
Comes with
complete set of
manufacturing
SOPs and Policies
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations
12. Batch Production Record –
Manufacturing Instructions
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations
12
13. Quick Facts
Developed by the manufacturing and
quality experts at PharmaDirections
Integrated application developed using
“Quality by Design” approach.
Manufacturing Standard Operating
Procedures incorporated into application
Ideally suited for making GMP materials in
an international setting
Software has been in use since 2004
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations
14. Take Home Messages
No one GMP compliance system exists even
in countries that are signatories to ICH
India wants to become compliant, but they
have a long way to go
Most GMP facilities in India are struggling to
pay for the cost of compliance
If you need GMP manufacturing in India, you
have to monitor closely to assure they are in
compliance unless the FDA has approved
them for making your product
InstantGMP: Electronic Manufacturing System for Small Pharmaceutical Operations
Pharmaceutical manufacturing has become a significant industry in India. It has been estimated that has the third largest pharmaceutical industry by volume We are going to examine how well they comply with Good Manufacturing Practices (GMP).>>
The International Conference on Harmonization defined >>Good Manufacturing Practices in their Q7A Guide for Active Pharmaceutical Ingredients. >>This guide was adopted by the ICH Member Countries including the European Union, Japan, the United States, Australia, Canada and Norway. India is conspicuous by its absence from the ICH Conference.>>
There guide for GMP compliance is quite large, but the basics can be boiled down to a few key points. >>Instructions and procedures must clear and unambiguous, and most of all written down in standard operating procedures (SOPs). >>Manufacturing processes have to be clearly defined and controlled and records demonstrate that all required steps were taken. >>Facilities have to be designed to minimize cross-contamination and mix-ups. >>Operators have to trained and training documented. >>Finally it has to be shown that distribution of the drugs to the patients minimizes any risks.>>
While the GMP guide is very complete, there are different approaches to GMP compliance depending on each country. >> There are quite large differences in quality and compliance in different countries. >>In general, a nation’s relative state of development dictates the level of compliance they can afford. >>Countries who are ICH signatories have the best quality. >>BRIC nations including India generally are struggling with the cost of compliance, even though they recognize the value of GMP compliance for selling their product internationally.>>
So the question is “what is GMP in India”? There is a world wide standard for GMP inspections. >>It’s called the Pharmaceutical Inspection Cooperation Scheme. >>That scheme references “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients” (ICH Q7A). >>Participants in this cooperation scheme include Australia, Canada, Eastern Europe, EU, Malaysia, SA, Singapore, UK, US and Taiwan. India is not one of the participating countries.>>
There are GMP inspections occurring in India. >> The FDA does conduct facility inspections for products that are going to be sold in the US. >> Their inspections don’t include clinical trial manufacturing or facilities used to make just clinical stage products or products to be sold locally. >>So far, about 100 Indian facilities have been inspected by the FDA. >>For all others, India relies on their own local GMP inspectors. >>
GMP compliance in India is highly influenced by government and business conditions. >> Pharma companies in India don’t pay taxes for their first ten years which is why >> there are over 20,000 pharmaceutical companies there. >>Pharma companies don’t have to go through a complex certification procedure. >>The FDA only conducts facility inspections only for products to be sold in the US, the rest are left to local inspectors.>>
This has resulted in many GMP facilities in India that very far below international standards. >>Up to 1970, Schedule M of India’s Drug & Cosmetics Act covered only the pharmaceutical company’s location, buildings, equipment, safety and sanitation. >>When GMP requirements were introduced worldwide, it covered the gaps in Schedule M. >> The pharmaceutical manufacturers lobbied in India saying the the Schedule M regulations were harmful to the small players in the pharmaceutical industry. >>The amendment of Schedule M of 2005 which is consolidates with international GMP is more lenient compared with what the US and EU require. >>While small and medium size enterprises are still in the process of adopting GMPs, they are asking to make the existing GMPs even more relaxed.>>
The Indian administration has been considerate of the plight of the small and medium size enterprises. >>They know that small pharmaceutical companies might be shutdown in some states if all the requirements of GMP are enforced so the government is cutting them some slack. >>
There is a way to help out small India pharmaceutical companies using software that makes GMP compliance easy. >> For example, InstantGMP is all-encompassing electronic batch record system that streamlines the entire end-to-end production of GMP materials. => It is CFR 21 Part 11-compliant software which means it complies with the FDA requirements for electronic signatures and electronic documentation. >>It uses an internet-based infrastructure so it is a cloud application that can be accessed from anywhere. >>This means users don’t have to install anything on their servers. They just need an internet connection to use it. >>All data is automatically visible to everyone at the same time and can be monitored in real time. >>This software was designed to maintain quality compliance automatically. =>It can help makes any facility GMP compliant for making pharmaceutical materials. >>
InstantGMP offers a comprehensive solution to GMP production. >> In one system, there are modules for project management, specifications, purchasing, inventory control, room and equipment logs and batch records. >>It is a complete electronic batch record system that streamlines the end to end process of production. >>It comes with a complete set of manufacturing SOPs and Policies.>>
The InstantGMP Electronic Batch Record system was designed to assure compliance with GMPs. The batch production record shows the level of detail and compliance that is enforced through out the system. This screen provides a complete set of instructions for each of the steps in the manufacturing process. It also has areas where results and comments can be entered by the operator and signed off by a supervisor. If a deviation occurs, it can be quickly documented and then is available for review by a Quality Manager. >>
>>InstantGMP was developed by the manufacturing and quality experts at PharmaDirections. >>They developed an integrated application using a “Quality by Design” approach that would automate quality and GMP compliance. >>The manufacturing SOP requirements are incorporated into the application. >> It is ideally suited for making GMP materials in an international setting. >> The software is 21 CFR Part 11 Compliant and has been in use since 2004. >>
There are a few key messages to take home from this presentation. >>In general no one GMP compliance system exists even in countries that are signatories to ICH. >>India does wants to become compliant, but they have a long way to go before all of their industry is fully GMP. >>Most GMP facilities in India are struggling to pay for the cost of compliance. >>If you need GMP manufacturing in India, you have to monitor closely to assure they are in compliance unless the FDA or other regulatory agencies has approved them for making your product.>>
If you are interested in learning more about the electronic batch record system, please visit www.InstantGMP.com.