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Current Good Manufacturing Practices (cgmp)

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The document discusses cGMP (current Good Manufacturing Practices) according to the US FDA. It states that cGMP ensures quality is built into the manufacturing process from start to finish in order to minimize risks and protect product quality. It covers all aspects of manufacturing including facilities & equipment, documentation, personnel training, production & process controls, packaging & labeling, laboratory testing, and distribution. The key goal of cGMP is to assure the identity, strength, purity and quality of drugs. Compliance is required by the FDA regulations under 21 CFR Parts 210, 211, 820 etc.

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cGMPs According to US FDA Good Manufacturing Practice (GMP) ensures that quality is built into the organisation and processes involved in manufacture GMP covers all aspects ofmanufactureincluding collection, transportation, processing,storage,quality control and delivery of the finished product. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product Protect the integrity and quality of manufactured product intended for human use. PRINCIPLES OF cGMP: Design and construct the facilities and equipments properly Follow written procedures and Instructions Document work Validate work Monitor facilities and equipment Write step by step operating procedures and work on instructions Design, develop and demonstrate job competence Protect against contamination Control components and product related processes Conduct planned and periodic audits LIST OF IMPORTANT DOCUMENTS IN cGMP: Policies SOP Specifications MFR (MasterFormula Record) Batch Package Records (BMR) Manuals Masterplans/ files Validation protocols Forms and Formats Records cGMPs cover a broad range of methods, practices and principles that are implemented and documented during product development to ensure consistent manufacture of quality products. the cGMP assures the identity, strength, quality, and purity of drug products is built into the design and manufacturing process at every step. GMP is a dynamic concept and practice. Staying current is driven by technology, improved practices and regulatory issues. USFDA REGULATIONS:- 1. The requirements for compliance to cGMP are lain down in the following code of Federal Regulation (21CFR). 2. 21 CFR Part 210 cGMP in manufacturing, processing,packing, or holding of the drugs 3. 21 CFR Part 211 cGMP for finished pharmaceutical. 4. 21 CFR Part 610 Current Good Manufacture of Biological Products 5. 21 CFR Part 820 Current Good Manufacturing Practices for Devices Essential elements of cGMP are:-
1. Good Documentation Practices 2. Training 3. Facilities and Equipment Management 4. Change Control Systems 5. Operations Oversight and Management cGMP covers:- General consideration, Personal, premises, Equipment, Sanitation, sop's Raw material, self inspection & audit, MFR, BMR, warehousing area, labels & otherprinters Material, Qc CGMP for finished pharmaceuticals: part 211 A. Subpart A - General Provision Scope:- The minimum cGMP for preparation of drug products for administration to humans or animals. The requirements in this part shall not be enforced for OTC drug products and all their ingredients are ordinarily marketed and consumed as human foods. Definitions:-The definitions and interpretations contained in section 201 of the act shall be applicable to such terms when used in this part and in Parts 211 B. Subpart B - Organization & Personnel Responsibilities of quality control unit. Personnel Qualifications. Personnel responsibilities. Consultants. C. Subpart C - Building & Facilities Design and construction features. Lighting. Ventilation, air filtration, air heating and cooling. Plumbing. Sewage and refuse. Washing and toilet facilities. Sanitation. Maintenance D. Subpart D Equipment Equipment design,size, and location. Equipment construction. Equipment cleaning and maintenance. Automatic, mechanical, and electronic equipment. Filters. E. Subpart E - Control of Components & Drug Product Containers & Closures General requirements. Receipt and storage of untested components,drug product containers,and closures. Testing and approval or rejection of components,drug product containers,and closures. Use of approved components, drug product containers, and closures. Retesting of approved components,drug product containers and closures. Rejected components,drug product containers,and closures. Drug product containers and closures. F. Subpart F - Production & Process Control
Written procedures; deviations. Charge-in of components. Calculation of yield. Equipment identification. Sampling and testing of in-process materials and drug products. Time limitations on production. Control of microbiological contamination. Reprocessing. G. Subpart G - Packaging & Labeling Control Materials examination and usage criteria. Labeling issuance. Packaging and labeling operations. Tamper-resistant packaging requirements for over-the-counterhuman drug products. Drug product inspection. Expiration dating. H. Subpart H - Handling & Distribution Warehousing procedures. Distribution procedures. I. Subpart I - Laboratory Control General requirements. Testing and release for distribution. Stability testing. Special testing requirements. Reserve samples. Laboratory animals. Penicillin contaminat J. Subpart J - Records & Reports General requirements. Equipment cleaning and use log. Component, drug product container, closure, and labeling records . Masterproduction and control records. Batch production and control records. Production record review. Laboratory records. Distribution records. Complaint files. K. Subpart K - Returned & Salvaged Drugs Returned drug products. Drug product salvaging.

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Current Good Manufacturing Practices (cgmp)

  • 1. cGMPs According to US FDA Good Manufacturing Practice (GMP) ensures that quality is built into the organisation and processes involved in manufacture GMP covers all aspects ofmanufactureincluding collection, transportation, processing,storage,quality control and delivery of the finished product. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product Protect the integrity and quality of manufactured product intended for human use. PRINCIPLES OF cGMP: Design and construct the facilities and equipments properly Follow written procedures and Instructions Document work Validate work Monitor facilities and equipment Write step by step operating procedures and work on instructions Design, develop and demonstrate job competence Protect against contamination Control components and product related processes Conduct planned and periodic audits LIST OF IMPORTANT DOCUMENTS IN cGMP: Policies SOP Specifications MFR (MasterFormula Record) Batch Package Records (BMR) Manuals Masterplans/ files Validation protocols Forms and Formats Records cGMPs cover a broad range of methods, practices and principles that are implemented and documented during product development to ensure consistent manufacture of quality products. the cGMP assures the identity, strength, quality, and purity of drug products is built into the design and manufacturing process at every step. GMP is a dynamic concept and practice. Staying current is driven by technology, improved practices and regulatory issues. USFDA REGULATIONS:- 1. The requirements for compliance to cGMP are lain down in the following code of Federal Regulation (21CFR). 2. 21 CFR Part 210 cGMP in manufacturing, processing,packing, or holding of the drugs 3. 21 CFR Part 211 cGMP for finished pharmaceutical. 4. 21 CFR Part 610 Current Good Manufacture of Biological Products 5. 21 CFR Part 820 Current Good Manufacturing Practices for Devices Essential elements of cGMP are:-
  • 2. 1. Good Documentation Practices 2. Training 3. Facilities and Equipment Management 4. Change Control Systems 5. Operations Oversight and Management cGMP covers:- General consideration, Personal, premises, Equipment, Sanitation, sop's Raw material, self inspection & audit, MFR, BMR, warehousing area, labels & otherprinters Material, Qc CGMP for finished pharmaceuticals: part 211 A. Subpart A - General Provision Scope:- The minimum cGMP for preparation of drug products for administration to humans or animals. The requirements in this part shall not be enforced for OTC drug products and all their ingredients are ordinarily marketed and consumed as human foods. Definitions:-The definitions and interpretations contained in section 201 of the act shall be applicable to such terms when used in this part and in Parts 211 B. Subpart B - Organization & Personnel Responsibilities of quality control unit. Personnel Qualifications. Personnel responsibilities. Consultants. C. Subpart C - Building & Facilities Design and construction features. Lighting. Ventilation, air filtration, air heating and cooling. Plumbing. Sewage and refuse. Washing and toilet facilities. Sanitation. Maintenance D. Subpart D Equipment Equipment design,size, and location. Equipment construction. Equipment cleaning and maintenance. Automatic, mechanical, and electronic equipment. Filters. E. Subpart E - Control of Components & Drug Product Containers & Closures General requirements. Receipt and storage of untested components,drug product containers,and closures. Testing and approval or rejection of components,drug product containers,and closures. Use of approved components, drug product containers, and closures. Retesting of approved components,drug product containers and closures. Rejected components,drug product containers,and closures. Drug product containers and closures. F. Subpart F - Production & Process Control
  • 3. Written procedures; deviations. Charge-in of components. Calculation of yield. Equipment identification. Sampling and testing of in-process materials and drug products. Time limitations on production. Control of microbiological contamination. Reprocessing. G. Subpart G - Packaging & Labeling Control Materials examination and usage criteria. Labeling issuance. Packaging and labeling operations. Tamper-resistant packaging requirements for over-the-counterhuman drug products. Drug product inspection. Expiration dating. H. Subpart H - Handling & Distribution Warehousing procedures. Distribution procedures. I. Subpart I - Laboratory Control General requirements. Testing and release for distribution. Stability testing. Special testing requirements. Reserve samples. Laboratory animals. Penicillin contaminat J. Subpart J - Records & Reports General requirements. Equipment cleaning and use log. Component, drug product container, closure, and labeling records . Masterproduction and control records. Batch production and control records. Production record review. Laboratory records. Distribution records. Complaint files. K. Subpart K - Returned & Salvaged Drugs Returned drug products. Drug product salvaging.