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  • Current Good Manufacturing Practice - Fda CGMP

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    This document outlines the FDA's Current Good Manufacturing Practice (cGMP) regulations. It contains 12 subparts that establish standards for the manufacture, processing, packing, and holding of human food, dietary supplements, pharmaceuticals, medical devices, blood/blood components, and other biological products. The regulations address facilities and equipment, quality control processes, packaging and labeling, distribution, laboratory testing, recordkeeping, and procedures for returned or salvaged products. Adherence to cGMP helps ensure product quality and safety.

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    This document outlines the FDA's Current Good Manufacturing Practice (cGMP) regulations. It contains 12 subparts that establish standards for the manufacture, processing, packing, and holding of human food, dietary supplements, pharmaceuticals, medical devices, blood/blood components, and other biological products. The regulations address facilities and equipment, quality control processes, packaging and labeling, distribution, laboratory testing, recordkeeping, and procedures for returned or salvaged products. Adherence to cGMP helps ensure product quality and safety.

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    47 views3 pages

    Current Good Manufacturing Practice - Fda CGMP

    Uploaded by

    ckbhai
    This document outlines the FDA's Current Good Manufacturing Practice (cGMP) regulations. It contains 12 subparts that establish standards for the manufacture, processing, packing, and holding of human food, dietary supplements, pharmaceuticals, medical devices, blood/blood components, and other biological products. The regulations address facilities and equipment, quality control processes, packaging and labeling, distribution, laboratory testing, recordkeeping, and procedures for returned or salvaged products. Adherence to cGMP helps ensure product quality and safety.

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    of 3

    Current Good Manufacturing Practice - FDA cGMP

    PART 110
    CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR
    HOLDING HUMAN FOOD
    Part 111
    CURRENT GOOD MANUFACTURING PRACTICE FOR DIETARY SUPPLEMENTS
    PART 211
    CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
    PART 210
    CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING,
    PACKING, OR HOLDING OF DRUGS; GENERAL
    PART 820
    QUALITY SYSTEM REGULATION
    Part 225
    CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS
    Part 226
    CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED
    Part 600
    BIOLOGICAL PRODUCTS: GENERAL
    Part 606
    CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD
    COMPONENTS
    Part 610
    GENERAL BIOLOGICAL PRODUCTS STANDARDS




    Subpart A--General Provisions
    211.1 - Scope.
    211.3 - Definitions.
    Subpart B--Organization and Personnel
    211.22 - Responsibilities of quality control unit.
    211.25 - Personnel qualifications.
    211.28 - Personnel responsibilities.
    211.34 - Consultants.
    Subpart C--Buildings and Facilities
    211.42 - Design and construction features.
    211.44 - Lighting.
    211.46 - Ventilation, air filtration, air heating and cooling.
    211.48 - Plumbing.
    211.50 - Sewage and refuse.
    211.52 - Washing and toilet facilities.
    211.56 - Sanitation.
    211.58 - Maintenance.
    Current Good Manufacturing Practice - FDA cGMP
    Subpart D--Equipment
    211.63 - Equipment design, size, and location.
    211.65 - Equipment construction.
    211.67 - Equipment cleaning and maintenance.
    211.68 - Automatic, mechanical, and electronic equipment.
    211.72 - Filters.
    Subpart E--Control of Components and Drug Product Containers and Closures
    211.80 - General requirements.
    211.82 - Receipt and storage of untested components, drug product containers, and closures.
    211.84 - Testing and approval or rejection of components, drug product containers, and closures.
    211.86 - Use of approved components, drug product containers, and closures.
    211.87 - Retesting of approved components, drug product containers, and closures.
    211.89 - Rejected components, drug product containers, and closures.
    211.94 - Drug product containers and closures.
    Subpart F--Production and Process Controls
    211.100 - Written procedures; deviations.
    211.101 - Charge-in of components.
    211.103 - Calculation of yield.
    211.105 - Equipment identification.
    211.110 - Sampling and testing of in-process materials and drug products.
    211.111 - Time limitations on production.
    211.113 - Control of microbiological contamination.
    211.115 - Reprocessing.
    Subpart G--Packaging and Labeling Control
    211.122 - Materials examination and usage criteria.
    211.125 - Labeling issuance.
    211.130 - Packaging and labeling operations.
    211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.
    211.134 - Drug product inspection.
    211.137 - Expiration dating.
    Subpart H--Holding and Distribution
    211.142 - Warehousing procedures.
    211.150 - Distribution procedures.
    Subpart I--Laboratory Controls
    211.160 - General requirements.
    211.165 - Testing and release for distribution.
    211.166 - Stability testing.
    211.167 - Special testing requirements.
    211.170 - Reserve samples.
    211.173 - Laboratory animals.
    211.176 - Penicillin contamination.
    Subpart J--Records and Reports
    211.180 - General requirements.
    211.182 - Equipment cleaning and use log.
    Current Good Manufacturing Practice - FDA cGMP
    211.184 - Component, drug product container, closure, and labeling records.
    211.186 - Master production and control records.
    211.188 - Batch production and control records.
    211.192 - Production record review.
    211.194 - Laboratory records.
    211.196 - Distribution records.
    211.198 - Complaint files.
    Subpart K--Returned and Salvaged Drug Products
    211.204 - Returned drug products.
    211.208 - Drug product salvaging.

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