FDAのGMP要求事項のリンク集

2023年12月18日 最終更新日時 : 2024年1月29日 GXP station

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QMS項目	FDA
GMP	・Questions and Answers on Current Good Manufacturing Practices for Drugs
変更管理	・Changes to an Approved NDA or ANDA: Guidance for Industry ・Changes to an Approved NDA or ANDA: Questions and Answers: Guidance for Industry ・Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes: Guidance for Industry ・CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports ・CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports ・Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA
当局報告	・Field Alert Report Submission: Questions and Answers Guidance for Industry: Guidance for Industry
バリデーション	・Process Validation: General Principles and Practices
品質システム	・Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations
逸脱・OOS	・Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision: Guidance for Industry
苦情・偽薬対応	・Report a Problem to the FDA ・Counterfeit Medicine
品質リスクマネジメント	・Q9(R1) Quality Risk Management
規格及び試験方法	・Analytical Procedures and Methods Validation for Drugs and Biologics Reviewer Guidance, Validation of Chromatographic Methods ・The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP): Guidance for Industry
不純物管理	・NDAs: Impurities in Drug Substances ・Residual Solvents in Drug Products Marketed in the United States: Guidance for Industry ・Control of Nitrosamine Impurities in Human Drugs: Guidance for Industry Elemental Impurities in Drug Products Guidance for Industry
製造管理	・Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Q&A ・FDA Guide to Inspections:Validation of Cleaning Processes
原料管理	・Regulatory Considerations for Raw Material Qualification
GMP監査	・Drug Manufacturing Inspections
無菌管理	・Pyrogen and Endotoxins Testing: Questions and Answers ・Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice: Guidance for Industry ・Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products: Guidance for Industry
参考品及び保存サンプル	・Retention Samples
CSV	・Part 11, Electronic Records; Electronic Signatures - Scope and Application: Guidance for Industry
Data Integrity	・Data Integrity and Compliance With Drug CGMP: Questions and Answers: Guidance for Industry
貯法・使用期限・安定性試験	・Expiration Dating and Stability Testing for Human Drug Products ・Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron: Guidance for Industry ・Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products: Guidance for Industry
包装	・Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use: Guidance for Industry
品質取決め	・Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry: Guidance for Industry
治験薬GMP	・Current Good Manufacturing Practice for Phase 1 Investigational Drugs: Guidance for Industry
MRA(相互認証）	・Mutual Recognition Agreements (MRA)

参考情報

Title 21  CFR Part 211 -- Current Good Manufacturing Practice

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.
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.
§ 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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