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

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 AGeneral Provisions
§ 211.1Scope.
§ 211.3Definitions.
Subpart BOrganization and Personnel
§ 211.22Responsibilities of quality control unit.
§ 211.25Personnel qualifications.
§ 211.28Personnel responsibilities.
§ 211.34Consultants.
Subpart CBuildings and Facilities
§ 211.42Design and construction features.
§ 211.44Lighting.
§ 211.46Ventilation, air filtration, air heating and cooling.
§ 211.48Plumbing.
§ 211.50Sewage and refuse.
§ 211.52Washing and toilet facilities.
§ 211.56Sanitation.
§ 211.58Maintenance.
Subpart DEquipment
§ 211.63Equipment design, size, and location.
§ 211.65Equipment construction.
§ 211.67Equipment cleaning and maintenance.
§ 211.68Automatic, mechanical, and electronic equipment.
§ 211.72Filters.
Subpart EControl of Components and Drug Product Containers and Closures
§ 211.80General requirements.
§ 211.82Receipt and storage of untested components, drug product containers, and closures.
§ 211.84Testing and approval or rejection of components, drug product containers, and closures.
§ 211.86Use of approved components, drug product containers, and closures.
§ 211.87Retesting of approved components, drug product containers, and closures.
§ 211.89Rejected components, drug product containers, and closures.
§ 211.94Drug product containers and closures.
Subpart FProduction and Process Controls
§ 211.100Written procedures; deviations.
§ 211.101Charge-in of components.
§ 211.103Calculation of yield.
§ 211.105Equipment identification.
§ 211.110Sampling and testing of in-process materials and drug products.
§ 211.111Time limitations on production.
§ 211.113Control of microbiological contamination.
§ 211.115Reprocessing.
Subpart GPackaging and Labeling Control
§ 211.122Materials examination and usage criteria.
§ 211.125Labeling issuance.
§ 211.130Packaging and labeling operations.
§ 211.132Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.
§ 211.134Drug product inspection.
§ 211.137Expiration dating.
Subpart HHolding and Distribution
§ 211.142Warehousing procedures.
§ 211.150Distribution procedures.
Subpart ILaboratory Controls
§ 211.160General requirements.
§ 211.165Testing and release for distribution.
§ 211.166Stability testing.
§ 211.167Special testing requirements.
§ 211.170Reserve samples.
§ 211.173Laboratory animals.
§ 211.176Penicillin contamination.
Subpart JRecords and Reports
§ 211.180General requirements.
§ 211.182Equipment cleaning and use log.
§ 211.184Component, drug product container, closure, and labeling records.
§ 211.186Master production and control records.
§ 211.188Batch production and control records.
§ 211.192Production record review.
§ 211.194Laboratory records.
§ 211.196Distribution records.
§ 211.198Complaint files.
Subpart KReturned and Salvaged Drug Products
§ 211.204Returned drug products.
§ 211.208Drug product salvaging.
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FDAの便利なデータベースへのリンク一覧
2023年12月17日
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PIC/sのGMP要求事項のリンク集
2023年12月19日