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ICH Q7 FDA原料药GMP指南-2016版发布 FDA近期发布了Q7原料药GMP指南，上一版Q7指南发布于2000年。这份指南的章节结构如下，用户可以点击本文下方“阅读原文”下载全文。 1.2 Regulatory Applicability 2.2 Responsibilities of the Quality Unit(s) 2.3 Responsibility for Production Activities 2.4 Internal Audits (Self Inspection) 2.5 Product Quality Review 3.1 Personnel Qualifications 4. BUILDINGS AND FACILITIES 4.4.1 Design and Construction 4.7 Sanitation and Maintenance 5.1 Design and Construction 5.2 Equipment Maintenance and Cleaning 6. DOCUMENTATION AND RECORDS 6.1 Documentation System and Specifications 6.2 Equipment cleaning and Use Record 6.3 Records of Raw Materials, Intermediates, API Labeling and Packaging Materials6.3 原料、中间体、原料药的标签和包装材料的记录6.4 Master Production Instructions (Master Production and Control Records) 6.5 Batch Production Records (Batch Production and Control Records) 6.6 Laboratory Control Records 6.7 Batch Production Record Review 7.2 Receipt and Quarantine 7.3 Sampling and Testing of Incoming Production Materials 8. PRODUCTION AND IN-PROCESS CONTROLS 8.1 Production Operations 8.3 In-process Sampling and Controls 8.4 Blending Batches of Intermediates or APIs 8.5 Contamination Control 9. PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES 9.3 Label Issuance and Control 9.4 Packaging and Labeling Operations 10. STORAGE AND DISTRIBUTION 10.1 Warehousing Procedures 10.2 Distribution Procedures 11.2 Testing of Intermediates and APIs 11.3 Validation of Analytical Procedures 11.4 Certificates of Analysis 11.5 Stability Monitoring of APIs 11.6 Expiry and Retest Dating11.7 Reserve/Retention Samples 12.2 Validation Documentation 12.4 Approaches to Process Validation 12.5 Process Validation Program 12.6 Periodic Review of Validated Systems 12.8 Validation of Analytical Methods 14. REJECTION AND RE-USE OF MATERIALS 14.4 Recovery of Materials and Solvents 15. COMPLAINTS AND RECALLS 16. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES)17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS 17.代理商、经纪人、贸易商、经销商、重新包装者和重新贴签者17.2 Traceability of Distributed APIs and Intermediates 17.4 Repackaging, Relabeling, and Holding of APIs and Intermediates17.6 Transfer of Information 17.7 Handling of Complaints and Recalls 18. Specific Guidance for APIs Manufactured by Cell Culture/Fermentation18.2 Cell Bank Maintenance and Record Keeping 18.3 Cell Culture/Fermentation 18.4 Harvesting, Isolation and Purification 18.5 Viral Removal/Inactivation steps 19. APIs for Use in Clinical Trials 19.3 Equipment and Facilities19.4 Control of Raw Materials
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