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其它指导性文件

发布时间：2024-01-12 11:17:16  作者：admin  阅读量：4


AllReferenceCategorySection
Aide Memoire on the Inspection of Health Based Exposure Limit (HBEL) Assessments and Use in Quality Risk Management PI 052-1Documents for InspectorsGuidance documents
Good Practices for Computerised Systems in Regulated GXP Environments PI 011-3Documents for InspectorsGuidance documents
Guidance on Classification of GMP Deficiencies PI 040-1Documents for InspectorsGuidance documents
Guidance on Parametric Release PI 005-3Documents for InspectorsGuidance documents
Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments PE 010-4Documents for InspectorsGuidance documents
Isolators Used for Aseptic Processing and Sterility Testing PI 014-3Documents for InspectorsGuidance documents
PIC/S Aide Memoire Inspection of GDP for Medicinal Products in the Supply Chain PI 044-1Documents for InspectorsGuidance documents
PIC/S Good Practice Guidelines for Blood Establishments and Hospital Blood Banks PE 005-4Documents for InspectorsGuidance documents
PIC/S Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments PI 041-1Documents for InspectorsGuidance documents
PIC/S Guidance COVID-19 Risk Assessment for Routine On-Site Inspections PI 055-1Documents for InspectorsGuidance documents
PIC/S Guide to Good Distribution Practice (GDP) for Medicinal Products PE 011-1Documents for InspectorsGuidance documents
PIC/S Guideline on Exposure Limits PI 046-1 Documents for InspectorsGuidance documents
PIC/S Guidelines on Excipient GMP Risk Assessment PI 045-1 Documents for InspectorsGuidance documents
PIC/S Guidelines on GDP of Active Substances for Human Use PI 047-1 Documents for InspectorsGuidance documents
PIC/S Recommendation How to Evaluate and Demonstrate the Effectiveness of the Pharmaceutical Quality System with regard to Risk-Based Change Management PI 054-1Documents for InspectorsGuidance documents
PIC/S Recommendation on Risk-Based Inspection Planning PI 037-1Documents for InspectorsGuidance documents
Questions and Answers (Q&A) on the Implementation of Risk-Based Prevention of Cross-Contamination in Production and ‘Guideline on Setting Health-Based Exposure Limits (HBEL) for Use in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities’ PI 053-1Documents for InspectorsGuidance documents
Recommendation on Sterility Testing PI 012-3Documents for InspectorsGuidance documents
Recommendation on the Qualification and Training of Inspectors in the Field of Human Blood Tissues and Cells PI 026-2Documents for InspectorsGuidance documents
Validation Master Plan Installation and Operational Qualification Non-Sterile Process Validation Cleaning Validation PI 006-3Documents for InspectorsGuidance documents
Validation of Aseptic Processes PI 007-6Documents for InspectorsGuidance documents

原文件链接地址： https://picscheme.org/en/publications?tri=all#selSection_Guidance%20documents

  
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