Inspections (GMP, Others) – Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

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Updated on January 10, 2025

Updated on January 10, 2025

USFDA: Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications – Guidance
USFDA: Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities Guidance for Industry (Sep 2023)
USFDA: Conducting Remote Regulatory Assessments – Questions and Answers (January 2024)
USFDA – Inspection Guides
USFDA: Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection (June 2024)
USFDA: Compliance Program (7356.002): Drug Manufacturing Inspections (Chapter 56: Drug Quality Assurance)
USFDA: Compliance Program (7346.832): Preapproval Inspections (Chapter 46—NEW DRUG EVALUATION)
USFDA: Post-Warning Letter Meetings Under GDUFA (Sep 2023)
EMA & EC (Europe): Conduct of Inspections of Pharmaceutical Manufacturers or Importers
EMA: Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA
EMA: Inspections: verifying compliance
EDQM: The Inspection Programme
WHO: Inspection Services – Medicines
WHO: Guideline To The Inspection Of Hormone Product Manufacturing Facilities (Working document QAS/08.256 February 2008 RESTRICTED) & ISPE Comments
PIC/S Inspection Aide Memoire:
- PIC/S Inspection of Active Pharmaceutical Ingredients
- PIC/S Inspection of Health Based Exposure Limit (HBEL) Assessments and use in Quality Risk Management
- PIC/S Inspection of Pharmaceutical Quality Control Laboratories
- PIC/S Inspection of Utilities
- PIC/S Inspection Of Biotechnology Manufactures
- PIC/S:Inspection of Good Distribution Practice (GDP) for Medicinal Products in the Supply Chain
- PIC/S: Remote Assessments
- PIC/S: Remote Assessments-Aide-Memoire

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