Inspections (GMP, Others)

Qvents compiled list of regulatory guidelines on GMP inspections from different agencies – USFDA, EMA, EDQM, WHO, PIC-S. Quick reference list:

What are different types of Inspections, GMP Inspection Process, Fees, Links to Inspection guides and checklists, Inspection outcomes, Regulatory actions, Consequences of denying, delaying, refusing GMP inspections, Post inspection remediations, Post Warning letter meetings, Useful presentations on GMP Inspections

• 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 (June 2025)
• 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
• EMA: Questions & Answers on the impact of Mutual Recognition Agreement (MRA) between the European Union and the United States as of 1st October 2025
• 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
• Useful Presentations:
  • Overview of Drug Manufacturing Inspections – 483s, Warning Letters, Inspection Classifications, Regulatory Actions, FDA Dashboards (2023 Webinar presentations by Jennifer Maguire, Simone Pitts, Francis Godwin, Darshini Satchi, Rob Bughman –FDA)