European GCP Inspection standards and guidelines

Eudralex Volume 10: Chapter IV - Inspections

Refer to Chapter IV (Inspections) of Eudralex Volume 10, which covers the following areas:

• Guidance for the preparation of GCP inspections (June 2008)
• Recommendation on inspection procedures for the verification of good clinical practice compliance (July 2006)
• Guidance for the conduct of GCP inspections (June 2008)
• Annex I to Guidance for the conduct of GCP inspections – investigator site (June 2008)
• Annex II to Guidance for the conduct of GCP inspection – clinical laboratories (June 2008)
• Annex III to Guidance for the conduct of GCP inspections – computer systems (June 2008)
• Annex IV to Guidance for the conduct of GCP inspections – Sponsor and CRO (June 2008)
• Annex V to Guidance for the conduct of GCP inspections – Phase I Units (November 2008)
• Annex VI to Guidance for the conduct of GCP inspections - Record keeping and archiving of documents (March 2010)
• Annex VII to Guidance for the conduct of GCP inspections – Bioanalytical part, Pharmacokinetic and Statistical Analyses of Bioequivalence Trials (November 2008)
• Guidance for coordination of GCP inspections and co-operation between GCP inspectors, the reference and concerned Member States and CMD(h) , in the context of the evaluation of the GCP compliance of marketing authorization applications for mutual recognition and decentralized procedures (June 2009)
• Guidance for exchange of GCP Inspection Reports according to Article 15(2) of Directive 2001/20/EC (revision 1 – May 2009)
• Guidance for the communication on GCP inspections and findings (June 2008)
• Procedure for standardisation of GCP inspection entries in EudraCT (November 2008)
• Guidance for the preparation of Good Clinical Practice inspection reports (June 2008)
• Recommendations on the qualifications of inspectors verifying compliance in clinical trials with the provisions of Good Clinical Practice (July 2006)

European Medicines Agency (EMA): GCP Inspections

GCP Inspectors Working Group

Inspection Procedures and Guidance for GCP Inspections Conducted in the Context of the Centralised Procedure

GCP Questions and Answers

• Questions and Answers on Investigational Medicinal Products (IMPs) in Bioavailability and Bioequivalence Trials
• Questions and Answers on GCP Matters
• Question and Answers on Records of Study Subject Data Relating to Clinical Trials