Updated Good Clinical Practice (GCP) Inspection Procedures

These Annexes cover updates to the following Procedures for Conducting GCP Inspection Requested by the Committee for Medicinal Products for Human Use (CHMP):

• Annex I: Investigator Site
• Annex II: Clinical Laboratories
• Annex IV: Sponsor and Contract Research Organizations (CRO)
• Annex VI: Record Keeping and Archiving of Documents
• Annex VII: Bioanalytical Part, Pharmacokinetic and Statistical Analyses of Bioequivalence Trials