Updated Good Clinical Practice (GCP) Inspection Procedures

On 5 May 2022 the EMA announced the updates of the guidance on 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
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