Bioequivalence and Bioavailability Forum

Dear Johanne,

- for the clinical part of a trial, the Glossary of the ICH GCP guideline defines an audit certificate as A declaration of confirmation by the auditor that an audit has taken place.

- for the bioanalytical part of a trial, OECD GLP § 2.2.1.f states under Responsibilities of Quality Assurance Personnel:
prepare and sign a statement, to be included with the final report, which specifies types of inspections and their dates, including the phase(s) of the study inspected, and the dates inspection results were reported to management and the Study Director and Principal Investigator(s), if applicable. This statement would also serve to confirm that the final report reflects the raw data.
§ 9.2.4. on the contents of the final report also states:
A Quality Assurance Programme statement listing the types of inspections made and their dates, including the phase(s) inspected, and the dates any inspection results were reported to management and to the Study Director and Principal Investigator(s), if applicable. This statement would also serve to confirm that the final report reflects the raw data.

So no specific requirement in the parent documents to have the statements signed by QA management rather than by the auditors themselves.

Regards
Ohlbe