Independent EU GMP and GDP audits

How it runs

1. 01

   Audit Scoping

   With you, we settle why the site needs an audit, then the scope, the criteria, the dates and what you need to receive.

2. 02

   Documentation Review

   We review the site’s quality documents, audit history and data, so the audit looks where the risk is.

3. 03

   Audit Planning

   We turn the scope into an audit plan and settle the agenda, interviews, sampling and access with the site.

4. 04

   Audit Execution

   On site we assess systems and processes, interview staff, sample records and collect objective evidence.

5. 05

   Conclusions & Reporting

   We present our conclusions at the closing meeting, grade each finding and issue the final report.

6. 06

   CAPA Follow-Up

   If the follow-up is in scope, we review the CAPA response and its evidence and tell you which findings are closed.