
Outsourced internal GMP & GVP Audits
Introduction
Multinational biotech
The French affiliate of a multinational Biotech company has its own QMS. Upon the QP responsibility, they conduct their internal audit with a 3-year plan (at the end of a 3 year cycle, they have audited all of their processes).
Apotech consultants
2 External auditors
Both are lead certified auditors and have 20 years of experience in the pharma industry, at corporate level.
Types of Audits
- GMP
- GVP
Audit Locations
- France

Scope of work

One audit to be conducted per quarter

The client provides all the templates

Apotech has identified 2 auditors who will conduct the whole program, so that they become familiar with the client’s QMS and can cross check or cross reference the different findings along the audit program

2024: training, PV, distribution, management review

The client also designs the annual priorities

Apotech designs the agenda and the duration of the audit on site

Apotech provides assessment on the CAPA plan (if any)

Key numbers

Team
2 Auditors

Location
France

Length
3 Year

Type
Work Packages