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