
GMP Audits
Introduction
UK Based Biotech
The company is a worldwide large biotech with a vast portfolio of biotech products (mainly oncology).
Apotech auditors:
3 auditors are involved in this partnership.
Types of Audits
- Contracts/agreements between the clients and the provider
- GMP/GDP
- Client SOPs
- Local regulations
Audit Locations
- Europe
The audited sites are:
- Client manufacturing sites
- CDMOs (APIs, Packaging suppliers, Drug Products)
5 audits are conducted on average per year

Scope of work
Apotech conducted GMP and/or GDP audits on the client request to assess:

The adequacy and effectiveness of internal controls and data integrity at the time of the review

Compliance with the client standards and relevant legislation

Development activities

The current state of inspection readiness and compliance with regulatory expectations

Compliance with the service agreement (contract) and with the scope of work

Key numbers

Team
GMP Lead Auditors

Location
Europe

Length
Annual Contract

Type
Work Package