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
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