GxP Audits – Worldwide
Introduction
Global Biopharmaceutical
Our client is a global biotechnology company dedicated to novel treatments for patients through inhibition of protein kinases to fight cancer. They are Headquartered in the US, with a large footprint in the EU.
Types of Audits
- GCP – For Cause / Investigator / Phase 1 unit
- GCLP – Central labs / Bioanalytical labs
- GLP – Testing / Analytical
- GVP – Affiliates / QPPV / LSO
- GMP – CMO Qualification
- Biostatistics / Data Management
Audit Locations
- USA (12 states)
- Canada
- China
- Singapore
- France
- UK
- Belgium
- Hungary
- Germany
- Sweden
- Australia
- South Korea
- Ireland
- Poland
- Romania
Scope of work
Solely responsible for conducting our client’s full yearly audit program;
Audits range across GxP, covering 15 countries and 12 USA states;
Conduct of the audit, initial meeting, interviews with key members of the site, review of documentation & exit meeting;
42 audits across 2023;
Apotech Auditors liaising directly with vendors and sites to arrange dates and pre-audit meetings;
Audit report after 21 days and issue of Audit Certificate;
Involved in planning the clients audit schedule for the following year.
Key numbers
Team
23 auditors
Location
Worldwide
Length
2 Year Contract
Type
Full Service Provision