![image (3) image (3)](https://apotechconsulting.com/wp-content/uploads/bb-plugin/cache/image-3-circle-3f60d2fc389527990d597a195eebd143-8hmktdenvb2i.webp)
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
![Frame 1000005946 Frame 1000005946](https://apotechconsulting.com/wp-content/uploads/Frame-1000005946.png)
Scope of work
Apotech conducted GMP and/or GDP audits on the client request to assess:
![Done Done](https://apotechconsulting.com/wp-content/uploads/Done.png)
The adequacy and effectiveness of internal controls and data integrity at the time of the review
![Done Done](https://apotechconsulting.com/wp-content/uploads/Done.png)
Compliance with the client standards and relevant legislation
![Done Done](https://apotechconsulting.com/wp-content/uploads/Done.png)
Development activities
![Done Done](https://apotechconsulting.com/wp-content/uploads/Done.png)
The current state of inspection readiness and compliance with regulatory expectations
![Done Done](https://apotechconsulting.com/wp-content/uploads/Done.png)
Compliance with the service agreement (contract) and with the scope of work
![Have a project in mind_ Let’s work together! Have a project in mind_ Let’s work together!](https://apotechconsulting.com/wp-content/uploads/Have-a-project-in-mind_-Lets-work-together.png)
Key numbers
![Management Management](https://apotechconsulting.com/wp-content/uploads/Management.png)
Team
GMP Lead Auditors
![Charity Charity](https://apotechconsulting.com/wp-content/uploads/Charity.png)
Location
Europe
![Combo Chart Combo Chart](https://apotechconsulting.com/wp-content/uploads/Combo-Chart.png)
Length
Annual Contract
![WeChat WeChat](https://apotechconsulting.com/wp-content/uploads/WeChat.png)
Type
Work Package