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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

Scope of work

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

Done

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

Done

Compliance with the client standards and relevant legislation

Done

Development activities

Done

The current state of inspection readiness and compliance with regulatory expectations

Done

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

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Client quote

We have partnered with Apotech for 2 years now. They are a reliable service provider and we especially appreciate: 

  • How responsive they can be.
  • The highly skilled auditors they have in their teams.

 

Key numbers

Management

Team

GMP Lead Auditors

Charity

Location

Europe

Combo Chart

Length

Annual Contract

WeChat

Type

Work Package

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Are you searching for bespoke, flexible outsourced services for your Biotech or MedTech projects? Apotech offer a comprehensive range of consulting services for biologics, medical devices and other pharmaceutical products. Our extensive team of Regulatory, Quality and Engineering Consultants provide a world-class service to clients, large and small.