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Outsourced internal GMP & GVP Audits

Introduction

Multinational biotech

The French affiliate of a multinational Biotech company has its own QMS. Upon the QP responsibility, they conduct their internal audit with a 3-year plan (at the end of a 3 year cycle, they have audited all of their processes).

Apotech consultants 

2 External auditors

Both are lead certified auditors and have 20 years of experience in the pharma industry, at corporate level.

Types of Audits

  • GMP 
  • GVP

Audit Locations

  • France ​
Frame 1000005946

Scope of work

Done

One audit to be conducted per quarter

Done

The client provides all the templates

Done

Apotech has identified 2 auditors who will conduct the whole program, so that they become familiar with the client’s QMS and can cross check or cross reference the different findings along the audit program

Done

2024: training, PV, distribution, management review

Done

The client also designs the annual priorities

Done

Apotech designs the agenda and the duration of the audit on site

Done

Apotech provides assessment on the CAPA plan (if any)

Have a project in mind_ Let’s work together!
Client quote

Main take away: Having an external service provider to conduct the internal audit helps to take a fresh eye on the corporate practices and SOPs. It also helps to challenge the teams in their day-to–day activities.

Key numbers

Management

Team

2 Auditors

Charity

Location

France

Combo Chart

Length

3 Year

WeChat

Type

Work Packages

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