Interesting APIC/CEFIC Guideline for the Qualification of Contract Laboratories

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7/8 May 2024

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Already some time ago, the APIC has published a guideline for the qualification of contract laboratories. Although this interesting Guide was already published in 2012 it is not well known in industry. The guideline is supposed to define uniform requirements for the "life cycle management" of contract laboratories. In addition  the APIC had already prepared a guideline for the management of suppliers with a focus on the suppliers of materials a manufacturer of active ingredients needs. But it became clear that another guideline specifically for contract laboratories was needed.
 
This guideline covers the entire process from the identification of contract laboratories to the "ongoing monitoring".
 
The guideline is divided into four main chapters:
1. Identification of contract laboratories
2. Risk assessment
3. Evaluation of the quality
4. Further review following the adoption of the contract laboratory
 
Interesting aspects are e.g. a flow chart depicting the entire process, a detailed checklist for the selection of the contract laboratory, a detailed questionnaire to assess the contract laboratory, and, in Annex 3 (Risk Assessment), specific proposals for how the service and the performance of a laboratory can be evaluated.
 
This guideline is not well known in the pharmaceutical industry, but it is of interest for all those who are involved in selecting and dealing with contract laboratories.
 
Please see the full APIC Guideline for Qualification & Management of Contract Quality Control Laboratories for more detailed information.