Prestataires de service et évaluation

Avec le recours accru à la sous-traitance, l'évaluation des prestataires de service est au coeur des enjeux et attentes réglementaires actuelles.

En effet, plusieurs textes réglementaires convergent dans ce sens ; pour n'en citer que quelques-uns :

Part 211.34 Consultants.

Consultants advising on the manufacture, processing, packing, or holding of drug products shall have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Records shall be maintained stating the name, address, and qualifications of any consultants and the type of service they provide.

Ou dans l'annexe 11 : 

3.1  When third parties (e.g. suppliers, service providers) are used e.g. to provide, install, configure, integrate, validate, maintain (e.g. via remote access), modify or retain a computerised system or related service or for data processing, formal agreements must exist between the manufacturer and any third parties, and these agreements should include clear statements of the responsibilities of the third party. IT-departments should be considered analogous.

3.2  The competence and reliability of a supplier are key factors when selecting a product or service provider. The need for an audit should be based on a risk assessment.

Récemment, une mise en demeure de la FDA à l'encontre d'une société de dispositifs médicaux pointe l'absence d'évaluation correcte de ces fournisseurs.

5.      Failure to adequately evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, and document the evaluation, as required by 21 CFR 820.50(a)(1).

Nous aurons l'occasion de développer ce sujet prochainement.