Suppliers and Service Providers

Computer service providers should be evaluated before use in a GMP environment.

Text of Annex 11 Section 3 Suppliers and Service Providers

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.
3.3 Documentation supplied with commercial off-the-shelf products should be reviewed by regulated users to check that user requirements are fulfilled.
3.4 Quality system and audit information relating to suppliers or developers of software and implemented systems should be made available to inspectors on request.

Interpretation

Use contracts, Service Level Agreements, and work instructions to define contractor roles. Suppliers should be evaluated before use. The type of audit should be based on risk associated with the service provided. Quality should review and approve supplier documentation before it is used in GMP operations. Supplier Quality audits should be public to external regulatory auditors.

Implementation

There should be a Supplier Quality program.

Frequently Asked Questions

Q: Do we have to audit every one of our suppliers?
A: Suppliers should be evaluated before use, but that does not necessarily mean you need an on-site audit for every piece of software you purchase. Depending upon system risk, business criticality, and the program history within your organisation, you may decided to do an on-site audit, do a paper review of their quality systems, or perform no review at all.

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