GAMP 5 - Good Automated Manufacturing Practice
Chapter 7: Supplier activities (products, applications, services and the supplier good practices) – GAMP 5 - Good Automated Manufacturing Practice

GAMP 5 - Good Automated Manufacturing Practice 7.3: Supplier Quality Management System

What does 7.3 require?

Suppliers should work under a QMS, ideally grounded in recognised standards, that sets out: how products are delivered and supported; how customer needs are understood and business, quality and regulatory requirements captured; who is responsible for what, with quality assurance holding authority separate from development, support, finance and marketing; the deliverables; how documents, records and information are managed; scheduled QMS reviews and internal audits; how incidents, problems and nonconformities are handled; and how the organisation keeps improving, including by taking up current development models and tools. The QMS rests on a life cycle concept, any sound life cycle (Agile among them) being acceptable, and contains procedures for managing and releasing software, controlling development changes, configuration management, traceability, training staff, managing documents and records, and backup and restore. Supporting documentation for software products is used through the life cycle, custom modules are documented in full, and industry guidance informs but never overrides the supplier's own QMS.

Maintained by Gerard BlokdykControl text last updated

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ISO 13485:2016 · 1 control

  • 4.1 General requirements

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Other controls in Chapter 7: Supplier activities (products, applications, services and the supplier good practices) – GAMP 5 - Good Automated Manufacturing Practice

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