GAMP 5 - Good Automated Manufacturing Practice
Chapter 2: Key concepts (product and process understanding, life cycle within a QMS, scalable activities, science-based QRM, leveraging suppliers) – GAMP 5 - Good Automated Manufacturing Practice

GAMP 5 - Good Automated Manufacturing Practice 2.1.5: 2.1.5 Leveraging Supplier Involvement

Regulated companies should make maximum use of supplier knowledge, experience, documentation, records and testing throughout the system life cycle, subject to a satisfactory assessment of the supplier, rather than repeating activities the supplier has already performed under its own quality management system. Supplier involvement can extend to planning, requirements, specification, verification, operation, support and retirement, the justification for the reliance is documented, and the regulated company remains accountable for compliance and for the system being fit for the use intended however much of the work the supplier performs.

Maintained by Gerard BlokdykControl text last updated

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ISO 13485:2016 · 1 control

  • 7.4.3 Verification of purchased product

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in Chapter 2: Key concepts (product and process understanding, life cycle within a QMS, scalable activities, science-based QRM, leveraging suppliers) – GAMP 5 - Good Automated Manufacturing Practice

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The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.