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 7.1: Supplier Products, Applications and Services

What does 7.1 require?

Supplier involvement varies with what is supplied: for a standard product bought off the shelf with at most factory-provided parameter ranges, involvement is typically limited to documentation, training, support and maintenance, with the product developed and maintained under good practices; for a configured product the supplier typically supports specification, configuration, verification and operation under procedures agreed with the regulated company and documented in the plan; for a custom application the supplier is contracted to develop against defined requirements and is involved through the full project life cycle and operational support; and for service provision, including cloud services, the supplier operates within a QMS with quality planning that defines activities, procedures, deliverables and responsibilities for delivering and monitoring the service, approved by both parties, which may be satisfied by a service level agreement. Consultants acting as implementation partners have sufficient education, training and experience for their subject.

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