GAMP 5 - Good Automated Manufacturing Practice
Chapter 6: Regulated company activities (governance and system-specific activities) – GAMP 5 - Good Automated Manufacturing Practice

GAMP 5 - Good Automated Manufacturing Practice 6.2.1: 6.2.1 Identify Compliance Standards

For each system the regulated company identifies the compliance standards that apply: compliance and fitness for intended use are achieved in accordance with the company's own policies and procedures; reference may be made to national and international standards, and industry guidance such as GAMP is used as supporting information within the context of those policies and procedures rather than as a mandatory rule set. The applicable GxP regulations and any other regulations are identified so that requirements and verification can be traced to them.

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ISO 13485:2016 · 1 control

  • 7.2.1 Determination of requirements related to product

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Other controls in Chapter 6: Regulated company activities (governance and system-specific activities) – GAMP 5 - Good Automated Manufacturing Practice

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