21 CFR Part 58 - Good Laboratory Practice (GLP)
Organization and Personnel (Subpart B)

21 CFR Part 58 - Good Laboratory Practice (GLP) 58.31: Testing Facility Management

Testing facility management must designate a Study Director, ensure a Quality Assurance Unit exists, ensure test and control articles are characterized, and that deviations are documented.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

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  • 211.22 Responsibilities of Quality Control Unit

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