Sub-Part J - Laboratory Operations

10.8 - Laboratory Method Validation

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You must verify that the laboratory examination and test methods are appropriate for their intended use for each supplement or drug. You must identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required. Non-pharmacopeial, in-house methods must be validated, see ICH Q2(R2).

Lab icons created by smashingstocks - Flaticon
Smiling lab technician in white coat pointing at a test tube with orange liquid versus a choice of three standards blue, green and orange to validate a test method