§ 111.320
21 CFR Part 111 · Subpart J Production and Process Control System: Requirements for Laboratory Operations
§ 111.320 What requirements apply to laboratory methods for testing and examination?
(a) You must verify that the laboratory examination and testing methodologies are appropriate for their intended use.
(b) You must identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required to determine whether the specification is met.
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