§111.320. What requirements apply to laboratory methods for testing and examination?
21 C.F.R. § 111.320
You must verify that the laboratory examination and testing methodologies are appropriate for their intended use.
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.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264.
Source
Source: 72 FR 34942, June 25, 2007, unless otherwise noted.