§111.325. Under this subpart J, what records must you make and keep?
21 C.F.R. § 111.325
You must make and keep records required under this subpart J in accordance with subpart P of this part.
You must make and keep the following records:
Written procedures for laboratory operations, including written procedures for the tests and examinations that you conduct to determine whether specifications are met;
Documentation that laboratory methodology established in accordance with this subpart J is followed.
The person who conducts the testing and examination must document, at the time of performance, that laboratory methodology established in accordance with this subpart J is followed.
The documentation for laboratory tests and examinations must include the results of the testing and examination.
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.