§ 111.325
21 CFR Part 111 · Subpart J Production and Process Control System: Requirements for Laboratory Operations
§ 111.325 Under this subpart J, what records must you make and keep?
(a) You must make and keep records required under this subpart J in accordance with subpart P of this part.
(b) You must make and keep the following records:
(1) Written procedures for laboratory operations, including written procedures for the tests and examinations that you conduct to determine whether specifications are met;
(2) Documentation that laboratory methodology established in accordance with this subpart J is followed.
(i) 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.
(ii) The documentation for laboratory tests and examinations must include the results of the testing and examination.
← Previous§ 111.320 What requirements apply to laboratory methods for testing and examination?Next →§ 111.353 What are the requirements under this subpart K for written procedures?
Back to 21 CFR Part 111 contents