21 CFR 111.325 - Under this subpart J, what records must you make and keep?

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§ 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.

Title 21 published on 2014-04-01

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