21 CFR 58.81 - Standard operating procedures.
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(a) A testing facility shall have standard operating procedures in writing setting forth nonclinical laboratory study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study. All deviations in a study from standard operating procedures shall be authorized by the study director and shall be documented in the raw data. Significant changes in established standard operating procedures shall be properly authorized in writing by management.
(3) Receipt, identification, storage, handling, mixing, and method of sampling of the test and control articles.
(4) Test system observations.
(c) Each laboratory area shall have immediately available laboratory manuals and standard operating procedures relative to the laboratory procedures being performed. Published literature may be used as a supplement to standard operating procedures.
(d) A historical file of standard operating procedures, and all revisions thereof, including the dates of such revisions, shall be maintained.
[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987]
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.