§211.111. Time limitations on production.
21 C.F.R. § 211.111
When appropriate, time limits for the completion of each phase of production shall be established to assure the quality of the drug product. Deviation from established time limits may be acceptable if such deviation does not compromise the quality of the drug product. Such deviation shall be justified and documented.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 321, 351, 352, 355, 360b, 360ddd, 360ddd-1, 371, 374; 42 U.S.C. 216, 262, 263a, 264.
Source
Source: 43 FR 45077, Sept. 29, 1978, unless otherwise noted.