§111.113. What quality control operations are required for a material review and disposition decision?
21 C.F.R. § 111.113
Quality control personnel must conduct a material review and make a disposition decision if:
A specification established in accordance with § 111.70 is not met;
A batch deviates from the master manufacturing record, including when any step established in the master manufacturing record is not completed and including any deviation from specifications;
There is any unanticipated occurrence during the manufacturing operations that adulterates or may lead to adulteration of the component, dietary supplement, or packaging, or could lead to the use of a label not specified in the master manufacturing record;
Calibration of an instrument or control suggests a problem that may have resulted in a failure to ensure the quality of a batch or batches of a dietary supplement; or
A dietary supplement is returned.
When there is a deviation or unanticipated occurrence during the production and in-process control system that results in or could lead to adulteration of a component, dietary supplement, or packaging, or could lead to the use of a label not specified in the master manufacturing record, quality control personnel must reject the component, dietary supplement, packaging, or label unless it approves a treatment, an in-process adjustment, or reprocessing to correct the applicable deviation or occurrence.
When a specification established in accordance with § 111.70 is not met, quality control personnel must reject the component, dietary supplement, package or label, unless quality control personnel approve a treatment, an in-process adjustment, or reprocessing, as permitted in § 111.77.
The person who conducts a material review and makes the disposition decision must, at the time of performance, document that material review and disposition decision.
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.