21 CFR 111.113: What quality control operations are required for a material review and disposition decision?
Requires quality control personnel to review and make documented disposition decisions when specifications are unmet, batches deviate, adulteration occurs, calibration fails, or products are returned, rejecting material unless approved treatment or reprocessing corrects it.
Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements · Subpart F, Production and Process Control System: Requirements for Quality Control
Recent 483s citing 111.113
- Aspire Pharmaceuticals Inc. · Somerset, New JerseyFeb 3, 2022
- BLA Enterprises, LLC · Lakewood, ColoradoDec 8, 2016
- Primrose Candy Company · Chicago, IllinoisYour quality control personnel did not reject a component for which a specification… May 23, 2012
The regulation text
§ 111.113 What quality control operations are required for a material review and disposition decision?.
(a)Quality control personnel must conduct a material review and make a disposition decision if:
(1)A specification established in accordance with § 111.70 is not met;
(2)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;
(3)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;
(4)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
(5)A dietary supplement is returned.
(b)(1) 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.
(2)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.
(c)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.
Questions
What does 21 CFR 111.113 require?
Requires quality control personnel to review and make documented disposition decisions when specifications are unmet, batches deviate, adulteration occurs, calibration fails, or products are returned, rejecting material unless approved treatment or reprocessing corrects it.
Which sections are cited alongside 111.113?
In the same 483s, investigators most often also cite 211.110 (Sampling and testing of in-process materials and drug products), 211.192 (Production record review), 111.210 (What must the master manufacturing record include?), 111.560 (What requirements apply to the review and investigation of a product complaint?).