General Provisions:
A) The regulation applies to dietary supplements manufactured for another person.
B) The regulation applies to dietary supplements that are imported or offered for import.
C) The regulation does not apply to holding of dietary supplements in a retail establishment for direct sale to consumers.
D) All of the above.
Personnel: Microbial Contamination
A) Management must take measures to exclude employees from CGMP operations who might be a source of microbial contamination.
B) Employees need not be instructed to notify their supervisor if they have a medical condition that could contaminate components, supplements, contact surfaces.
C) Employees do not need to wear outer protective garments, such as gowns, when working in production areas.
D) None of the above.
Physical Plant and Grounds
A) Grounds surrounding the plant do not need to be maintained to protect against contamination.
B) Cleaners and sanitizers may be stored essentially anywhere in the plant without any special identification or security.
C) There is no requirement to have a pest control SOP.
D) Hand-washing facilities must be adequate, convenient, and provide running water at a suitable temperature.
Specifications: Dietary Ingredients
A) Dietary ingredients can be used based on a Certificate of Analysis from the supplier only.
B) At least one test to verify identity of the dietary ingredient must be done by the manufacturer.
C) All suppliers of dietary ingredients must be subjected to an on-site audit before such materials can be used.
D) Dietary ingredient manufacturers must comply with all requirements of 21 CFR Part 111, Dietary Supplement Good Manufacturing Regulations.
Material Reviews: Documentation must
A) Include signatures of the persons participating in the review.
B) Include cause of the problem and corrective/preventive actions.
C) Be included in the appropriate batch production record.
D) All of the above.
Dietary Supplement Components
A) Each lot of components must be identified with a unique lot number to allow for traceability to the supplier, date received, name of component, status and to the dietary supplement in which it was used.
B) All components must be quarantined until they have been sampled and Quality Control has reviewed and approved the tests and examinations conducted and released them for use in manufacturing.
C) All components must be stored under conditions that will protect them from contamination and deterioration.
D) All of the above.
Equipment and Utensils: Calibration of Instruments and Controls Must:
A) Be calibrated before first use.
B) At a frequency specified in writing by the manufacturer of the instrument or control or at routine intervals as necessary to ensure the accuracy and precision of the instrument or control.
C) Be calibrated in accordance with established written calibration procedures.
D) All of the above
Holding:
A) Components and supplements must be held under appropriate environmental conditions to ensure their quality is not affected.
B) Packaging and labels must be held under appropriate conditions so they are not adversely affected.
C) In-process materials must be held under conditions that will protect them against mix-ups, contamination, and deterioration.
D) All of the above.
Master Production Records: must
A) Have the name of the dietary supplement to be manufactured and the strength, concentration, weight or measure of each ingredient for each batch size.
B) A complete list of components to be used.
C) An accurate statement of the weight or measure of each component to be used.
D) All of the above.
Laboratory Operations:
A) You must provide adequate lab facilities for testing whether components, in-process materials, and finished products meet specifications.
B) Part 111 requirements apply to both in-house and contract labs.
C) If analyses are performed by an outside lab, you are responsible for ensuring they are adequately performed.
D) All of the above.
