Batch number, lot number, or control number – any distinctive group of letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacturing, packaging, labeling, and/or holding of a batch or lot of dietary supplements can be determined.
Contact surface – any surface that contacts a component or dietary supplement, and those surfaces from which drainage onto the component or dietary supplement, or onto surfaces that contact the component or dietary supplement, occurs during the normal course of operations. Examples of contact surfaces include containers, utensils, tables, contact surfaces of equipment, and packaging.
In-process material – any material that is fabricated, compounded, blended, ground, extracted, sifted, sterilized, derived by chemical reaction, or processed in any other way for use in the manufacture of a dietary supplement.
- May have public health significance;
- May cause a component or dietary supplement to decompose;
- Indicate that the component or dietary supplement is contaminated with filth; or
- Otherwise may cause the component or dietary supplement to be adulterated.
Must is used to state a requirement.
Physical plant – all or any part of a building or facility used for or in connection with the manufacturing, packaging, labeling, or holding a dietary supplement.
Product complaint – any communication that contains any allegation, written, electronic, or oral, expressing concern, for any reason, with the quality of a dietary supplement, that could be related to current good manufacturing practice. Examples of product complaints are: Foul odor, off taste, illness or injury, disintegration time, color variation, tablet size or size variation, under-filled container, foreign material in a dietary supplement container, improper packaging, mislabeling, or dietary supplements that are superpotent, subpotent, or contain the wrong ingredient, or contain a drug or other contaminant (e.g., bacteria, pesticide, mycotoxin, glass, lead).
Quality control – a planned and systematic operation or procedure for ensuring the quality of a dietary supplement.
Quality control personnel – any person, persons, or group, within or outside of your organization, who you designate to be responsible for your quality control operations.
Reprocessing – using, in the manufacture of a dietary supplement, clean, uncontaminated components or dietary supplements that have been previously removed from manufacturing and that have been made suitable for use in the manufacture of a dietary supplement.
Reserve sample – a representative sample of a product that is held for a designated period of time.