13.0 - Warehouse Holding Requirements 111.23

13.0 - Warehouse Holding Requirements 111.23You must hold components and dietary supplements under appropriate conditions of temperature, humidity, and light so that their identity, purity, strength, and composition are not affected, and components, dietary supplements and labels in a manner that does not lead to their mix up, contamination, or deterioration

Sufficient space should be given to avoid mix-ups and cross-contamination

An out of specification investigation must be completed each time a laboratory test

dietary supplements

Failure to meet any specification must be investigated by Quality Control

Components and drug product containers and closures shall at all times be handled and stored in a manner to prevent contamination

and components

and Cosmetic Act (the act) apply to such terms when used in this part 21 CFR 211 for pharmaceuticals

to verify that the finished batch of dietary supplement meets established product specifications

in an unopened state

and contact surfaces you must take measures to exclude from any operations any person who in the opinion of a supervisor appears to have a health condition such as illness

You must quarantine materials and dietary supplements you receive before you use them in the manufacture of a dietary supplement until you collect representative samples of each unique lot and Quality control personnel review and approve the results of any tests or examinations conducted

calibration