10.1 - Laboratory Overview 111.355 shall be worn as necessary

shall be worn as necessary to protect drug products from contamination

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

Quality Control laboratories should be separated from production areas and should be designed to suit the operations to be carried out in them

A qualified person must review all product complaints received from consumers

or 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records

10.1 - Laboratory Overview 111.355 shall be worn as necessaryYou must use adequate laboratory facilities to perform whatever testing and examinations are necessary to determine that specifications are met. You must establish appropriate specifications of identity, purity, composition, and strength, and sampling plans for obtaining representative samples for testing and reserve