5.0 - Specifications and Process Control 211.94 or holding of a drug

or holding of a drug product shall wear clean clothing appropriate for the duties they perform

one investigation per OOS test parameter

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

of materials or drug product must be examined visually for appropriate labeling as to contents

5.0 - Specifications and Process Control 211.94 or holding of a drugYou must establish a specification for identity, purity, strength, and composition of the dietary supplement at any point, step, or stage in the manufacturing process where this is necessary to ensure its quality and that it is packaged and labelled as specified in the manufacturing record MMR. Such specifications must be met