5.0 - Specifications and Process Control 211.94

5.0 - Specifications and Process Control 211.94You 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

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

covered by a marketing authorisation

Labeling materials issued for a batch shall be carefully examined for identity and conformity to the labeling specified in the master or batch production records

you must maintain adequate personal cleanliness

one investigation per OOS test parameter

Upon receipt

and is capable of operating satisfactorily within the operating limits required by the process

and proper operations

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

containers

Glossary of the definitions and interpretations of the terms found in section 201 of the Federal Food

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