2.3 - Personnel Hygiene 111.155

2.3 - Personnel Hygiene 111.155Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination. Personnel shall practice good sanitation and health habits

and distributors

independent from Production to permit the satisfactory operation of Quality Control

You must fill

and drug products designed to ensure that each lot number conforms to appropriate standards of identity

You must prepare a batch production record every time you manufacture a batch of a dietary supplement including complete information relating to the production and control of each batch

You must take all the necessary precautions during the manufacture of a dietary supplement to prevent contamination of components or dietary supplements

drug product containers

You must calibrate before first use

the potential for the trash to attract

performed maximum annually once the drug is marketed

to ensure uniformity in every finished batch and that it meets its specification

Quality control personnel must review and approve these decisions and approve the findings and follow-up action of any investigation performed