During the process of drug manufacturing, it is critical that the products are not contaminated from outside sources, such as personnel.
For these reasons, Section 211.28 states that:
(a) Personnel 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.
Overall cleanliness is of the utmost importance during all aspects of the drug manufacturing process.
So, let’s discuss sanitation and authorized access next.