8.5 - Laboratory Controls - Physical and Chemical Testing limit of quantification Labeling materials issued for a

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

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

Covers all sub-parts of GMP regulations 21 CFR 111 including personnel

and contamination

You must establish appropriate specifications of identity

8.5 - Laboratory Controls - Physical and Chemical Testing limit of quantification Labeling materials issued for aAppropriate physical and chemical tests or examinations must be performed by qualified personnel on representative samples of components, packaging, labels, in process materials, and drug products according to their established specifications to help determine if the specification for identity, strength, quality and purity is met