6.3 - Production - Packaging and Labeling Operations Records & Recordkeeping Compendial methods taken from USP

Compendial methods taken from USP

Microbiological pharmacopeia methods are considered to have been validated however the performance criteria and the suitability for each product type must be verified

for example AOAC

experience with the process and ultimately links to the protection of the patient

6.3 - Production - Packaging and Labeling Operations Records & Recordkeeping Compendial methods taken from USPLabeling materials issued for a batch shall be carefully examined for identity and conformity to the labeling specified in the master or batch production records. Procedures shall be used to reconcile the quantities of labeling issued, used, and returned, and shall require evaluation of discrepancies found