6.3 - Production - Packaging and Labeling Operations Records & Recordkeeping communication and review of risks

communication and review of risks to the quality of the medicinal product

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

An out of specification investigation must be completed each time a laboratory test

Such reviews should normally be conducted and documented annually

6.3 - Production - Packaging and Labeling Operations Records & Recordkeeping communication and review of risksLabeling 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