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An out of specification investigation must be completed each time a laboratory test
Microbiological pharmacopeia methods are considered to have been validated however the performance criteria and the suitability for each product type must be verified
There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components
Such reviews should normally be conducted and documented annually
6.3 - Production - Packaging and Labeling Operations Records & Recordkeeping An out of specification investigationLabeling 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
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