Are you evaluating their capabilities prior to using them?
An API facility recently received this 483 observation:
…..Contract laboratories are not evaluated to ensure GMP compliance.
Specifically, your firm has repeatedly demonstrated that you have no assurance in the capability of your contract laboratories to perform testing that ensures compliance with established specifications and standards. For example:
a. API ….., lot ….., was sent to ….. for potency testing. The result was …..%, which is above the specification. ….. uses a ….. method for potency testing; however they also tested lot ….. with the method, obtaining a result of ….., which confirmed the initial OOS result. Your firm’s investigation of this OOS states that “in distrust of (….. methods of analysis), your firm sent an additional sample of lot ….. to ….. for analysis. This result was returned within specification; however, there is no evidence to suggest that the results obtained by the first lab are invalid. ….., lot ….., was released.
For more details on this observation as well as other observations pertaining to Active Pharmaceutical Manufacturers see Issue 1015 available today. It features observations from API Manufacturers on our rotating page 3 topic as well as Laboratory Controls and Medical Device Manufacturing Controls.