Are you verifying your methods under actual conditions of use?

A company recently received this 483 observation: 

 ….. The suitability of all testing methods is not verified under actual conditions of use.

 Specifically, your firm did not perform method verification for the …. USP Assay method and … EP Related Substance method before they were used for the testing of … drug products.  These products are submitted in the ANDA … as the registration batches.

In addition, your firm does not have a formal written procedure for conducting the method verification to ensure that the method was properly verified for the intended use.

For more observations pertaining to laboratory controls see Issue 1030 available today.  It also has observations pertaining to manufacturing controls, packaging and labeling controls and medical device manufacturing controls.

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