Are you verifying your analytical 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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GMP TRENDS is a publication for the pharmaceutical and medical device industries, trending observations made by FDA investigators during GMP inspections throughout the world.

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To get the most out of GMP Trends®, sign up to one of our subscription packages for valuable, up-to-date information you won't find anywhere else! Every subscription provides the most frequently cited FDA 483 observations taken from recent FDA Inspections. The non-essential information is redacted to streamline the facts in an easily readable format. Join the thousands of professionals who rely on GMP Trends® to keep them informed of the latest FDA Enforcement Trends!

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