The practice of invalidating OOS results is not new at Lupin Limited.

of invalidating-64of invalidating-73of invalidating-32

If this parameter is FALSE, the background remains unchanged.

If the function succeeds, the return value is nonzero. The invalidated areas accumulate in the update region until the region is processed when the next WM_PAINT message occurs or until the region is validated by using the Validate Rect or Validate Rgn function.

You should create a dedicated user account for use with replication agents.

For more information see the Configure Replication and Transport Users section of the Security Checklist.

Warning Letters are bothersome for the companies receiving them and usually force them to make elaborate adjustments to their GMP relevant processes.

Thanks to the Freedom of Information Act, the publicly available Warning Letters provide outsiders with a wealth of information regarding the issues FDA inspectors pay special attention to and show what traces they pursue in order to uncover GMP deficiencies.

Inspectors found violations of GMP regulations at both facilities, concerning the handling of OOS results and bulk hold times.

The individual deficiencies are described as follows: Invalidating of OOS results The release testing of an active pharmaceutical ingredient (API) intended for further processing showed the assay result to be out of specification.

This procedure was practiced at the QK laboratories of both facilities.

The test for content uniformity of tablets delivered an OOS result, due to which an investigation in the laboratory had been initiated.

The inspector's assessment was unmistakeable in this case: if an error in quality control can be ruled out, a root cause analysis must be conducted in the production area.