Drugs

CGMP Violations at BBT Biotech

A 5/4-7/15 FDA inspection at the BBT Biotech Gmbh drug manufacturing facility in Baesweiler, Germany, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API). A 5/16 Warning Letter says that specific deviations included:

failing to follow a documented, on-going stability testing program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates;
failing to establish and follow a change management system evaluating all changes that could affect the production and control of APIs and failing to evaluate the potential effect changes may have on API quality;
failing to adequately investigate out-of-specification results; and
failing to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and to provide adequate controls to prevent omission of data.

The letter acknowledges commitments to improvement made by the company but says its responses to the inspection observations were inadequate. It lists specific steps the company should take and information it should provide.

The company was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with documentation of each step and a time for completion.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome