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Drug Manufacturing Inspections
New Compliance Program Guidance Manual 7356-002 from FDA

  On the PDA Conference in Sep 2001 in Washington, R.L. Friedman, Office of Compliance, CDER presented official numbers from FDA for the year 2000.

Out of 248 inspections 135 had been at API manufacturers.

Regarding recalls a steep increase had been seen over the last two years, during which also a shift had occurred. Most recalls hand been initiated by the FDA and not by industry. Since 1997 by far most of the recalls had been related to GMP-deviations, followed by lack of sterility assurance, lack of potency, dissolution problems and problems with analytical method validation.

  This has lead the FDA to change its inspectional approach to a "Quality System based Inspections" already known from the Center for Devices and Radiological Health (CDRH): "Quality Systems Inspection Technique", August 1999, see (htm)
The Quality System of the company will be at the focus during the new inspections.

Keeping pharmaceuticals sterile and effective is an underlying goal in the record $1.4 billion budget the House recently provided for the US-FDA. $ 10.3 million has been allocated to prevent substandard healtch care products from reaching the U.S. market by increasing plant inspections.


03 feb 2002 / SB

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03 feb 2002 SBConsult ApS