Continuing Trend: Again, Numerous Warning Letters issued to European API Manufacturers

The analysis of the first 9 months of fiscal year 2012 regarding the number of Warning Letters (WL) issued by the FDA to pharmaceutical API manufacturers shows a significant trend: among the 8 deficiencies observed between October 2011 and June 2012, only one letter has been issued to a U.S. American company. The remaining 7 letters have been sent to companies in the following countries: 

  • Germany: 2 WLs (one of them contains complaints related to production sites located in France (2) and Italy (1).)
  • Poland: 1 WL
  • Spain: 1 WL
  • Mexico: 3 WLs

Most of the GMP deficiencies have been found in the area of analytics. This tendency had already been observed in previous Warning Letters sent to API manufacturers. The use of unsuitable laboratory instruments, the GMP non-compliant handling of raw data, the lack of appropriate analytical processes as well as the requirements for investigating OOS-results, and the inadequate management of reference standards have been mainly objected.

Another group of complaints can be summarized by the keyword "Cross Contamination". The buildings and facilities inspected haven't complied with the GMP understanding of the FDA investigators. The respective citations from the WL have been summarised as follows:

  • Failure to have an adequate maintenance procedure to prevent contamination or carry-over of a material that would alter the quality of the API.
  • Failure to use dedicated production areas, including facilities and air handling equipment, and process equipment.
  • Failure to use dedicated production areas, including facilities and air handling equipment, when performing operations with beta-lactam products.
  • Your firm failed to establish procedures to adequately clean and store equipment und utensils to prevent contamination or carry-over of material that would alter the API beyond the established specifications.
  • Failure to maintain buildings and equipment used in the manufacture of intermediates and active pharmaceutical ingredients

You can find a detailed analysis of the Warning Letters addressed to API manufacturers for fiscal year 2011 in our News from 18 January 2012.

CONCEPT HEIDELBERG has been collecting and analysing the FDA Warning Letters to manufacturers of medicinal products, blood and blood processing products as well as of APIs for the past 10 years. Centrepieces of the annual analysis are the excerpts from the original Warning Letters. These excerpts were shortened for reading reasons, but still convey the context in which the GMP deficiency was found.

The Warning Letters Report for the fiscal year 2011 is available. It is part of the complete analysis of the past 10 years which can be purchased as CD "FDA Navigator" for 399,- €.  The CD also comprises all GMP relevant FDA Guidelines.

Author:
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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