Warning Letters 2002: The Top 10 Complaints Regarding 21 CFR § 211

GMP News No. 299

GMP News
2 April 2003
 

Warning Letters 2002:
The Top 10 Complaints Regarding 21 CFR § 211

 
The Warning Letters issued by FDA in the past year were analysed with regard to complaints concerning Part 211 of the Code of Federal Regulations, which lays down the "current good manufacturing practices for finished pharmaceuticals." From the analysis of these 21 CFR 211 topics, we have generated a top ten list of the most frequent deficiencies that provides a very informative image of the points at which FDA is having an especially close look these days.

With 30 Warning Letters, "Written procedures; deviations" ranks first, followed by "Testing and release for distribution" and "Responsibilities of the quality control unit" with 28 and 27 WLs respectively. Then come "Laboratory controls - General requirements," "Production record review," and "Batch production control records" with 24, 22, and 20 WLs.

From this list, one can deduce that FDA carries on inspecting especially the quality control departments according to its system-based approach. In doing so, the Authority's main questions are:

  • Do written procedures exist for all quality-relevant controls? How are deviations handled?
  • In which way are batch test and release conducted?
  • How does the quality control unit fulfil its responsibilities?
  • Are the general requirements to quality control laboratories fulfilled?
  • What do the batch-related production and control records look like? Are they checked appropriately?

These are still the points where most deviations are found.

Other topics that have become the focus of FDA's attention refer to:

  • personnel qualification (18 WLs)
  • cleaning and maintenance of production equipment (17 WLs)
  • stability testing (15 WLs)
  • sampling and testing of in-process materials and drug products (14 WLs)

The following graph shows the ranking of the individual references to 21 CFR § 211 from 2002 (percentage of WLs in relation to the sum of the 10 most frequent citations; absolute figures in parentheses).

The following events focus especially on FDA requirements:

Author:
Dr Gerhard Becker
CONCEPT HEIDELBERG

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