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

GMP News No. 299

2 April 2003

WarningLetters 2002:
The Top 10Complaints Regarding 21 CFR § 211

The Warning Letters issued by FDA in the past year were analysed withregard to complaints concerning Part 211 of the Code of FederalRegulations, which lays down the "current good manufacturingpractices for finished pharmaceuticals." From the analysis of these21 CFR 211 topics, we have generated a top ten list of the most frequentdeficiencies that provides a very informative image of the points at whichFDA is having an especially close look these days.

With 30 Warning Letters, "Written procedures; deviations" ranksfirst, followed by "Testing and release for distribution"and "Responsibilities of the quality control unit" with28 and 27 WLs respectively. Then come "Laboratory controls -General requirements," "Production record review," and "Batchproduction control records" with 24, 22, and 20 WLs.

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

  • Do written procedures exist for all quality-relevant controls? Howare 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 laboratoriesfulfilled?
  • 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 (14WLs)

The following graph shows the ranking of the individual references to21 CFR § 211 from 2002 (percentage of WLs in relation to the sum of the10 most frequent citations; absolute figures in parentheses).

Dr Gerhard Becker


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