26/27 January 2021
GMP News No. 690
16 March 2006
|Media Fills in the Centre of US FDA Warning Letters|
An annual FDA Warning Letter Report is published by the ECA in cooperation with Concept Heidelberg the 2005 report will be issued shortly. The following concentrates on early trends.
As last year already, the paragraph 21 CFR 211.113 "Control of microbiological contamination" is under the top Ten. While this paragraph was listed as number 6 in 2004, it ranked third this time.
What does this paragraph mean? It requires written procedures to prevent microbial contaminations in not sterile and sterile formulations. It also requires the validation of the sterilisation processes.
The FDA warning letter report contains overall 8 citations relative to 21 CFR 211.113. However, a citation can comprise several deficiencies. Therefore, the following detailed evaluation mentions more listed deficiencies than the actual 8 citations:
Deficiencies relative to qualification and validation aspects are mentioned quite often, but most frequent are mentions with regards to media fills deficiencies. They directly influence the validation of the aseptic process. The agency directly referenced an incorrect PQ when a sterilisation process was evaluated inadequate. The qualification of clean rooms pertained to insufficient "smoke studies." Reason for design deficiencies for tanks is insufficient DQ. Further mentioned deficiencies related to unsatisfactory filter validation.
The following European Compliance Academy (ECA) education courses relate to this area:
Monitoring Compliant and Reasonable,
Validation Manager, 3-Day GMP Education Course,
Source: FDA Warning Letter Report (will be published shortly)