Following a warning letter evaluation done by the European Compliance Academy (ECA) for warning letters issued in 2009 it was found that the most frequent deviations refer to the US CFR chapter 211.192 (Production record review), followed by 211.22 (Responsibilities of quality control unit), 211.60 (Laboratory controls), and 211.100 (Written procedures).

It becomes obvious from those warning letters that it still is a big problem for the pharmaceutical manufacturers how to deal the right way with recognized deviations.

In most cases deviations are recognized and recorded by the firms in a correct and accurate way. Anyway – the follow up, especially the actions necessary to find out more about the reasons of the deviations as well the measures necessary to be taken to avoid  repetition of such deviations in most cases are missing. But recording and evaluation of deviations today is not sufficient anymore and not in compliance with the current Good Manufacturing Practices. A formal CAPA – Corrective Action Preventive Action – procedure laid down and described in detail within a SOP is required by the Authority. There must be a formal procedure on how to follow up, how to do  root cause analysis and how to define preventive actions. All activities needs to be recorded for later back tracing as needed. Responsibilities for each action must clearly be defined.

If you want to learn more about CAPA or if you need some support in setting up such a system please contact Cobby Zhang on c-zhang@gemro-services.com or on phone: +86 20 8736 5457.

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