Results of ECA´s Validation Survey regarding the revision of Annex 15

With the finalisation of the new FDA Guidance on Process Validation in 2011, a validation life cycle has become state of the art. Accordingly it is planned to partly revise the process validation approach in Europe as well. The European Medicines Agency (EMA) has already issued a concept paper with regard to the EU Annex 15 and asked for comments; Reason enough for the ECA to set up a survey to find out the industry’s thoughts on the planned revision (see ECA GMP-News from 20 March 2013).


Altogether, 290 respondents provided feedback. However, not all respondents did answer all questions. But the fact that some of the questions was skipped by the majority is also a statement and leaves room for interpretation.

The results are quite surprising. Most of the respondents (altogether 287) are moving in a new direction towards to modern process validation approach. More than 90% would like to have a process validation life cycle. Otherwise more than 75% would like to keep the DQ-PQ concept, but with a clarification of the PQ requirements (97%). Asked for alternatives more than half (53%) of the 57 respondents mainly preferred ASTM E2500.

From the 264 of those respondin to the question, 63% would like to see the 3-batch approach embedded in the revised Annex 15. Moreover, according to the majority (253 respondents) the revised Annex is still supposed to comprise the classical validation types prospective (78%), concurrent (72%) and revalidation (72%) (multiple answers possible). Even retrospective validation is something 46% of the respondents would like to retain in the revised Annex 15.

These answers are a little bit surprising. Although 90% would like to have a process validation life cycle, revalidation is still mentioned by a large part. With a process validation life cycle a routine revalidation is normally not needed, though.

With regard to a Cleaning Validation just 50% (from 257 responding) would like to have a 3-batch-validation, the other nearly 50% would like to define the number of cleaning validation batches regarding risk analysis. This is also somewhat suprising, but follows a modern approach.

These results will also be forwarded to the EMA for information.

Details are also discussed during ECA´s 5th European GMP Conference in Heidelberg, Germany, from 6-7 June. There you will have the opportunity to meet the members of ECA´s  Validation Expert Group . Members of this group also received the survey results in more detail.

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