New Annex 19 "Reference and Retention Samples" Effective June 2006

GMP News No. 680

GMP News
1 March 2006
New Annex 19 "Reference and Retention Samples" Effective June 2006
The European Commission noted in December 2005 that the EU GMP Guide Annex 19 announced earlier (see our GMP News of 21 July 2004) will now become effective on 01 June 2006.

The goal of the new Annex 19 – titled "Reference and Retention Samples" – is to define requirements for storing reference samples for starting materials and packaging materials as well as for finished products.

The Annex 19 differentiates between reference and retention samples:

Reference Samples are samples from starting materials, and packaging materials as well as from finished products, stored for analytical purposes if necessary during their shelf life.

Retention Samples, though, are completely packaged samples of a batch of a finished medicinal product.

What is interesting is the fact that the regulations are also valid for packaging materials:

"Each packaging site should keep reference samples of each batch of primary and printed packaging materials. Availability of printed materials as part of the reference and/or retention sample of the finished product can be accepted."

A new requirement is that a sufficient size of samples to conduct at least two full analyses has to be maintained.

You will find the complete Annex 19 text here:

The impact of the new Annex 19 for reference packaging samples will be discussed at the ECA Education Course "Quality Testing of Pharmaceutical Packaging Materials", from 15-16 March 2006 in Prague.

Please don't miss the opportunity to get more information on the current European (EMEA) and American (FDA) regulatory requirements for packaging materials in Prague.

Dr Günter Brendelberger
on behalf of ECA

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