December saw the adoption by the European Commission of a new Annex to the EU Guide to GMP. The new Annex - Annex 19 - gives guidance on the keeping and storage of reference and retention samples and comes into force in June of this year.
The scope of the document includes reference samples for starting materials, packaging materials and finished products, and retention samples for finished products.
It also includes guidance on the holding of retention samples for parallel imported/distributed products.
The Annex gives detailed guidance on the handling of these samples and in particular specifies the retention periods for them. For reference and retention samples of finished products it specifies a retention time of at least one year after the expiry date of the product.
For the reference samples of starting materials it specifies a period of two years after the release date of the product and for packaging materials at least the length of the shelf-life of the finished product.
The Annex also gives guidance on the arrangements for the keeping of such samples, and in particular on the requirements of location for samples of products manufactured outside the EU and the European Economic Area.
Other provisions give guidance on the storage conditions for these samples and some specific guidance on parallel imported/distributed products.
The new guidance can be viewed on the Commission's website at: http://pharmacos.eudra.org/F2/eudralex/vol-4/pdfs-en/2005_12_14_annex19.pdf
As with all such new guidance issued by the European authorities, the ABPI will be monitoring its implementation and application.