ABPI news: February 2006

In May 2003 the European Medicines Agency (EMEA), on behalf of the European Commission, issued proposals for a revision of Annex 1 to the EC GMP Guide. This Annex sets out guidance on the manufacture of sterile medicinal products.

The initial proposals were the subject of a significant amount of comment from various parties - particularly in relation to the provision of recommendations on standards of environmental cleanliness for cleanrooms. This particular point was widely debated at the time and subsequently.

In light of the comments received and the subsequent debate, towards the end of last year the European Commission issued a revised proposal for updating Annex 1.

The latest revision includes a number of explanations and clarifications which were sought as a result of the previous round of consultation.

These include:

• interpretation of existing limits for 5µm particle counts in Grade A and Grade B zones to allow for false counts;

• additional references to the International Standard for the classification of clean areas EN/ISO 146644-1;

• explanation of the significance of 5µm particle counts in Grade A and Grade B zones;

• harmonisation of the limits for aseptic process simulation tests with those used by the FDA.

The willingness of the Commission to re-consult on a second draft is welcomed, and the industry is considering fully the new proposals. For those who wish to comment on the proposals they have until the end of April and they can do so either direct to the Commission or via their trade association.

In this respect the ABPI has sought the views of its members and will be feeding back comment appropriately. The outcome of the consultation will reviewed here in due course.