GMP News No. 641
1 December 2005
EU GMP Guide: New Draft for Annex 1 "Sterile Manufacturing" Published
On 11 November, the EU Commission published a revised draft of Annex 1 to the EU-GMP Guide. This annex formulates the additional requirements on the manufacture of sterile medicinal products. Since the latest major revision was conducted in 1996, the document has been revised several times. However, some of the new versions have given rise to misunderstandings.
Annex 1 was under revision since 2003, especially because EN/ISO 14644-1 on cleanroom technology was meant to be included. Now the EMEA has published a draft (Draft Amendment to Annex 1 of the GMP guide for public consultation) for commenting that - apart from the integration of EN/ISO requirements - takes account of further current developments, one of which is the new FDA Guidance for Industry "Sterile Drug Products Produced by Aseptic Processing".
The changes concern the following topics:
The suggested changes also result in a change in the numbering of the chapters!
Former chapters 3-6 newly structured as chapters 3-11: After the latest revision, the chapters 3-6, especially the notes on cleanroom classification, were among the most discussed chapters of this annex. Since the text had in part been contradictory or unclear, great parts have now been rephrased.
In one of the next GMP News on this website, we will have a close look at the consequences for the industry.
It is evident that the text is strongly oriented towards EN/ISO 14644-1 and that the classification should be considered as independent of the environmental monitoring of the process. Another salient point is that many of the passages on cleanroom measurements that were criticised in the last revision have now been taken up.
Indication of Media Fill Acceptance Criteria
Former chapter 42 - now chapter 47: The text of this chapter is nearly unchanged. The following items have been added:
Bioburden Monitoring Prior to Sterilisation
Former chapter 52 - now chapter 57: The following items have been added:
Former chapter 88 - now chapter 93: The following items have been added:
On the whole, the draft certainly represents a considerable improvement
compared to the last version, above all since it takes account of current
regulations, like EN ISO 14644 and the FDA Aseptic Guide, also with regard
to international harmonisation.
|Our seminar recommendation: On 18 and 19 May 2006, the European Compliance Academy organises the event "Environmental Monitoring - Compliant and Reasonable" in Copenhagen.|