Letter from Global Technical Officer on FDA Guidance for Industry – Sterile Drug Products Produced by Aseptic Processing.

Dear BFS member,

On September 5^th, 2003 the Federal Register of the FDA published its notice of the draft guideline on aseptic processing, including the Appendix 2 covering BFS-processing. The Industry now have 60 days to submit any comments on this very important document, with the deadline set to Nov 4^th, 2003.

As most you are aware, the BFS IOA has been very active indeed in discussions with PDA and FDA on the previous concept paper. I am glad to say that many of the comments submitted both orally at PDA conferences during 2002/2003 and in written (Letter to FDA from BFS IOA, March 5^th 2003) were acknowledged and have been used by the FDA in their preparation of the current draft guidance. However, we must not relax at this point but should now carefully consider if further comments are needed on the draft guidance.

I would like to ask all member companies to read the guidance text (read>> draft guideline on aseptic processing) and specifically Appendix 2, and submit any comments you might have to myself or any of the board members or appointed Officer in your region. To meet the deadline for comments to the FDA I need your comments preferably before Oct. 10^th.

If there are any operator companies which still have not completed the BFS Aseptic Industry Survey sent out in June-03, please do so a.s.a.p. and send your results to Prof. Ljungqvist at the Royal Institute of Technology, as stated in the Introduction part of the Survey. Completion of this survey will hopefully help us in our writing of the final comment letter to the FDA.

The final version of the comment letter will be published on the BFS homepage as soon as possible after Nov 4^th. Thank you in advance for your cooperation.

Anders Löfgren, Ph.D.
Global Technical Officer, BFS IOA