From: Friedman, Rick L
Sent: Tuesday, October 14, 2003 10:05 AM
To: 'Didier Meyer'
Cc: Dockets, FDA
Subject: RE: Draft Guidance for Industry Sterile Drugs Products produced
by aseptic processing- CGMP

Dear Didier, 

Good to hear from you!  Hope all is well in France...  

In order for it to be considered in review of the aseptic guidance, please send your below recommendation to the following email address:   

fdadockets@oc.fda.gov 

You should reference Docket #2003D-0382 in your email and note the relevant line number/s/ (use the line numbers in the pdf. version of the document) to help FDA process them efficiently.  

(There is also a second option for submitting comments: visit http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm 
and search under docket 2003D-0382 in order to do a web-based electronic submission.)

Best Regards,
Rick


-----Original Message-----
From: Didier Meyer [mailto:DMeyer@lacalhene.fr]
Sent: Monday, October 13, 2003 1:13 PM
To: friedmanr@cder.fda.gov
Subject: Draft Guidance for Industry Sterile Drugs Products produced by
aseptic processing- CGMP


Dear Mr Friedman,
In  IX.  STERILITY TESTING, I would like to clarify the Lines 1346-1347
in : "The testing laboratory environment should employ a
microbiologically controlled environment equal or better than the
filling and closing operation,examples of such environments include
flexible or rigid design closed isolators having either turbulent or
unidirectional airflow" 
Best regards,
Didier Meyer

Didier Meyer
Marketing Manager
La Calhene
1 rue du Comté Donegal
41102  VENDOME FRANCE
Tel +33 0 254734692
Fax +33 0 254734748
Web www.lacalhene.fr