RE: Cytotoxic Drug Substance Contribution from JD Mallet written on 9/23/2008 at 16:57
Original contribution: Cytotoxic Drug Substance written by KNITI on 9/23/2008 at 06:30) Dear Kniti,
In cGMP (meaning today 21CFR) I don't think you will find clear instruction to have separate facilities as requested for penicillin in 211.42. However you should remember that "c" in "cGMP" means "current" and that FDA has clearly issued his opinion. You can find this in the 1996 proposed rule 211.240
Concerning EU-GMP it is clearly stated that, depending on the nature of the product, you could need separate facilities in items 3.6, 5.18 (Part I) and in items 4.40 & 4.41 (Part II).
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