RE: RE: RE: RE: RE: Cytotoxic Drug Substance Contribution from JD Mallet written on 9/24/2008 at 15:00
Original contribution: RE: RE: RE: RE: Cytotoxic Drug Substance written by KNITI on 9/24/2008 at 09:28) Dear Kniti,
For Steroid API the principles are the same : it depends on the activity, toxicity, sensitivity of the molecule(s). Some GMP (e.g. Schedule M in India)are making a difference between "sex hormons" (dosed in microgrammes) and other "hormons" like anti-inflammatory steroids (dosed in milligrammes). This could be a leading way for you to consider in deciding whether or not you need separated facilities.
Generally speaking I would recommend you to assess the need for separate facilities for any product which therapeutic dose is less than 1 mg or for any sensitive product ... But, again, the best is to read, re-read and re-read again the EU-GMPs, WHO-GMPs or cGMP-Notes.
Answers to this contribution:
Answering this Contribution:
|
