RE: contract manufacturing of API Contribution from JD Mallet written on 9/6/2010 at 07:31
Original contribution: contract manufacturing of API written by MS on 9/6/2010 at 06:21) Dear MS,
First of all I would like to suggest you to refer to the ICH Q7A guide (or Part II of EU-GMP which is the same) on Cpahter 16.
Then read paragraphs 16.10 to 16.16 before to write your procedure.
You may also be inspired by the arrangements set up in Chapter 7 of the Part I of the EU-GMP guide.
Hope this will help you.
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