RE: RE: Sterile API = medicinal product Contribution from JD Mallet written on 9/3/2010 at 11:43
Original contribution: RE: Sterile API = medicinal product written by ok on 9/3/2010 at 05:39) Dears,
For sure, manufacturing of sterile API should follow the same rules as the ones applicable to the finished products. Please simply read the scope of Q7A version transposedin the EU-GMP guide :
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1.2 Scope
These guidelines apply to the manufacture of active substances for medicinal products for both human and veterinary use. They apply to the manufacture of sterile active substances only up to the point immediately prior to the active ubstance being rendered sterile. The sterilisation and aseptic processing of sterile active substances are not covered, but should be performed in accordance with the principles and guidelines of GMP as laid down in irective 2003/94/EC and interpreted in the GMP Guide including its Annex 1.
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