RE: RE: Acceptance criteria for residue carry over Contribution from JD Mallet written on 9/5/2010 at 22:42
Original contribution: RE: Acceptance criteria for residue carry over written by Ashish jain on 9/5/2010 at 07:05) The exact requirement can be found in the PIC/S guidance PI-006 :
QUOTE
Carry-over of product residues should meet defined criteria, for example THE MOST STRINGENT of the following three riteria:
(a) No more than 0.1% of the normal therapeutic dose of any product will appear in the maximum daily dose of the following product,
(b) No more than 10 ppm of any product will appear in another product,
(c) No quantity of residue should be visible on the equipment after cleaning procedures are performed. Spiking studies should determine the
concentration at which most active ingredients are visible,
UNQUOTE
Answering this Contribution:
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