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I am looking for the retention samples to be retained for the
submission for MCC (south africa). What is the min. no.of drug samples
required to be retained as retention samples as per the MCC guidlines.
so please let me know.
thanking you
Maneesh S
Research Assistant
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The following message was posted to: PharmPK
Dear Maneesh,
As per MCC guidelines, a sufficient quantity of test and reference
formulations have to be retained as retention samples. Since the
guidance
does not specify the exact quantity to be retained, to be on a safer
side -
you can retain five times the quantity required for the release tests.
(around 200-250 units )
Regards
Ganesh
M.M. Ganesh
Ranbaxy Clinical Pharmacology Unit
Majeedia Hospital
Tel: 011-29959588
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