Is any guideline available for reduce microbial testing in Pharmaceutical preparation.

Parveen    |    03-07-2017

1 Answers:

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Shivam    |    26-07-2017

If the approved market authorization dossier does not explicitly allow for skip testing, we're not entitled to do that. A guideline can never overrule a MAA! Violation of MAAs would involve immediate market recall of respective batches and withdrawal of import licence! Damage claims may follow.



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