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Forums Production and Manufacturing APIs & Intermediates Pesticide and Pesticide intermediate in Pharma blocks Reply To: Pesticide and Pesticide intermediate in Pharma blocks

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    Going by the ICH Q7A GMP guide for APIs, Schedule M GMP requirements (Drugs & Cosmetics Act, India) Pesticide products cannot be manufactured in Pharma Manufacturing areas.
    As for pesticide intermediates, unless the intermediate is a very generic early stage intermediate which may be a building block for Pesticide molecule as well as a Pharma active ingredient molecule, manufacture of an intermediate for Pesticide is not recommended in a Pharma manufacturing facility. (Also refer the attached explanatory document)

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