Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

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

Up
0
Down
::

    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)

    Attachments:
    You must be logged in to view attached files.