Does single API manufactured by same vendor at different sites or units can be used in manufacturing of one finished product batch/lot? if DMF is same?

Production
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Does single API manufactured by same vendor at different sites or units can be used in manufacturing of one finished product batch/lot? if DMF is same?

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Yes, please. You can use such API provided the following conditions are complied,

  • Different sites of API manufacturing (of the same vendor) should be audited and approved by your QA as a part of vendor qualification.

  • The specification of that API should be the same.

  • The route of synthesis of that API manufactured at different sites must be the same (with impurities and their levels).

  • The manufacturing process of the finished product (tablets, capsules, Liquids, etc.) using that API manufactured at different sites should be validated.

  • Your DMF should have listed all sites of manufacturing of that API from the same vendor.

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