Prequalification of APIs - Indian Pharmaceutical Association

Confirmation of API PQ document (CPQ)
It is intended that the CPQ is circulated to relevant parties, such as
FPP manufacturers.
Wider recognition of API-PQ is a long term goal.
Manufacturers of a PQ’d API currently participating in the APIMF
procedure should circulate the CPQ to associated FPP
manufacturer’s.
Normally the FPP manufacturer will then submit the CPQ and
withdraw from the APIMF procedure.
FPP manufacturers need to actively request this change.
This will have post-Prequalification benefits in terms of the number of
variations they will need to file.
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Prequalification of APIs
Mumbai September 2012