Prequalification of Active Pharmaceutical Ingredients - Confirmation of API Prequalification Document

Confirmation of Active Pharmaceutical Ingredients (APIs) Prequalification Document

Each successful API-PQ applicant will be provided with a Confirmation of Active Pharmaceutical Ingredient (API) Prequalification document.

The Confirmation of Active Pharmaceutical Ingredient (API) Prequalification document contains copies of the accepted retest period and storage conditions, accepted API specifications, assay test methodology and related substances test methodology.  This information complements the API details published in the List of Prequalified APIs.

This document may be provided at the discretion of the API manufacturer to other parties, such as FPP manufacturers.  The FPP manufacturer may then use this documentation as evidence of the good quality of the API being used in their product.

Third parties receiving copies of a Confirmation of Active Pharmaceutical Ingredient (API) Prequalification Document can confirm the validity of this document in two ways.

First, the confirmation document includes an authorization box.  This box should be filled out by the API manufacturer in the name of the manufacturer or agent seeking to use the document.

Second, the validity of the Confirmation of Active Pharmaceutical Ingredient (API) Prequalification document can determined by comparing the date of the document with that published on the List of prequalified APIs.

A revised Confirmation of Active Pharmaceutical Ingredient (API) Prequalification document will be issued every time there is a change in the API specifications, retest or storage condition, assay or related substance test method.

Related Link:

• List of Prequalified APIs