This document intends to provide expert guidance to the API/intermediate industry and its customers for the implementation and maintenance of appropriate Quality Agreements.
It is obvious that consistent standards for such agreements will provide the following benefits to the industry:
Following this document will provide the current “state of the art” for Quality Agreements in the pharmaceutical (API/intermediate) supply chain.
The APIC Quality Agreement Guideline and the corresponding template are designed to be a flexible model for preparing Quality Agreements wherever such an agreement is desired. It defines the appropriate items that should be addressed in a Quality Agreement. The template is designed to be global in scope and contents, thus being suitable for the use in all regions.
You can access the Quality Agreement Guideline and Template here.
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