APIC Quality Agreement Guideline & Template
(version 3, January 2024)
Purpose
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:
- Lower workload (by reduced drafting time)
- Faster implementation (by reduced review times)
- Less complexity (by reduced diversity)
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.
Updates
- Guideline:
a. chapter 3.2 Scope
b. chapter 8. Glossary
c. chapter 10. History / Change Log - Template:
a. chapter II. General Provisions: section II.2 and secction II.7
b. chapter III. Quality Responsibilities:
New passages 9.02, 12.06, 13.02, 22.08 and parts of passage 6.
Updates of passages 1.03, 2.01, 4.01, 5.01, 12.07 and 19.04. Passage 11.04 adapted and listed now in passage 11.01.
Download
You can access the Quality Agreement Guideline and Template here.