GXP

Implementing an Effective Provider Qualification Program at the Contract Laboratory | IVT

Abstract 

This paper is intended to provide useful hands-on guidance regarding the process of provider qualification. What we have learned of this comes mostly from being employed in smaller contract research organizations (CROs) that have been focused on providing good manufacturing practices (GMP) and good laboratory practices (GLP) support to major pharmaceutical and medical device manufacturers in the form of specialized contract analytical testing services. While this niche is small in comparison to manufacturing, it is clearly within the purview of the US Food and Drug Administration that monitors and holds it to standards in common with manufacturing. The objective for the lab is to design and implement a program that meets all applicable regulatory requirements, not demand too many company resources and correctly place the providers. The approach taken is risk-based. The program design must integrate well with the laboratory’s other quality systems. We cannot claim to be the originators of these ideas; rather, this paper takes from many suggestions made by many quality assurance (QA) auditors over many years having the task of qualifying our laboratory.

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