The quality of ingredients impacts the quality of finished products. Supplier qualification requirements address this. However, the complex and global nature of the supply chains and the companies supplying the ingredients, combined with resource constraints limits the ability to address risks in ingredients and qualify suppliers. Third-party verification of ingredients that includes review of conformance to up-to-date monographs and GMP-Related General Chapters can help ensure the quality of your raw materials and reduce the risk to finished product quality. As a part of your supplier qualification process, verification can help you mitigate quality risks, and free resources to address other quality risks.
Identify the value of up-to-date excipient monographs.
Understand the value of widely accepted public GMP standards as implemented through USP General Chapters.
Understand the value of a comprehensive program for verifying the quality of an excipient that includes verification of conformance to GMP standards, verification of conformance to an up-to-date USP monograph and verification of the implementation of appropriate controls throughout the process to ensure product quality.