Publication Date: 2024/02/10
Abstract: Vendor qualification is a crucial step to ensure the delivery of high-quality and safe medicines, aligning with GMP requirements. The objective of this process is to avert adverse events, recalls, or potential health risks associated with substandard medication. Regulatory authorities oversee and guide vendor qualification processes. This article specifically highlights the personnel engaged in vendor qualification and the rigorous vendor selection process and QUEST approach for selecting and qualifying vendors. This article delves into the significance of vendor assessment, reassessment, and the structured approach required for qualifying vendors.The Supply Chain Management team coordinates with QA to perform vendor qualification. Vendor rating systems are explained, emphasizing disqualification if a batch doesn't meet critical test specifications. In such cases, a re-evaluation and investigation are conducted. Clear communication with the vendor regarding disqualification reasons is imperative. The review article provides an in-depth procedure for qualifying raw material vendors, emphasizing stringent quality standards
Keywords: ICH Guideline, ISO, QUEST Approach, Raw Material, Vendor Qualification, Vendor Rating.
DOI: https://doi.org/10.5281/zenodo.10642941
PDF: https://ijirst.demo4.arinfotech.co/assets/upload/files/IJISRT24JAN1238.pdf
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