Authors :
Isha Dubey; Pawan Patel; Gurmeet S. Chhabra; Nimita Manocha
Volume/Issue :
Volume 9 - 2024, Issue 1 - January
Google Scholar :
http://tinyurl.com/5xezxc3x
Scribd :
http://tinyurl.com/2nh55j59
DOI :
https://doi.org/10.5281/zenodo.10642941
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.
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.
