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Designing Vendor Oversight for GxP Rigor: From Qualification to Continuous Performance Control

Author(s) Pawankumar Suresh
Country India
Abstract The GxP rigor vendor management is an integral element in providing quality, compliance, and business performance for regulated industries such as pharmaceuticals, biotech, and medical devices. This article introduces a systematic model from qualification to ongoing monitoring of performance to provide vendor accountability and product integrity. With the integration of risk-based method, performance criteria, and regulatory expectations, companies can enjoy the best out of multi-sourcing agreements and minimize service-level risks. Apart from this, continuous monitoring arrangements like audit, computerized monitoring system, and knowledge management processes, allow proactive detection of compliance gaps and facilitate sustainable partnerships. The suggested model focuses on achieving a balance between regulatory intensity and cost-effectiveness to ensure that organizations remain compliant without increasing operational costs. This research emphasizes the position of successful vendor management in harmonizing supply chain resilience, regulatory compliance, and cost optimization, finally resulting in patient protection and product quality during the GxP lifecycle.
Keywords Vendor management, GxP compliance, qualification, ongoing monitoring of performance, regulatory constraints, multi-sourcing, risk management, cost minimization, pharmaceutical quality systems, supply chain robustness.
Field Medical / Pharmacy
Published In Volume 3, Issue 2, February 2022
Published On 2022-02-04
DOI https://doi.org/10.5281/zenodo.17170906
Short DOI https://doi.org/g939g6
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