Validations: Ongoing Review & Risk Scoring
Approved Vendor List (AVL) Governance Approved Vendor List (AVL) Governance Understanding the Importance of an Approved Vendor List (AVL) In the pharmaceutical industry, the selection and ongoing management of suppliers, Contract Manufacturing Organizations (CMOs), and Contract Development and Manufacturing Organizations (CDMOs) are critical components of ensuring product quality and regulatory compliance. An Approved Vendor List (AVL) serves as a foundation…
Supplier Lifecycle: Onboarding to Exit Supplier Lifecycle: Onboarding to Exit Introduction to Supplier Lifecycle Management In the pharmaceutical industry, managing the supplier lifecycle encompasses various critical processes, from onboarding suppliers to eventually exiting their services. This guide aims to provide a comprehensive understanding of the steps involved in the supplier lifecycle, particularly focusing on supplier qualification, quality agreement clauses, vendor…
Risk Scoring Model: Criteria, Weights, and Bands Risk Scoring Model: Criteria, Weights, and Bands The pharmaceutical industry operates in a highly regulated environment where the integrity, safety, and efficacy of products are paramount. Consequently, risk management is critical, particularly regarding supplier qualification, validation deliverables, and the oversight of Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs). This…
Quarterly Business Reviews (QBR): Agendas and KPIs Introduction to Quarterly Business Reviews in Pharma Quarterly Business Reviews (QBR) have emerged as a crucial component in the oversight of suppliers, Contract Manufacturing Organizations (CMOs), and Contract Development and Manufacturing Organizations (CDMOs). In the pharmaceutical industry, where compliance with regulatory standards set forth by the US FDA, EMA, MHRA, and PIC/S is…
Quality Agreements in Review: Refresh Triggers Quality Agreements in Review: Refresh Triggers In the highly regulated pharmaceutical industry, managing supplier and contract manufacturing organization (CMO/CDMO) relationships is critical. An effective quality agreement is a cornerstone of supplier qualification and oversight. This article outlines the necessary steps and refresh triggers that professionals in pharmaceutical quality assurance (QA), clinical operations, regulatory affairs,…
Change Log Surveillance: Signals and Escalations Change Log Surveillance: Signals and Escalations Introduction to Change Log Surveillance Change Log Surveillance is an essential aspect of maintaining compliance and quality in the pharmaceutical industry, especially when engaging suppliers, Contract Manufacturing Organizations (CMOs), and Contract Development and Manufacturing Organizations (CDMOs). The relentless pursuit of quality consists of identifying and managing risks associated…
Complaint/Deviation Feed into Risk Scores Complaint/Deviation Feed into Risk Scores Introduction to Risk Scoring in Pharmaceutical Oversight In the pharmaceutical industry, effective oversight of suppliers, Contract Manufacturing Organizations (CMOs), Contract Development and Manufacturing Organizations (CDMOs), and technology providers is critical for maintaining product quality and compliance with regulations, such as 21 CFR Part 11. A fundamental aspect of this oversight…