Risk-Based Approach to Supplier Qualification in GMP Manufacturing

A risk-based approach to supplier qualification in GMP manufacturing ensures that suppliers are evaluated, selected, and monitored based on their potential impact on product quality and patient safety.

Regulatory agencies, including the FDA and EMA, emphasize the need for pharmaceutical, biotechnology, and medical device companies to implement robust supplier qualification programs aligned with GMP principles. By categorizing suppliers based on risk, conducting thorough risk assessments, and applying targeted audits and ongoing monitoring strategies, companies can mitigate compliance risks, ensure supply chain integrity, and enhance product quality. This approach not only meets regulatory expectations but also optimizes resources, focusing efforts on high-risk suppliers while maintaining efficiency in supplier management.

Why you should Attend:
Participants should attend this webinar to gain essential insights into implementing a structured, regulatory-compliant supplier qualification program with a focus on risk management. Learn about global regulatory expectations, practical strategies for assessing supplier risks, and best practices for audits, quality agreements, and ongoing supplier monitoring.

Designed for professionals in quality assurance, regulatory compliance, procurement, and supply chain management, this session provides the tools needed to enhance supplier oversight, reduce compliance risks, and improve product quality. Stay ahead of evolving regulations and streamline the supplier qualification process effectively.

Areas Covered in the Session:

• Introduction
• Welcome & Housekeeping
• Brief introduction of the speaker
• Overview of webinar agenda and objectives
• Importance of supplier qualification in GMP compliance
• Why Supplier Qualification Matters
• Role of suppliers in GMP manufacturing
• Risks associated with non-compliant suppliers
• Regulatory expectations (FDA, EMA, MHRA, etc.)
• Regulatory Expectations and Guidelines
• Global Regulatory Requirements for Supplier Qualification
• FDA’s GMP requirements (21 CFR Part 210/211, Part 820 for devices)
• EMA’s guidelines on GMP for excipients and APIs
• ICH Q10: Pharmaceutical Quality System
• ISO 13485 supplier controls for medical devices
• Understanding Risk-Based Approaches in Regulatory Context
• ICH Q9: Quality Risk Management
• Risk categories in supplier qualification
• Supplier Qualification Process - A Risk-Based Approach
• Risk Categorization of Suppliers
• Critical, major, and minor suppliers
• Identifying high-risk vs. low-risk suppliers
• Supplier Qualification Lifecycle
• Initial qualification
• Ongoing monitoring
• Requalification and risk reassessment
• Steps to Implement a Risk-Based Supplier Qualification Program
• Step 1: Supplier Risk Assessment
• Evaluating supplier’s impact on product quality and patient safety
• Risk assessment tools (FMEA, decision trees)
• Step 2: Supplier Selection and Qualification
• Due diligence and regulatory compliance checks
• Documented evidence of GMP compliance
• Step 3: Supplier Audits and Performance Evaluation
• When to conduct on-site vs. remote audits
• Audit scoring and risk prioritization
• Step 4: Supplier Agreements and Quality Technical Agreements (QTA)
• Key elements to include in a QTA
• Legal and compliance considerations
• Step 5: Ongoing Supplier Monitoring and Periodic Review
• Supplier scorecards and performance metrics
• Handling supplier changes and deviations
• Common Challenges and Best Practices
• Challenges in Supplier Qualification
• Lack of transparency from suppliers
• Inconsistent regulatory expectations across regions
• Managing supplier nonconformances
• Best Practices for Effective Supplier Management
• Leveraging digital tools for supplier qualification
• Developing strong supplier relationships
• Continuous improvement and training
• Cse Study Discussion
• Real-World Example of Risk-Based Supplier Qualification
• Key takeaways and lessons learned
• Interactive discussion on audience experiences

• Quality & Compliance
• Quality Assurance (QA) Professionals
• Quality Control (QC) Specialists
• GMP Compliance Officers
• Regulatory Affairs Specialists
• Supply Chain & Procurement
• Supply Chain Managers
• Procurement Specialists
• Supplier Quality Engineers
• Vendor Management Professionals
• Manufacturing & Operations
• Manufacturing Managers
• Production Supervisors
• Operations Executives
• Auditing & Risk Management
• GMP Auditors
• Supplier Auditors
• Risk Management Professionals
• Research & Development
• R&D Scientists (for API, raw materials, and components)
• Process Development Engineers
• Other Relevant Roles
• Consultants in GMP, regulatory compliance, and supply chain management
• Medical Device and Pharmaceutical Industry Professionals involved in supplier oversight