Supplier & Third-Party Management in GMP: Qualification, Oversight & Auditing
In today’s global supply chain, Good Manufacturing Practice (GMP) doesn’t end at your site gate. From contract manufacturers and analytical labs to raw material suppliers and outsourced logistics providers, pharmaceutical businesses must ensure that every third-party meets the same compliance standards they would apply internally. This focused 3.5-hour instructor-led course trains QA professionals, QPs, and operations teams to manage outsourced GMP activities in line with Annex 16, ICH Q10/Q11, and MHRA expectations.
Course Details
Instructor
Paul Palmer
Level
Beginner
Duration
3.5 Hours
Type
Instructor led
Course Content
Why is this course essential?
MHRA frequently cites weak supplier oversight as a major finding in GMP inspections. Issues often arise when QPs are not involved in third-party approval, when Quality Agreements are vague or unsigned, or when audit trails for supplier performance are missing. This course helps you build a compliant, risk-based, and proactive supplier management system that inspectors can trust.
What does the course cover?
- Supplier classification based on GMP criticality and risk
- Step-by-step supplier qualification and approval workflows
- Writing and maintaining robust Quality Agreements
- Managing third-party change control, deviations, and CAPAs
- Designing supplier scorecards and monitoring dashboards
- Conducting and documenting third-party audits
- Removing suppliers safely and updating regulatory files
- Preparing audit-ready supplier files and inspection responses
Ideal for?
- Sites with contract manufacturing, testing, or packaging partners
- Importers and distributors managing EU/UK QP oversight
- Clinical trial sponsors using CDMOs or storage depots
- ATMP and IMP manufacturers with decentralised operations
Benefits:
- Aligns supplier control with your QMS, CCS, and audit strategy
- Supports QP declarations and licence renewals
- Prevents inspection findings related to third-party non-compliance
- Encourages QA–Procurement collaboration without compromising control
- Provides real tools: audit checklists, scorecards, agreement templates
What's Included
3.5Hrs of instructor led learning
Usable documents and templates
Real work examples and exercises
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