Raising the Bar in GxP Compliance – Part 14: Smarter Supplier Oversight through Risk-Based Auditing
Welcome to the fourteenth instalment of Raising the Bar in GxP Compliance, Rephine’s expert-led blog series for QA and regulatory professionals.
In this edition, we delve into how risk-based auditing enables smarter, more strategic supplier oversight in today’s complex pharmaceutical landscape. As global expectations for supply chain transparency and GxP compliance continue to rise, a blanket approach to auditing is no longer sustainable. Learn how Rephine helps companies design risk-proportionate audit programmes that prioritise resources, reduce costs, and strengthen quality systems—turning regulatory expectations into a competitive edge.
In a resource-constrained world, supplier oversight must be smarter, not just stricter.
Risk-based auditing empowers QA teams to focus efforts where they matter most—on the suppliers and processes that pose the greatest risk to product quality, patient safety, and compliance.
What Is Risk-Based Auditing?
In today’s complex pharmaceutical supply chain, organisations face increasing pressure to ensure full GxP compliance across a vast and growing network of suppliers, CMOs, CROs, and partners. However, auditing every supplier with equal depth and frequency is neither efficient nor sustainable. This is where risk-based auditing becomes a powerful tool.
The Principle Behind Risk-Based Auditing
Risk-based auditing applies the principle of prioritising audit efforts based on the potential risk each supplier or activity represents to product quality, patient safety, and regulatory compliance. Rather than applying a “one-size-fits-all” approach, companies can focus resources on the areas that matter most.
Key Risk Factors to Consider
Key risk factors may include:
- Criticality of the supplied product or service
- Complexity of manufacturing processes
- Regulatory history and inspection outcomes
- Supplier change history and CAPA records
- Results of previous audits, including outstanding or recurrent findings
- Geographic and geopolitical considerations
Regulatory Expectations and Support
Regulators worldwide, including the FDA, EMA, MHRA, and WHO, actively promote risk management principles within pharmaceutical quality systems. The ICH Q9 guideline on Quality Risk Management provides the conceptual framework supporting these strategies.
What Regulators Expect from Risk-Based Audits
A properly designed risk-based audit programme demonstrates to regulators:
- Control over the supplier qualification process
- Rational allocation of audit resources
- Proactive identification of potential compliance gaps
- Commitment to continuous improvement
Beyond Compliance: Business Benefits of Risk-Based Auditing
Regulators worldwide, including the FDA, EMA, MHRA, and WHO, actively promote risk management principles within pharmaceutical quality systems. The ICH Q9 guideline on Quality Risk Management provides the conceptual framework supporting these strategies.
Strategic Advantages Include:
- A robust supplier risk classification system
- Regular review and update of supplier risk profiles
- Full integration of previous audit outcomes and CAPA follow-up status
- Integration of audit findings into supplier scorecards
- Alignment with corporate risk management frameworks
- Use of digital platforms for centralised data management
How Rephine Supports Risk-Based Auditing
Rephine Services Include:
✅ Development of custom risk models and supplier rating systems
✅ Global execution of prioritised third-party GMP audits
✅ Full consideration of audit history and CAPA status for targeted follow-up audits
✅ Integration with digital audit repositories
✅ Ongoing monitoring of supplier performance data
Dr. Eduard Cayón
CSO (Chief Scientific Officer)
About the Author:
Dr. Eduard Cayón is the Chief Scientific Officer (CSO) at Rephine, a global leader in GxP compliance and quality assurance.
We don’t just deliver audits or consultancy services — we partner with clients at every stage of their quality journey, offering end-to-end solutions that empower confidence and compliance.
With over 25 years of experience, Rephine has built an enviable reputation as the gold standard in the industry operating from four primary locations: Stevenage in the UK, Barcelona in Spain, India, and Shanghai in China.
Dr. Cayón, who holds a Ph.D. in Organic Chemistry, is a deeply experienced pharmaceutical industry consultant and auditor.
He is dedicated to supporting pharmaceutical, biotech, and medical device companies in meeting the highest standards of manufacturing and supply chain integrity.