Raising the Bar in GxP Compliance: A New Series for QA and Regulatory Professionals
Welcome to the first edition of Raising the Bar in GxP Compliance—a new Rephine series designed for quality assurance and regulatory professionals navigating the complexities of GxP requirements. Each article will examine key regulatory developments and offer expert-led insights to support robust compliance strategies. We begin with an in-depth look at the EMA’s updated guidance on third-party GMP audits, focusing on conflict of interest management and the assurance of impartial, high-quality audit reporting.
The European Medicines Agency (EMA) has recently revised its Guidance on good manufacturing practice and good distribution practice: Questions and answers to clarify expectations surrounding the use of third-party GMP audits in qualifying active substance suppliers. The update places renewed emphasis on independence, impartiality, and the effective management of conflicts of interest, particularly where external auditors are used instead of direct audits by the Manufacturing Authorisation (MIA) holder.
At Rephine, we welcome this updated guidance. As a long-established provider of independent GMP audit services, Rephine has always prioritised impartiality and transparency. In response to the EMA’s clarifications, we are refining and reinforcing our existing practices to ensure continued compliance and to enhance assurance for both clients and auditee sites.
Key Changes in EMA Guidance
The revised EMA guidance reinforces the importance of:
- Conflict of interest assessment: Conflicts must be declared, evaluated, and addressed. Examples include:
- Auditors with financial, familial, or professional ties to the auditee.
- Situations where a commercial interest exists in selling or distributing the audit report.
- Attempts to define the GMP scope in a way that avoids compliance obligations.
- Qualified Person (QP) responsibility: QPs must consider conflict of interest declarations as part of their review of third-party audit reports before making supplier qualification decisions.
These updates aim to strengthen the credibility of third-party GMP audits across the supply chain and ensure that both clients and auditee sites can trust the objectivity of the audit process.
Rephine’s Response: Refining Established Independent GMP Audit Practices
Rephine is reaffirming and enhancing its current systems to reflect the updated EMA guidance and provide increased assurance to all stakeholders involved in the audit process.
Enhanced Conflict of Interest Framework
Rephine has advanced its established impartiality assessment process to ensure that potential conflicts of interest are identified and effectively mitigated. This includes:
- Disclosure and assessment of any personal or professional relationships between auditors and auditees, with reallocation of auditors where necessary.
- Maintenance of independence when audits are shared across multiple clients or involve sensitive commercial dynamics.
- Clear separation between commercial interests and audit execution, ensuring objectivity in all audit outputs.
Auditors continue to sign conflict of interest declarations, reinforcing client confidence and strengthening trust with auditee sites.
Revised Technical Agreement Language
Rephine’s Technical Agreements with clients have been updated to provide contractual clarity and assurance, explicitly confirming that:
- Rephine and its auditors have no financial or commercial relationship with the auditee.
- Conflict of interest assessments are conducted for each audit.
- Independence and impartiality are maintained throughout the audit lifecycle.
These commitments benefit both clients and auditees by ensuring transparent expectations and a consistent audit framework.
Strengthened Quality and Governance Systems
Rephine’s ISO 17020-aligned quality system has been further enhanced to:
- Reinforce the separation between technical teams and commercial functions.
- Systematically conduct and document company-level audit impartiality assessments.
- Ensure that audit practices not only meet regulatory expectations but also reflect industry best practices in transparency, professionalism, and accountability.
These refinements demonstrate Rephine’s long-standing commitment to pharma compliance, regulatory alignment, and robust supplier qualification.
A Welcome Step Toward Industry Integrity
Rephine welcomes the EMA’s updated guidance as a positive and necessary development for the industry. Inconsistencies in how conflicts of interest are handled may undermine trust in third-party GMP audits. Rephine supports this renewed emphasis on impartiality as a way to uphold the integrity of independent GMP audits and protect public health.
These enhancements also benefit auditee sites, who deserve fairness and clarity in how audits are conducted, as well as clients, who rely on objective audit findings for critical supply chain decisions.
A Trusted Partner for Third-Party GMP Audits
By fully aligning with EMA expectations and proactively managing any potential conflict of interest, Rephine provides high-quality audit reports that support seamless regulatory approval and supplier qualification. Our clients rely on our independent GMP audits to strengthen compliance, optimise supply chain control, and achieve confident, conflict-free regulatory outcomes.
With over 4,500 audits delivered worldwide, Rephine is recognised for its commitment to integrity, transparency, and GxP excellence. Choosing Rephine means choosing a trusted partner that understands the regulatory landscape, operates with independence, and delivers GMP audit services tailored to the evolving needs of the pharmaceutical industry—while maintaining trust with both clients and auditee partners.
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.