Raising the Bar in GxP Compliance – Part 18: Navigating Emerging Markets with Robust GxP Oversight
Welcome to the eighteenth 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 the unique compliance challenges and opportunities in emerging markets. As pharmaceutical companies expand globally, maintaining high GxP standards amid diverse regulatory environments becomes critical. Discover how robust supplier qualification, independent third-party GMP audits, and smart digital oversight—like Rephine Intelligence—are empowering organisations to ensure product quality, protect patient safety, and achieve regulatory confidence in even the most complex markets.
Expanding into emerging markets demands more than ambition—it requires unwavering GxP oversight.
Fragmented supply chains, regulatory gaps, and quality risks make robust compliance strategies essential to ensuring safe medicines reach patients everywhere.
Why GxP Compliance Matters in Emerging Markets
Expanding access to safe, effective, and high-quality medicines is a global public health priority. However, emerging markets often face significant challenges in establishing robust pharmaceutical quality systems that fully meet international GxP compliance standards.
At the same time, global companies seeking to operate in these regions must navigate complex regulatory environments while maintaining the same high standards expected in mature markets. This is where rigorous GMP compliance, strong supplier qualification, and effective third-party auditing play a critical role in protecting patients and public health.
Compliance Challenges Unique to Emerging Markets
Emerging markets present specific challenges for quality oversight:
- Varied or evolving national regulatory frameworks
- Inconsistent local GMP infrastructure
- Limited local audit expertise or inspectorate capacity
- Complex and fragmented supplier networks
- Growing prevalence of counterfeit or substandard medicines
Without strong GxP compliance systems, these factors can expose patients to increased safety risks and compromise supply chain integrity.
Aligning with Global GxP Standards
Organisations such as the WHO Prequalification Programme, PIC/S, EMA, FDA, and regional authorities increasingly promote harmonised GxP standards to ensure consistent product quality across borders. Global companies operating in emerging markets are expected to:
- Apply internationally recognised GMP standards
- Implement effective supplier qualification and oversight
- Establish risk-based audit programmes that include local and regional suppliers
- Ensure full data integrity and traceability across complex supply chains
The Role of Independent Third-Party Audits
Independent third-party GMP audits are essential tools to:
- Provide objective verification of compliance for remote or high-risk suppliers
- Build local capacity where regulatory oversight is limited
- Facilitate mutual recognition and regulatory approvals
- Support global MAH and MIAH/QP requirements for qualified supplier networks
- Enhance transparency and global supply chain confidence
Digital Tools for Smarter Oversight
In emerging markets where travel or local capacity may be constrained, digital tools such as:
- Remote audits with secure video platforms
- Centralised audit repositories for shared access
- Real-time supplier monitoring via Rephine Intelligence
- Integrated supplier risk scoring models can significantly strengthen control while reducing operational burdens.
How Rephine Supports GxP Compliance in Emerging Markets
Rephine supports companies operating in emerging markets to establish and maintain strong, compliant, and efficient GxP oversight frameworks, providing:
✅ Global third-party GMP audits, including remote capabilities
✅ Supplier qualification and risk assessment models tailored for emerging regions
✅ Digital audit repository integration
✅ Continuous supplier monitoring with Rephine Intelligence
✅ Consulting on building local quality system capacity and regulatory engagement
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.
