Raising the Bar in GxP Compliance – Part 17: Sustainable Auditing – Aligning Quality Oversight with ESG Goals
Welcome to the seventeenth instalment of Raising the Bar in GxP Compliance, Rephine’s expert-led blog series for QA and regulatory professionals. In this edition, we explore how sustainable auditing is redefining the future of quality oversight.
With increasing pressure to meet corporate ESG targets, life sciences organisations must reconsider traditional, travel-heavy audit models. Discover how forward-thinking companies—and regulators—are embracing digital, risk-based, and collaborative audit approaches that reduce carbon emissions without compromising GMP compliance. Learn how Rephine supports sustainable transformation through remote audits, shared audit programmes, and real-time supplier intelligence.
Sustainability is no longer optional in pharmaceutical operations.
As environmental accountability rises, quality auditing must evolve—shifting from carbon-intensive routines to smarter, greener practices that still uphold the highest GxP standards.Â
Why Traditional GxP Auditing Needs a Sustainability Overhaul
As the pharmaceutical industry commits to global sustainability targets, the environmental footprint of GxP auditing and quality oversight has come under growing scrutiny. Traditional audit programmes — with extensive global travel, paper-based documentation, and duplicated efforts — often conflict with corporate Environmental, Social, and Governance (ESG) goals.
Adopting sustainable auditing practices allows life sciences organisations to balance strong GMP compliance with responsible environmental stewardship.
The Carbon Footprint of Conventional Audits
Every year, thousands of third-party GMP audits, internal audits, and regulatory inspections require:
- Long-haul air travel to supplier sites
- Hotel stays and ground transport
- Printing and shipping of large audit files
These activities contribute significantly to corporate carbon emissions and resource consumption.
Sustainable Auditing Strategies for Life Sciences
Forward-looking organisations are rethinking their audit models to align with both compliance and sustainability:
Key Tactics for Greener Compliance
- Risk-based audit scheduling to reduce unnecessary site visits while focusing on higher-risk suppliers.
- Increased use of remote and hybrid audits where feasible, leveraging secure digital platforms.
- Adoption of Rephine Intelligence to track supplier trends, performance data, and risk alerts remotely, reducing the need for reactive travel.
- Cloud-based digital audit repositories eliminating paper documentation.
- Enhanced collaboration with trusted third-party audit providers to share audit results and reduce duplication.
- Coordinated audit consortia and data-sharing networks for multi-client audit efficiency.
How Regulators Are Supporting Greener Audit Models
Regulators such as the EMA, FDA, and MHRA have increasingly accepted well-planned remote audits and shared audit programmes as valid elements of supplier oversight, provided data integrity, audit rigor, and confidentiality are preserved.
Benefits of Modern Audit Approaches
Agencies acknowledge that modern audit models can:
- Maintain oversight integrity
- Reduce travel-related risks
- Support global supply chain continuity
- Align with corporate sustainability commitments
How Rephine Enables Sustainable GxP Auditing
Rephine offers fully compliant, sustainable audit solutions designed for both quality and ESG impact:
✅ Global execution of third-party GMP audits, including hybrid models
✅ Access to Rephine’s validated audit repository for shared audit use
✅ Remote auditing capabilities aligned with regulatory guidance
✅ Supplier monitoring through Rephine Intelligence for proactive risk visibility
✅ Consulting on sustainable auditing strategies and ESG alignment
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.
