Welcome to the sixth instalment of Raising the Bar in GxP Compliance, Rephine’s expert-led blog series for QA and regulatory professionals.
In this edition, we focus on the evolving landscape of cleaning validation—a critical, yet often underestimated, pillar of GMP compliance. As global health authorities tighten expectations around risk-based validation and toxicological assessments, organisations must elevate their strategies to meet modern standards.
Learn how Rephine empowers pharmaceutical and biotech companies to design scientifically sound, audit-ready cleaning programs that not only ensure patient safety, but also strengthen inspection outcomes and operational efficiency.
Cleaning is no longer just a hygiene measure—it’s a critical control point.
In today’s regulatory climate, cleaning validation must be science-based, risk-driven, and fully defensible. Regulators expect more than just residue limits—they demand lifecycle thinking, toxicological justification, and robust documentation.
Cleaning Validation: A Cornerstone of GMP Compliance
Cleaning validation is a fundamental component of GMP compliance in pharmaceutical and biologics manufacturing. It ensures that equipment used in the production of medicinal products is cleaned to a predefined standard, minimizing cross-contamination risk and ensuring patient safety.
Meeting Global Regulatory Expectations
Regulatory authorities—including the FDA, EMA, and PIC/S—require manufacturers to demonstrate that their cleaning procedures are validated, reproducible, and based on sound scientific rationale. With increased regulatory scrutiny and evolving expectations (e.g., toxicological risk-based limits), cleaning validation programs must be robust, risk-based, and well-documented.
Core Elements of a Compliant Cleaning Validation Program
A compliant cleaning validation strategy must address:
- Worst-case product and equipment selection based on risk
- Acceptance limits based on health-based exposure limits (HBELs) and PDEs
- Swab and rinse sampling techniques with validated analytical methods
- Visual inspection limits and criteria
- Campaign strategies, equipment hold times, and re-cleaning triggers
- Lifecycle management: periodic revalidation and continuous verification
How Rephine Supports Cleaning Validation Excellence
At Rephine, we help pharmaceutical and biotech manufacturers design and optimize cleaning validation programs that are science-based, regulator-ready, and efficient:
✅ GMP Consulting: We evaluate current validation protocols and practices for compliance against current EMA, FDA, and WHO expectations—including Annex 15, Q&A guidelines, and emerging standards for HBELs.
✅ Third-Party GMP Audits: Our audits assess not only documentation but also implementation, sampling locations, analytical methods, and integration with quality risk management.
✅ Supplier Qualification Support: We assess contract manufacturers and cleaning service providers through our audit report library or through custom audits, identifying cleaning risks within your supply chain.
✅ Training and Coaching: We offer targeted training to QA and production staff on lifecycle cleaning validation and practical implementation of risk-based approaches.
Why Partner with Rephine
Rephine provides the technical and regulatory insight to ensure your cleaning validation program is defensible, aligned with global standards, and optimized for both compliance and operational efficiency. With our expertise, you can avoid inspection findings, reduce product risk, and enhance trust in your manufacturing processes.
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.