Raising the Bar in GxP Compliance – Part 3: How to Be Inspection-Ready Every Time
Welcome to the latest edition of Raising the Bar in GxP Compliance, where we explore what it truly takes to prepare for—and succeed in—regulatory inspections. For quality and regulatory professionals, inspection readiness goes far beyond having documents in order. It’s about proving a culture of quality, demonstrating process control, and building systems that can stand up to scrutiny. In this edition, we unpack how Rephine’s tailored approach—combining GMP expertise, mock audits, and supplier qualification strategies—helps organisations prepare confidently for inspections by authorities such as the FDA, EMA, MHRA, and ANVISA.
Preparing for a regulatory inspection is not just about documentation—it’s about proving control, demonstrating a culture of quality, and showing that your systems are inspection-resilient.
With increasing complexity in global regulations and supply chains, pharmaceutical and medical device companies must adopt a proactive, structured approach to GxP inspection readiness.
Expert Support for Regulatory Inspections Across Global Authorities
At Rephine, we specialize in helping organizations achieve successful outcomes in inspections by the FDA, EMA, MHRA, ANVISA, and other authorities. Our approach combines deep GMP expertise with practical experience across a broad range of regulated domains, including biotech, APIs, sterile manufacturing, and medical devices.
We begin with a tailored readiness assessment, covering: – PQS health checks (quality system architecture, CAPA, deviations) – Data integrity and documentation practices – Supply chain robustness and supplier qualification – Validation status of key processes (e.g., cleaning, sterilization, computerized systems) – Annex 1 and risk-based contamination control strategies
Tailored GxP Readiness Assessments That Go Beyond Documentation
We begin with a tailored readiness assessment, covering:
– PQS health checks (quality system architecture, CAPA, deviations)
– Data integrity and documentation practices
– Supply chain robustness and supplier qualification
– Validation status of key processes (e.g., cleaning, sterilization, computerized systems)
– Annex 1 and risk-based contamination control strategies
Mock Audits That Mirror Real Inspection Pressure
Rephine conducts mock audits that simulate real inspection pressure and provide immediate, actionable findings. All our audits are independent and conflict-free, offering clients both credibility and insight. Our team includes former inspectors and senior QA professionals who understand not only the “what” but also the “why” behind regulatory expectations.
Shared-Cost Third-Party Audits to Support Supplier Oversight
For companies managing multiple CMOs or raw material providers, we offer a shared-cost, third-party audit service, where you can access our audit report library or request customized audits tailored to your specific compliance needs. This model improves inspection readiness while optimizing audit budgets—especially valuable when qualifying or requalifying suppliers globally.
In-Depth Audit Reports, Customised by Product and Market
Our reports are structured, in-depth, and customized to your product type and market requirements. Whether your challenge is Annex 1 compliance, data governance, or supplier risk mitigation, Rephine ensures that you’re not just “passing the test” but building sustainable systems that stand up to scrutiny.
Stay Ahead of Regulatory Expectations with Rephine
Preparing for a GxP inspection is about more than ticking boxes—it’s about cultivating a culture of quality and proving ongoing control.
With Rephine by your side, you’ll enter every inspection prepared, confident, and in control—knowing your systems are built to withstand scrutiny today and tomorrow.
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.