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[June 2024] Implementing ICH Q2(R2) Validation of Analytical Procedures, Dissecting FDA’s Long-Awaited Device Remanufacturing Guidance + Warning Letter Breakdown

We take a deep dive into ICH's guidance on analytical procedure validation, dissect FDA's remanufacturing final guidance, and draw a few important lessons from a recent warning letter.

Welcome to Insider issue #26.

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In our pharma feature, we dive into ICH Q2(R2) Validation of Analytical Procedures — the essential guidelines for developing and validating analytical procedures, ensuring they are fit for purpose throughout their lifecycle. We cover the updated terminology, the integration of development data in validation, and enhanced approaches to robustness and risk management. Additionally, we offer detailed, step-by-step instructions for establishing the Analytical Target Profile (ATP), conducting thorough risk assessments, selecting and calibrating analytical methods, and performing validation studies.

Our device/medtech feature highlights the FDA’s final guidance on remanufacturing medical devices. Released in May, this guidance clarifies the distinctions between servicing and remanufacturing, setting clear regulatory expectations for manufacturers. We provide a detailed breakdown of the guidance, including key regulatory definitions, quality system requirements, labeling and reporting mandates, and practical steps for compliance. Specific recommendations are given on developing internal definitions, establishing robust quality systems, implementing detailed documentation procedures, and engaging proactively with regulatory bodies.

Lastly, our warning letter breakdown examines a recent FDA warning to a pharma firm regarding significant violations at its manufacturing facility. The FDA identified critical issues related to inadequate cleaning procedures, poor root cause analysis, and deficiencies in the quality control unit. We analyze the specific violations cited by the FDA and draw a few specific lessons for quality teams regarding improving cleaning protocols, enhancing investigation processes, and strengthening quality management systems to prevent similar compliance failures.

A big thanks to this month’s expert contributors, Nancy Angus Edge and Michel Moravia.

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