Process validation demonstrates that production processes consistently yield devices that meet required quality, safety and performance – especially where results cannot be fully verified by subsequent inspection and test.
About this Whitepaper
This whitepaper provides a practical guide to planning and executing manufacturing process validation under the European regulatory framework. It explains how to align EU MDR 2017/745 and IVDR 2017/746 with EN ISO 13485:2016 and EN ISO 14971, ensuring compliance while strengthening quality systems.
You will learn:
- When to validate vs. verify, using EN ISO 13485:2016, FDA 21 CFR 820.75/QMSR, and GHTF/SG3/N99-10 guidance.
- The lifecycle approach: Process Design, Process Performance Qualification (PPQ), and Ongoing Process Verification.
- How to define Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) and establish robust control strategies.
- Validation requirements for sterilization and packaging processes, including ISO 11135, ISO 11137-1, EN ISO 25424, and ISO 11607-2.
- Essential documentation: PPQ protocols, statistical sampling rationales, and validation reports.
- Change control, revalidation triggers, and common audit deficiencies to avoid.
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