A Systematic Approach to Process Validation

Process Validation has become a recent buzzword for all sectors of the medical device industry. The route to ensuring that a process is fully validated is not always a clear one, which can all too often result in an inadequately validated process.

This whitepaper will guide companies through the key milestones required to successfully validate a process to meet both European and US requirements. It examines important considerations during process validation including:

• The Installation Qualification (IQ) requirement to provide documented evidence that all equipment used meets installation requirements
• The Operational Qualification (OQ) requirements including the sampling plan and process capability
• The Performance Qualification (PQ) to demonstrate documented evidence of the occurrence under actual manufacturing conditions