Performing a cleaning validation during the initial phase of a device’s lifecycle aids manufacturers in complying with current good manufacturing practices (CGMP) and quality system (QS) regulation as set forth by FDA for medical device manufacturers. The data gathered during cleaning validations helps manufacturers have confidence in the quality of their finished medical devices during on-site audits performed by both customers and regulators. Find out more on:
- The importance of a cleaning validation
- Considerations for the initial validation
- Residual sources of contamination
- Analytical test methods
The whitepaper was written by Erin Bakes and Alexa Tatarian.
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