清洁验证及其风险管理.pptVIP

谢 谢 Another method of setting acceptance criteria is: No more than 10ppm of any product will appear in any other product Further details and worked examples can be found in the appendices of GQG6202 Change ControlAny proposed change to a validated cleaning procedure must be formally assessed for impact on the validated state of the cleaning procedure prior to its implementation Routine MonitoringThe purpose of Cleaning Validation Monitoring is to demonstrate that the procedure is still capable of delivering the cleaning standards that were qualified under the cleaning validation