如何用TOC进行清洁验证.ppt

Jon Yourkin/ TOC For Cleaning Validation Cleaning Validation – Who is Involved? Steps of the Validation Process Instrument Qualification Determine Residue to be Detected Analytical Method Development Analytical Method Validation Analytical Method Verification Determine Residue to be Cleaned Process Development Process Validation Process Verification Understanding the Terms:Qualification – Analytical Instruments and Process Equipment is “qualified” (IQ/OQ/PQ) to ensure they are installed, operating, and performing properly.Validation -Processes are validated to ensure they are working properly, and that they are robust and repeatable.Verification – Processes are periodically verified, following validation, to ensure the process is still in a validated state. Instrument Qualification - Includes the following: -Installation Qualification (“IQ”) -Operational Qualification (“OQ”) -Performance Qualification (“PQ”) Installation Qualification (“IQ”)- Purpose: To demonstrate that the instrument is installed correctly. IQ Document can be obtained from GE. IQ includes the following: -Installation Protocol and Checklist -Firmware Installation Verification Protocol and Checklist -If Using DataGuard – DataGuard Operation Verification for Firmware Protocol and Checklist Operational Qualification (“OQ”)- Purpose: To demonstrate that the instrument is operating correctly. OQ Document can be obtained from GE. OQ includes the following: -Sample Flow Rate Calibration -Single Point or Multi-point Calibration and Verification -System Suitability -Autoreagent Calibration (Only required if the Autoreagent function is to be used.) Performance Qualification (“PQ”)- Purpose: To demonstrate that the instrument is performing correctly. PQ Document can be obtained from GE. PQ includes the following: -Accuracy and Precision Protocol and Worksheet -Linearity Protocol and Worksheet -Limit of Detection -Limit of Quantitation Understanding Cleaning Validation 1993 -