R
RLKESTER
Recently been involved in conversations regarding the need for calibration of processing equipment - specifically injection molding of medical products.
The careful reading of 21 CFR 820 Sec. 820.70 Production and process controls. Specifically Sec. 820.72 "Inspection, measuring, and test equipment" sub section (b) is where calibration is listed.
Specific reading of the section could indicate only items used for acceptance activities require calibration. The extension of the concept to processing equipment therefore results in the interpretation that calibration of process parameters are unnecessary.
Considering Process Validation; ref (Sec. 820.75 Process validation)
The implication is that the process variables must be controlled "....monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met. "
creating a product that meets specification requires knowledge of process parameters and associated controls (e.g. time, temperatures, pressures, chemical, etc.)
Can anyone provide more specific citation of the requirements for process controls to be calibrated?
Thanks
The careful reading of 21 CFR 820 Sec. 820.70 Production and process controls. Specifically Sec. 820.72 "Inspection, measuring, and test equipment" sub section (b) is where calibration is listed.
Specific reading of the section could indicate only items used for acceptance activities require calibration. The extension of the concept to processing equipment therefore results in the interpretation that calibration of process parameters are unnecessary.
Considering Process Validation; ref (Sec. 820.75 Process validation)
The implication is that the process variables must be controlled "....monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met. "
creating a product that meets specification requires knowledge of process parameters and associated controls (e.g. time, temperatures, pressures, chemical, etc.)
Can anyone provide more specific citation of the requirements for process controls to be calibrated?
Thanks