About Shahid Ali Expertise I can answer about all validation and qualification activities like Equipment qualification, analytical method validation, process validation, calibration and verification, Machine capability study, stability studies, cGMP, GVP, GDP, QMS, TQM, ISO and Regulatory affairs.
Expert: Shahid Ali Date: 4/10/2008 Subject: Calibration
Question Hi Shahid,
I would be extremly greatful if you could answere the following question:
“Explain why calibration is a GMP requirement and how a Calibration system fits into the overall quality system in a manufacturing environment”.
thank you,
Tom
Answer The intent of the GMP calibration requirements is to assure adequate and continuous performance of measurement equipment with respect to accuracy, precision, etc. The calibration program implemented by a company may be as simple or as sophisticated as required for the measurements to be made. Some instruments need only be checked to see that their performance is within specified limits, while others may require extensive calibration to a specification. The difference between calibration and Verification is that in verification only confirmance to system is done while in calibration adjustment is done against the standard. The QS regulation requires in section 820.72(b) that equipment be calibrated according to written procedures that include specific directions and limits for accuracy and precision.
The Quality System (QS) regulation requires that each manufacturer develop, conduct, control, and monitor production processes to ensure that the end device conforms to its specifications [820.70]. All equipment used to manufacture a device shall be appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use [820.70(g)]. The degree of maintenance on equipment and the frequency of calibration of measuring equipment will depend upon the type of equipment, frequency of use, and importance in the manufacturing process. Where deviations from device specifications could occur as the result of manufacturing processes, the manufacturer shall establish and maintain process control procedures.
