ABSTRACT
QC laboratories should ensure that analytical instrument, including mechanical, electronic, automated, chemical or other equipment, are
• Suitable for the intended use in the design, manufacture and testing of components
• Capable of producing valid and reproducible results • Operated by trained and experienced analysts • Properly calibrated versus a suitable standard
To succeed, the quality system shall include a calibration program that is at least as stringent as that required by the QS regulation (820.72). The intent of the GMP calibration requirements is to assure adequate and continuous performance of measurement equipment with respect to accuracy and precision, and so on.
