Metrological Regulations for Quality Control Equipment Calibration in Pharmaceutical Industry

摘要

Drug manufacturing is an extremely regulated industry, where regulatory agencies established actions to assure high quality of pharmaceuticals. Testing final products in laboratory requires adequate facilities and equipment. Error occurrence in measurement of drug physicochemical properties introduces risk in quality of products, which could be harmful for patients. Errors are frequently produced by use of inadequately calibrated instruments. This derived in a need of establishing methods and frequency of calibration. Due to the ambiguity of regulations and continuous technological advances, regulations are not well defined. European and USA Pharmacopoeias are main sources of information for analytical testing, thus, should describe requirements for calibration. Several EP and USP methods require calibration or verification of instruments, but in most cases these operations are not well defined. FDA states that equipment should be calibrated following specific procedures, with defined limits and intervals according to written programs. Because regulations provide inadequate guidance for laboratories, independent organizations release guidelines to promote best practices. Integration of guidelines and standards in regulatory documents would improve calibration procedures and diminish risk of errors.