This article is limited to the principles of organization for calibration work in relation to cGMP and other pharmaceutical standards. Calibration and metrology methods related to actual calibration techniques, statistics, and theories are not explored in our discussions.1 Each class of instruments requires specific techniques and approaches to achieve stated accuracies. All members of the calibration team should be educated in metrology techniques and skills necessary for the successful calibration work.
In pharmaceutical applications, performance and accuracy of instrumentation devices are governed by Current Good Manufacturing Practices (cGMPs). Verification of proper process instrumentation operation is an important factor for finished product in Quality Assurance (QA) programs. In GPM processes, outside of validated parameters weighing additions, sterilization temperatures, compounding pressures, and other factors are most likely not recoverable and costly to the business. Mistakenly released products within an established QA program could be detrimental to patients’ health and manufacturers’ reputation, including legal implications.
Proper operation of process systems and laboratory equipment in the pharmaceutical environment is critical for product quality, manufacturing cost, and research development. Processes controlled by instrumentation outside of defined tolerances, presumably irreversible, will lead to distraction of affected materials and rise of production costs. Incorrect data of laboratory instrumentation and measurements could delay development and release of new products resulting in potential losses of the market share.
The Product Master File and Batch Records contain information concerning weighing specifications, sterilization requirements, compounding parameters, and other details of scientifically developed process tolerances. Production recipes include sequential order of all process activities and permitted fluctuations. Maximum and minimum temperatures for sterilization, weights of each chemical addition, mixing time, and feeding rates are examples of windows for validated parameters critical in determination of final pharmaceutical product quality.
Precision of data in research and development applications is one of the requirements associated with current Good Laboratory Practices (cGLPs). Good calibration record keeping and maintenance of standards and instruments are necessary for expected reliability of experimental outcomes. Introductions of new drugs to the market could be affected by failures of upholding metrology standards in science laboratories.
Recommendations for Implementing a Calibration Program