Implementing A Risk-Based Approach To Calibration

By Joe Leuser, Associate Director, Asset Management & Reliability

The article suggests a risk-based approach to calibration in line with the International Society of Pharmaceutical Engineers (ISPE) Good Automated Manufacturing Practice (GAMP) guidelines. This aligns with the FDA's initiative of a risk-based approach to GMP focusing on product quality and public safety risks. This approach uses information from User Requirement Specifications (URS), validation protocols, and other documents created during the manufacturing process development. Risk assessments of instruments, performed by a team of Process/System Engineer, Calibration/Metrology Specialists, and Quality Assurance, determine criticality, calibration frequency, test points, and tolerances based on scientific data. Instruments are classified as 'critical' or 'non-critical' based on the impact of their failure on business operations, safety, or the environment. Calibration should be done in a specific range and frequency based on risk factors like the impact of a failure on product release, the amount of product re-work acceptable, and the acceptable environmental impact. Extending calibration frequencies can lead to cost savings. The article suggests companies may benefit from a risk-based approach to calibration.