To keep your Calibration Program on the right track, it’s essential to thoroughly understand your calibration schedule. Every planned calibration event should occur on time, without exceptions. Delays should be identified and addressed promptly, ensuring that equipment is never used for GMP purposes beyond its calibration due date. Neglecting this step could lead to major compliance headaches.

Documenting every aspect of your Calibration Program is pivotal for maintaining compliance. Collaborate closely with your Quality Team to investigate and resolve out-of-tolerance incidents promptly. Implement CAPA (Corrective Action and Preventative Action) plans to ensure deviations are not only identified and addressed but also documented. Proper documentation serves as a safety net against potential compliance issues.

Every piece of equipment used for GMP activities must be part of your Calibration Program. No exceptions. To maintain compliance, your calibration program should be comprehensive and all-encompassing. Regardless of an instrument’s perceived importance or frequency of use, regular calibration is a must to ensure your GMP environment remains compliant.

The backbone of any effective Calibration Program lies in Standard Operating Procedures (SOPs). These procedures should be meticulous, leaving no room for ambiguity. Avoid Vague, generic statements like ‘instruments will be calibrated as needed for compliance.’ Instead, provide detailed, step-by-step instructions that anyone involved in the calibration process can follow. Clarity and precision are your allies in maintaining compliance.

By adhering to the key pillars of an effective Calibration Program you can not only manage your calibration schedule effectively but also mitigate potential risks and ensure compliance in your GMP environment.

If you found our insights useful, we’ve condensed our expertise, experiences, and industry best practices into a comprehensive eBook dedicated to Calibration Excellence. It is a must-have for everyone striving for precision and compliance in the world of GMP.