Development of the metrology program for a new biotech plant

As part of the construction of a new plant, our client needed a metrology expert to develop procedures and forms for its instruments calibration program.

Genipro was mandated by the client to develop the complete metrology program for its new plant.

Thanks to its metrology expert, Genipro was able to develop the program in accordance with the best practices and standards of the pharmaceutical industry. One of the challenges of this mandate was to support the establishment of calibration frequencies despite the fact that no history was available. Through our experience in the industry, and by applying a risk management approach, we were able to establish which instruments should be part of the calibration program, establish their alert and action limits and their respective calibration frequency. Another important point was to structure the calibration program around the use of a laboratory management system (LIMS) as a computerized calibration management system (CCMS), which is not the primary mission of a LIMS. Our systematic and structured approach allowed us to successfully adapt the procedures to the client's computer system.