Instrument Calibration in Pharmaceutical Applications

Why should calibration be more rigid and frequent in Pharmaceutical applications?

As we know, calibration determines how accurate an instrument or sensor is performing. Despite the fact that the vast majority of instruments today are highly accurate, regulatory bodies still need to know the exact extent of an instrument’s inaccuracies, measured against specified tolerance levels. Clearly this is of paramount importance to the exacting nature of applications in the Pharmaceutical sector. When the health of thousands of people could be adversely affected, as a direct result of instrument failure or human negligence, the pressure is on to achieve the highest standards of accuracy possible. Little wonder then that pharmaceutical manufacturing is one of the most rigorous and heavily regulated industries in the world.

Calibration in an Regulatory Environment

Pharmaceutical plants cannot function without  calibration. However, adhering to the stringent EMEA/FDA regulations and ISO standards, not to mention the vast quantity of instruments requiring regular calibration, can be a time-consuming and costly process. Large amounts of calibration data is produced and archived, which must be easily accessible, particularly in the event of an audit.

Instrument Traceability

Traceability is also an important factor in calibrations. Particular instruments need to be measured against the relevant corresponding national standard. The appropriate monitoring and measurements, and required measuring devices, are determined by the organization themselves to evidence a product’s conformity to standards.

What are the Instrument calibration regulations?

Manufacturers are duty bound, by EMEA and FDA regulations, to keep their calibration records up to date and execute instrument calibration to the exacting standards of written, approved procedures. It’s also imperative that every instrument in the plant should have a master history record. As well as this unique ID, all product, process and safety instruments should be physically tagged and color-coded. Manufacturers should also set a calibration period and error limits for each instrument. These should tally with national and international standards and must be more accurate than the required accuracy of the equipment being calibrated. Personnel must also be properly trained and competent to carry out calibration work and should be able to provide documented evidence of this. It is also vitally important to implement a documented change management system.