The What, Why and How of Calibration in the Pharmaceutical Industry
Did you know that the global Calibration Services market was valued at $3.41 billion in 2013 and is expected to grow at a CAGR of 6.99% between 2014 and 2020? These figures released by the latest MarketsandMarkets report predict the global Calibration Services market to reach $5.58 billion by 2020.
Calibration of equipment, instruments and devices has become an integral part of many different industries including automobile, food, manufacturing, biotech, defense, telecommunications and oil and gas, just to name a few. In my view, the one industry where calibration has become extremely critical is the pharmaceutical industry. Here’s why:
Why is Calibration Important in the Pharmaceutical Industry?
There are a wide variety of reasons that explain why calibration has assumed such a significant role in the pharmaceutical industry. Some of these include:
- Regulatory compliance: The fact that there are stringent FDA and EMEA regulations in place makes the calibration process an uncompromising aspect of the pharmaceutical industry.
- Good Manufacturing Practice (GMP): The FDA mandates adherence to the Current Good Manufacturing Practice (cGMP) standards. These guidelines are framed with an objective of safeguarding the health of patients and consumers of health products.
- Cost-saving and improved efficiency: “Having a well-designed and organized calibration program often leads to benefits in quality, productivity, and increased revenue,” according to Tennessee-based Precision Calibration Systems.
Last and, most importantly, the fact that well-calibrated equipment has a direct impact on human lives. Therefore, such services should not be viewed as an expense, but as an investment.
What to Remember During the Calibration Process
Designated Person: Only trained staff should be allowed to operate equipment, instrument and other devices.
Record Keeping: “Records must be kept of each item of equipment, instrument or other device used to perform testing, verification and/or calibration,” as per a WHO Expert Committee on Specifications for Pharmaceutical Preparations.
Automation is Possible: For efficient outcomes and easy access in the future for audit purposes, a company can explore the use of Calibration Management Systems to automate the entire process. A software-based calibration system can help streamline the entire process of calibration, provide historical trends for analysis and eliminate human errors from the process.
Data Integrity: Impacts of a breach in data integrity can have severe ramifications for a pharmaceutical company. Their licenses can be revoked by the FDA and they also risk losing credibility with existing and potential customers. It is, therefore, important to have ISO/IEC accredited labs undertake the calibration process and a company can opt for one that provides on-site calibration services, if needed.
Frequency of Calibration
Always follow manufacturer recommended guidelines and schedules for calibrating equipment and devices. There might be other reasons that necessitate calibration. These include:
- If the usage is too high, it is advisable to frequently calibrate medical equipment for optimal performance
- Each time a new equipment is brought in, it should be calibrated
- After every repair, calibrate the equipment for accurate performance
- Electrical failure or mechanical malfunction
- When you suspect the accuracy of the results
For every pharmaceutical company, it is critical to document standard operating procedures of the calibration process, create schedules for maintenance, devise an extensive workflow and ensure a robust quality control mechanism to detect and address any anomalies in the system.