It goes without saying that calibration is extremely important in the manufacturing process to produce high-quality products. The importance of calibration in the pharmaceutical industry is equally high as low-quality products put the lives of consumers at risk. Instrument calibration and accuracy is very critical to product safety and quality. At the same time, one has to ensure compliance. Strict calibration practices will not only guarantee a safe product but also help in minimizing costs that are associated with damaged batches and associated fines.
Importance of Instrument Calibration in Pharmaceutical Applications
Instrumentation calibration and equipment validation are responsible for determining the accuracy and performance of the instruments and sensors used in pharmaceutical applications. Calibration should be done in a regulatory environment, adhering to the strict EMEA/FDA regulations and ISO standards. Regulatory bodies need to know if the instruments are capable of producing accurate measurements so that the quality of the products is not affected, considering it can affect the health of thousands of people. The concerned regulatory bodies check the extent of inaccuracy of an instrument, if any, when measured against specified tolerance levels and calibrate it accordingly.
Benefits of Calibration Management Software
Managing, recording and storing calibration data can be quite a task if done manually. With calibration management software system, the process gets more streamlined and much simpler. You can locate records with ease and verify that all the systems are working as designed by automating the process. When you incorporate calibration management software, you improve plant efficiency and minimize the instances of unforeseen instrument failures. This reduces the chances of extended downtime, which automatically increases productivity. Calibration management software allows you to access required information with ease, which is a necessity in crucial instances such as audits.
How Important is Instrument Traceability?
Calibration is incomplete without traceability. Certain instruments have to be measured against the relevant corresponding national standard. The organization has to provide evidence that their products conform to the required standards as set by the regulatory bodies. To achieve this, appropriate monitoring and measurements of the measuring devices should be conducted.
Manual Vs Automated Documentation
By switching from manual documentation to an automated one will offer numerous benefits. It is important that all the measurement and monitoring practices employed by the organization are consistent with monitoring and measurement requirements set by regulatory bodies. By documenting the calibration records, companies can analyze their calibration history trends.
You can use a documenting calibrator to store the results automatically to the calibrator’s memory, which can then be transferred to a database with ease. This eliminates the need for manually entering the data, making the documentation process much faster and easier. It elevates the accuracy and efficiency as well. Do not make documentation an afterthought and start the process alongside with calibration. By having an automated and paperless documentation, companies can save an incredible amount of time and money.
What are Instrument Calibration Regulations?
Calibration regulations vary from one country/continent to the next. For example, in Europe the industry calibration requirements fall under the jurisdiction of the EMEA (European Medicines Agency), as well as local legislation and in the US, calibration is overseen by the FDA (the US Food and Drug Administration) regulations.
Every pharmaceutical company has to abide by the regulations set by either EMEA or FDA, depending upon their location. They need to keep their calibration records up-to-date and carry out all the calibration processes as per the exacting standards of written, approved procedures. Every instrument should have a unique ID, physically tagged and color-coded. In addition to that, it should also have a master history record.