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Pharmaceuticals are substances that interact with the immune system of our body. They are mainly used in treating, diagnosing, or preventing diseases. Vaccines, antibiotics, and medicines are some of the major pharmaceutical products. The chemical analysis of the pharmaceutical products or the drugs used in them is termed pharmaceutical analysis. Pharmaceutical analysis is important in identifying, classifying, separating, purifying, or quantifying the different compounds or studying the molecular structure of compounds used to make pharmaceutical products. There are different instruments used for calibration in the pharmaceutical analysis of products. The reason why calibration is important and the importance of instrument calibration and the calibration in the pharmaceutical industry must be known.
Why is calibration important?
There are different instruments used for the process of pharmaceutical analysis. Before they are used, it is important to ensure that these instruments are properly calibrated.
Calibration is the standardisation process of an instrument based on an existing standard. It helps make the instrument set work in a required range while maintaining accuracy. Calibration is mainly done for quality assurance, and every pharmaceutical instrument must be checked periodically to ensure accuracy. Over a period of time, the instruments’ accuracy varies due to several factors, including temperature and how they are maintained.
Importance of instrument calibration
Instruments need to be appropriately calibrated for efficient use. This helps analyse the instrument’s accuracy and set it to a suitable and intended accuracy as per the purpose and need. If the instrument is out of the required range, calibration includes setting it to measure the needed range of values. This is the main reason why calibration is essential, especially instrument calibration. It is essential in cases where the instrument accuracy affects the final product. Calibration finds its importance in the pharmaceutical industry too.
For example, if we are using a screw gauge to measure the thickness of a wire, if the instrument is not calibrated correctly, it shows zero error that must be rectified or compensated to get the accurate value. The same is the case for calibration in the pharmaceutical industry. Since the industry involves manufacturing substances that actively interact with our immune system, extreme care should also be taken in the calibration process. The expenses resulting from using an uncalibrated instrument are exponential compared to the cost of calibration.
Calibration in the Pharmaceutical Industry
The different pharmaceutical products can be analysed biologically, chemically, or biochemically to study their effects and need for concentration. While analysing these products using other instruments, it is extremely important to ensure that the instruments are calibrated according to the purpose.
When and how to Calibrate?
An instrument must be calibrated according to the manufacturer’s recommendations based on the product features and capabilities. If the instrument undergoes any electrical or mechanical shock, it must be checked to see whether it is out of order and calibrated if needed. The importance of instrument calibration in the pharmaceutical industry is notable. So, the instruments must be calibrated annually, quarterly or monthly as per the frequency of use.
According to the type and number of instruments tested, calibration can be performed by either sending the instruments to a laboratory or an in-house test. Ensuring that the labs performing calibration are accredited to the standards followed for accurate results is necessary. The results obtained from the instrument are to be calibrated compared with the results of a standard instrument set to maximum accuracy. The deviation from standards is noted and adjusted to correct it to standard values.
Calibration Standards
ISO 9001 is a quality standard followed by accredited companies to calibrate measurements. It also involves documenting the entire process and involved procedures. It is a quality management standard that organisations can use irrespective of their field of activity.
ISO/IEC 17025 is the laboratory’s quality standard where calibrations are done. IEC stands for International Electrotechnical Commission. It ensures that the results produced are valid and match the standard values.
Conclusion
Pharmaceutical analysis is the process of analysing drugs or pharmaceutical products. There are different instruments used in the analysis of these drugs or products. But these instruments need to be appropriately calibrated to obtain accurate results. This is extremely important in the case of pharmaceuticals as they directly impact the final product and its subsequent effects. Calibration is essential to ensure that the instrument is suitable for the intended purpose. Instruments are usually calibrated before first use when the measurements look questionable or in case of sudden shock.
