If there is one thing that every pharmaceutical company should never compromise on, it is the quality of their products. Even a tiny variance can lead to life-threatening situations for the users. To ensure the high quality of the end products, all pharma companies must ensure that all of their equipment is well calibrated. At the same time, they must have confidence in the performance and results of the instruments they use to calibrate their manufacturing equipment.
This is where accredited calibration labs come in. These labs ensure that the equipment in pharmaceutical companies is calibrated as per the required standards, which can produce products that match the pharmaceutical quality as set by the regulatory bodies. You will see a distinct difference in the quality and accuracy of the calibration services provided by accredited and non-accredited calibration laboratories. Let’s see what the pharmaceutical companies are subjected to, so that they can deliver high-quality products.
Primary Principles Employed in Pharmaceutical Companies
Pharma manufacturing standards need to undergo 3 principles to achieve high quality:
1. Validation
This refers to the practice of documenting and proving that a procedure or process consistently leads to the expected results. This is a good manufacturing practice where data is collected and analyzed to verify that a process operates within the set parameters. The validation process is done to prove the consistency of the expected results of any process, procedure or method. Additionally, it verifies that the quality standards and compliance are being met by the products in real-time. The validation program assures that a pharmaceutical facility is meeting the pharmaceutical guidelines as set for the industry by the regulatory bodies.
2. Qualification
Validation is mainly concerned with documenting processes. Qualification is the same approach, but it is applied to equipment, systems or machines instead of processes. Qualification can be considered to be a part of the validation process. It can be further divided into Installation Qualification (IQ), Operation Qualification (OQ) or Performance Qualification (PQ).
3. Calibration
This refers to the process where you can determine if an instrument or device is producing accurate results within the specified limits when it is compared to traceable standards of measurement. This is important for justifying the processes of Qualification and Validation.
In this article, we will focus on calibration and other elements associated with it.
What is Calibration?
Calibration can be defined as the technique of correcting or setting a measuring device by adjusting it to match a dependably known and unvarying measure. It can also be considered as an association between measurements —one which is a scale or the accuracy set with one piece of equipment, and another measurement which is made as similar as possible to a second piece of equipment.
The instrument or equipment with the known accuracy is known as standards. All the other instruments are measured against this standard. It is important to know that the standards vary from one country to the other depending upon the type of industry. The manufacturers, on the other hand, assign the criteria for measurement and suggest the level of calibration and frequency depending upon the requirements of their industry, the frequency with which the instrument is used and the specific application.
Calibration Achieves 2 Main Objectives:
1. It checks the accuracy of an instrument
2. It determines the traceability of the measurement
A report showcasing the error in measurements is created during the calibration procedure. When instruments are not calibrated regularly, their quality, safety and consistency are drastically reduced.
Considering the importance of this procedure in various industries, let us take a look at how it all started.
Importance of Regular Calibration
Calibration is responsible for defining the accuracy of any measurement and its quality that is recorded by any instrument. When you start working with any instrument, it must be calibrated well, thus assuring you of accurate results. However, over a period of time you will start observing a ‘drift’. This holds true while using particular technologies or measuring particular parameters such as temperature and humidity. Even overuse, wear and tear, or external factors such as mechanical or electrical shocks may cause a drift in measurements. The drift will occur depending on how quickly the instrument degrades owing to these factors.
Calibration minimizes such uncertainties by assuring the accuracy of the test equipment. When you regularly calibrate your equipment, you can eliminate the drift at its budding stage instead of allowing it to grow till it affects the measurements in significant ways. You need to be confident in the measurements of your equipment at all times, which calls for a regular calibration of equipment throughout its lifetime for reliable, accurate and repeatable measurements.
Calibration helps in quantifying and controlling errors and uncertainties within various measurement processes to an acceptable level. Further, it helps in improving the accuracy of the measuring device, which in turn improves the quality of the end product. In short, regular calibration allows pharmaceutical companies to have confidence in their results which they can record, monitor and control.
When Should You Calibrate Measuring Instruments?
How often you conduct instrument calibration mainly depends upon its tendency to drift from the true measurement and how it impacts the quality of the end product. Examine each instrument being used and study its behavior. Based on this information, you can design a calibration schedule for each instrument. The interval between calibrations can vary as:
- Weekly
- Monthly or bi-monthly
- Quarterly, semi-annually or annually
If the instruments are used quite frequently or when critical measurements are taken regularly, it is advised that calibration is done every week. Some instruments need to be calibrated once or twice every month without fail to ensure that the measurements stay accurate. Some instruments might not be used frequently or do not have the tendency to show a drift easily. They can be calibrated quarterly, semi-annually or annually. Even if the measurements seem accurate, calibrate it regularly. If you notice any change in measurements before the scheduled timeline, calibrate the instrument immediately instead of waiting for the scheduled date.
MAXIMIZE MEASUREMENT ACCURACY WITH OUR CALIBRATION SERVICES
Your products and services can only be as precise as the tools you use to measure. As the global leader in calibration services, we provide precision calibration expertise in every industry, domain and instrument across the world. Our 780+ accreditations in 28 metrological and test domains guarantee quality and reliability.
The post What is pharmaceutical calibration and why is it important? appeared first on Trescal Worldwide.