Calibration is an integral and essential method for every process and manufacturing industry and plays a vital role in maintaining the accuracy of measuring instruments and devices.
For the pharmaceutical industry, it serves many purposes. The main reason for its importance is that measuring devices and instruments play a critical role in implementing GMP and ensuring quality. Calibration is an effective way of assuring the instrument's performance and accuracy.
The instruments can be vulnerable to deviation and errors without an effective calibration plan. It also becomes difficult to detect defective devices in a timely.
What is the calibration?
Calibration compares an instrument's output with a standard reference value whose output has been verified, free from error and deviations. If the difference between the output of calibrating and the reference instrument is within acceptable limits, the Calibration is said to be satisfactory, and the instrument can be used.
On the contrary, if the difference between the output of calibrating and the reference instrument is outside of the acceptable limit, the Calibration fails, and the instrument is not allowed to be used. In this case, this instrument must be rectified or replaced. After rectification or replacement, the instrument must be re-calibrated. Only when Calibration is satisfactory is the instrument allowed to be used.
After Calibration is performed, its documentation must be completed and maintained because regulatory and standardization bodies review the calibration records. The regulatory bodies can issue a warning if the record is not found.
Who performs the calibration?
The body who performs the calibration should be chosen carefully because it is a critical factor in affecting the overall process of calibration, which then affects the performance of instrumentation system. Like other industries, there are two methods to select calibrating body in pharmaceutical industry, and are - in - house and third party
In - house Calibration
In - house calibration is when a pharma company makes itself arrangement for calibration, and do not send instruments outside. For in-house calibration, the pharma company requires two type of arrangements regulatory and technical
For regulatory requirement, it is necessary to demonstrate that it has all the necessary resources such as Equipment, Skill, and Personal expertise. It enables the pharma company to perform calibration according to the regulatory requirement and accepted by relevant regulatory bodies.
For technical requirements, the organization must contain all necessary equipment, dedicated lab and relevant certifications. Additionally, the equipment used to calibrate other instrument and measuring devices must also be calibrated regularly by third party certified lab.
Third party calibration
In third party calibrations, the instrument are send to third party vendors or labs that have expertise and specialize in performing calibration. The third party vendor or lab must be accredited from relevant standardization bodies to demonstrate their competitiveness in performing calibration activities. . These third part are also responsible to provide relevant documentation, for regulatory bodies during their inspection.
The main advantage of hiring third party vendor or lab is that a pharma company is relieved of extensive activity of accreditation and arranging resources such as calibration equipment, lab and more importantly calibrating their master equipment from authorize certified lab.
Importance of calibration
Let's discuss the importance of calibration and see why it is performed
Regulatory requirement
Calibration is the regulatory requirement for almost all market around the world. These regulatory bodies review calibration documentation during their routine inspection and verify the calibration activity. If they find any deviation or discrepancy, they issue warning until it has been pe...
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