Pharmaceutical manufacturing standards tend to be much higher than those of other health-related sectors. Regulatory authorities heavily monitor each and every process. The Good Manufacturing Practice or GMP guideline states that pharmaceutical companies are required to conduct instrument calibration on a regular basis as part of their qualification and validation activities.
What Is Calibration? How Does Calibration Differ From Adjustment?
Calibration is the process of comparing an instrument’s test measurements against a standard that is considered to be highly accurate. To determine the accuracy of the instrument, traceability and reliability is conducted on the former. This test is usually conducted under a very specific set of conditions, known as operating conditions, in which procedures can be easily retested and reproduced if necessary.
Adjustment is the act of altering or making changes to an instrument that has been deemed faulty so that it once again “reads true.” An adjustment can invalidate a calibration that occurred previously. To protect from any type of deviations, equipment must be recalibrated after it has been aligned or adjusted to ensure that the instrument does not affect production efficiency or the overall quality of the work that it will perform.
Why Is Calibration Important?
Good distribution practice in Singapore is undergone to ensure the accuracy of measurement tools within a set of controlled limitations. Results are always stated in the standard specified unit and numerical value based on the system of metrology that is being used.
The standardised unit will vary greatly based on the devices and systems used for this calibration process. Each of these devices used in testing needs to function at absolute precision to ensure the utmost accuracy of other instruments.
Adhering to measuring and instrument calibration standards helps pharmaceutical companies maintain GMP and quality assurance compliance in three very important ways.
- Accuracy: The overall accuracy of instrument readings affects very important decision-making processes. False or incorrect measurements can lead to issues in compliance, safety, and quality.
- Traceability: Measurements recorded from a specified instrument need to remain consistent with measures taken from other instruments that are similar in nature. This allows for a greater control during the production, testing, and validation process. To allow these readings to be comparable regardless of location, either the recognised national or international metrology systems need to be followed.
- Reliability: In order to properly validate pharmaceutical products, measuring instruments need to be reliable and established. Some devices required for complex tasks require a higher accuracy than other instruments. Both cost and quality have an impact on the instrument’s reliability.
To maximise the reliability of your pharmaceutical measuring instruments, it’s important to calibrate instruments regularly while locating potential areas of fault and correcting them in a timely manner.