Last Updated on July 22, 2023 by The Health Master
In the pharmaceutical industry, ensuring the accuracy and reliability of equipment and instruments is crucial for maintaining product quality and regulatory compliance.
This article aims to clarify the key differences between validation and calibration, presenting the information in a tabular format for easy comprehension.
Comparison of Validation and Calibration:
|Process of evaluating and documenting evidence to ensure that a system, equipment, or process consistently produces results within predetermined specifications, thus demonstrating its fitness for the intended purpose.||The process of adjusting and verifying the accuracy and precision of equipment or instruments by comparing their measurements to a known standard.|
|To confirm that a system or process consistently meets its predetermined requirements, thus ensuring its compliance with regulations and industry standards.||To ensure that the measurements obtained from equipment or instruments are accurate and reliable, reducing uncertainties in test results.|
|Applies to systems, equipment, processes, and methods used in the production, testing, and storage of pharmaceutical products.||Primarily focused on instruments and equipment used for measurement, monitoring, and control.|
|Key Activities||Key Activities|
|Establishing performance specifications and acceptance criteria.Executing protocols and tests to generate data.Documenting evidence and generating reports||Comparing measurement values obtained from the instrument with known standards.Adjusting or calibrating the instrument if necessary.Documenting calibration activities and results.Generating calibration certificates.|
|Validation is typically performed during the initial qualification of a system or process and subsequently at defined intervals to ensure continued compliance.||Calibration is performed at regular intervals based on the criticality and usage of the instrument. The frequency can range from daily to annual, depending on factors such as regulatory requirements, instrument stability, and historical performance.|
|Regulatory Requirements||Regulatory Requirements|
|Validation is often mandated by regulatory agencies, as part of good manufacturing practices (GMP) for the pharmaceutical industry.||Calibration is also mandated by regulatory agencies to ensure the accuracy of instruments used for critical measurements. It is typically required for compliance with Good Manufacturing Practice (GMP)|
|Validation demonstrates that a system or process consistently produces the desired results, providing assurance of product quality and regulatory compliance.||Calibration ensures the accuracy and reliability of instrument measurements, reducing uncertainties and ensuring data integrity.|
|Examples of Instruments||Examples of Instruments|
|Manufacturing equipment (e.g., tablet presses, sterilizers).Analytical instruments (e.g., HPLC systems, spectrophotometers).Temperature-controlled storage units (e.g., refrigerators, stability chambers).||ThermometersPipettespH metersBalancesPressure gauges|
While validation ensures that systems and processes consistently meet predetermined requirements, calibration focuses on verifying the accuracy and reliability of instruments.
Understanding the distinctions between validation and calibration helps pharmaceutical professionals implement appropriate measures to ensure accurate measurements, reliable processes, and high-quality pharmaceutical products.
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