Difference between Validation and Calibration in the Pharma Industry

Validation and calibration are essential processes in the pharmaceutical industry to maintain product quality, regulatory compliance, and data integrity.

Rakesh Dahiya

May 26, 2023

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Rakesh Dahiya

SDCO Cum Licensing Authority |
Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com

Introduction:

In the pharmaceutical industry, ensuring the accuracy and reliability of equipment and instruments is crucial for maintaining product quality and regulatory compliance.

Two essential processes involved in this are validation and calibration. Although both terms are often used interchangeably, they have distinct meanings and purposes.

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:

Validation	Calibration
Definition	Definition
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.
Purpose	Purpose
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.
Scope	Scope
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.
Frequency	Frequency
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)
Outcome	Outcome
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

Conclusion:

Validation and calibration are essential processes in the pharmaceutical industry to maintain product quality, regulatory compliance, and data integrity.

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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