Quality assurance processes are vital in pharmaceutical manufacturing to ensure that the products are high quality, safe, and effective. Calibration, verification, and validation are three critical quality assurance processes that help ensure the accuracy of measuring instruments and equipment and their capacity according to the specifications.
People often need clarification on these processes. While working in a sensitive industry like the Pharmaceutical Industry, it’s imperative to have a deep understanding of these processes. In this post, we will understand the same.
Differences in Calibration, Verification, and Validation in Pharma Industry
What is Calibration?
Calibration is the process of comparing a measurement device to a known standard. This is done to ensure that the measurement device is accurate and reliable. Calibration is typically performed by a qualified technician using a certified reference standard.
Calibration aims to ensure that measurement devices are accurate and reliable. This is important because accurate measurement is essential for quality control and assurance. If measurement devices are not accurate, the results of measurements will be inaccurate, which can lead to problems with quality control and assurance problems.
Calibration is typically performed regularly, depending on the type of measurement device and the frequency of use. For example, some measurement devices may need to be calibrated monthly, while others may only need to be calibrated yearly.
What is Verification?
Verification is checking that a process or equipment operates according to its specifications. This is done to ensure that the process or equipment is producing the desired results. Verification can be performed by anyone familiar with the process or equipment.
The purpose of verification is to ensure that processes and equipment are operating correctly. This is important because if processes or equipment are not operating correctly, then the results of the process or the equipment output may be incorrect, which can lead to problems with quality control and assurance.
Verification is also performed regularly, depending on the process or equipment type and the use frequency. For example, some processes or equipment may need to be thoroughly checked every month or a week, while others may only need to be verified yearly.
What is Validation?
Validation is the process of ensuring that a system or product meets its intended use. This ensures that the system or product is safe and effective. A qualified team of experts typically performs validation.
Validation is important to ensure that systems and products meet their intended use. This is important because if systems or products do not meet their intended use, they may not be safe or effective, leading to problems with quality control and assurance.
Validation is typically performed on a one-time basis, at the start of a process or project. However, validation may need to be repeated if there is a change in the system or product or a problem with the system or product.
Conclusion
Calibration, Verification, and Validation are critical quality assurance processes in pharmaceutical manufacturing. These processes help ensure that the equipment and instruments used are accurate and reliable, the systems meet predetermined specifications, and the products produced are high quality, safe, and effective.