In every manufacturing facility, calibration and validation must be carried out to assure the high quality of the product. You must carry out these processes on a regular basis, rather them being just a one-off activity, if you want to meet all the regulatory requirements. Let us learn more about them.

Calibration – A Brief Overview

Calibration can be defined as a process where a comparison is made between two entities: one whose value has to be measured and the other entity, known as the standard, which is used as the reference in the comparison. This process includes the adjustment of any instrument to bring it into alignment with the standard.

You must carry out instrument calibration on a regular basis to make sure that they produce accurate results. It is important to calibrate:

  • New instruments
  • Before a critical measurement
  • Instruments after a repair
  • After the instrument has been used for a specific number of hours
  • When there is a sudden change in the operating conditions or instrument environment
  • When the measurements seem questionable

What is Validation?

This is a process that ensures that a system, product or service consistently provides results within the acceptable criteria. The performance, quality, and other operating parameters are tested to verify that they comply with the necessary requirements.

Usually, process validation is done by a third party to make sure that the buyer is given a product that meets the specifications, requirements, and accepted standards. Documented results must be produced at the end of the process.

Different Types of Process Validation

  • Prospective Validation

It states that three consecutive marketed batches are manufactured and tested as per the prospective SOP. Prospective validation is conducted before a new product or a product, that is made under a modified manufacturing process, is distributed in the market. This ensures that the modifications made to the product don’t cause a lot of variation in the product’s characteristics. The validation data is generated by the validation committee and unless the data is satisfactory, the product is not released in the market.

  • Retrospective Validation

Based upon the accumulated production, control and testing of data, you can carry out retrospective validation for a product that is already in distribution. This kind of validation is performed by documenting the historical data of the existing products by using trend analysis data. It also ensures that the existing process is under control.

  • Concurrent Validation

All the control activities in the concurrent validation method are performed while the testing is underway in order to approve the method of control. It is carried out during routine production and is effective only if the developmental stages have resulted in a proper understanding of the fundamentals of the process. It is also known as prospective process validation.

  • Locational Validation

When a certain amount of time has elapsed, you have to conduct locational or re-validation for a method that already has been validated.

Difference between Calibration and Validation

Let us understand the basic differences between calibration and validation.

CALIBRATION VALIDATION
Calibration is a process that ensures that accuracy is maintained in the measurements produced by your equipment. Validation is a documented process that provides assurance that a product, service or system consistently provides results within the acceptable criteria.
Calibration performance of any equipment is compared against a reference standard. There are no reference standards used invalidation.
Calibration assures accuracy of measurements. Validation provides proof of consistency across all the processes, batches of products or methods being used.
You must periodically calibrate your instruments. Identify if there is a ‘drift’ in the measurements and eliminate it through calibration. There are no such requirements for validation. It should be performed when you make any change in the existing system or when the revalidation period has reached.
It should be performed as per calibration SOP. It should be performed as per the validation protocol.