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Importance of Validation in Pharmaceuticals


Learn about the benefits of the validation of the different process, systems and equipment in pharmaceutical manufacturing.
Validation is a documented evidence of the consistency of any process or system. It was firstly appeared in 1978 in the United States by the Food and Drug Administration (FDA) to investigate the failure of the product in sterility and now it is a very common concept in the pharmaceutical industries throughout the world.

ValidationNow-a-days validation of all major pharmaceutical systems and processes are very essential. It ensures the quality of manufactured products and helps to manufacture the quality products.

Following are the benefits of the validation of any system or process:
1. Process parameters and controls are determined during the validation of any process or system.
2. It helps to determine the worst case and risks that may arise during the manufacturing of the quality products.
3. Validation helps to investigate the deviations caused during the process.
4. Deep study and understanding of the system and equipment are made possible due to the validation.
5. The risk of the regulatory non-compliance is minimized after the validation.
6. A validated process required less process control and the finished product testing.
7. Batch to batch variation is minimized due to the validation of processes, systems and equipment.
8. Reduces the production cost of the product.
9. Increases the production of manufacturing facility due to the minimized rework and rejection.
10. Decreases the chances of the failure of the batches.


Water system, cleaning of equipment, manufacturing process, HVAC system, analytical method, computer system, autoclave and compressed air system are some systems and processes those validations are required. Other systems and processes those can affect the quality of products are also needed to be validated. All new systems, process and equipment must be validated before are use in commercial production of the products.

Validation is a regulatory requirement of FDA, MHRA, TGA, Schedule M and other regulatory agencies in the world. These agencies focus on the validation of different systems and processes during their regulatory and GMP audits.




Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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