Process Validation – Concept
In this article, we are going to learn the concept of process validation in concise . Validation is an act of proving right with documented evidence, suppose you create a new password, and the system to validate your password, asks you to re-enter so that you are confident about your password wise process validation is done to ensure the process consistently produces products with predetermined specifications and quality attributes. and process validation is a step-by-step process.
When is Process Validation done?
- Introduction of new product in a facility
- Changes made in the already existing product
- Periodic verification
Steps in process validation
- Process design
- Process Qualification
- Continued process verification
Let’s dive deep to understand the concept
Process Design: Here the process is designed to suit the commercial operations based on the knowledge obtained in the development and scaleup activities. This step is very important, and all aspects must be taken into consideration while designing the process as we are expecting to produce the product on a commercial scale, The next step is process qualification.
Process qualification: PQ is performed to know whether the designed process is meeting the requirements like reproducible results suitable for commercial scale production. it has two aspects , first consideration is regarding design of facility , equipment and its qualification,and second one is process performance qualification .
Continued Process Verification: The main reason for CPQ step is to assure that the process remains same in the sense of producing products with predetermined specifications and quality attributes, this is done by monitoring of the production batches regularly.
Process validation is done on the basis of the knowledge and data from the product development and the product, in order to process validation, the validation team should understand the product and its development thoroughly. This amount of understanding will route us to develop a process that is capable of consistently producing the products with predetermined specifications and quality attributes.
All the activities must be performed according to the cGMP .