What are the processes involved in process validation?

The Three Stages of Process Validation are: Stage 1 – Process Design. Stage 2 – Process Validation or Process Qualification. Stage 3 – Continued Process Validation.

What is the purpose of process validation?

The purpose of process validation is ultimately to demonstrate with a high degree of assurance that the process can produce products that can be consistently manufactured while meeting predetermined specifications within stated parameters.

What is validation in pharmaceutical company?

The validation process is the documented evidence which provides a high degree of assurance to a desired result with predermined compliance. The term validation is widely used in pharmaceutical industries. This term comes from the word “valid or validity” which means “legally defined”.

Why do we require validation in pharma?

Nowadays 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. It helps to determine the worst case and risks that may arise during the manufacturing of the quality products.

What are types of validation?

There are 4 main types of validation:

• Prospective Validation.
• Concurrent Validation.
• Retrospective Validation.
• Revalidation (Periodic and After Change)

WHO guideline for process validation?

961, Annex 6 (3).) A risk‑based and life‑cycle approach to validation is recommended. Thorough knowledge of product and process development studies; previous manufacturing experience; and QRM principles are essential in all approaches to process validation, as the focus is now on the life‑cycle approach.

What is drug validation?

Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages.