Steps of Process Validation

Definition:

 Process validation is establishing documented evidence which provides a high degree of assurance that a specific process (such as the mfg. of pharmaceutical dosage form) will consistently produce a product meeting its predetermined specification and quality assurance.

Process Validation include:

 Installation Qualification 

Operational Qualification 

Performance Qualification

Installation Qualification
 This ensures that all major processing and packaging equipment, and ancillary systems are in conformity with installation specification, equipment manuals schematics and engineering drawing. It verifies that the equipment has been installed in accordance with manufacturers recommendation in a proper manner and placed in an environment suitable for its intended purpose.

Operational Qualification:

   This is done to provide a high degree of assurance that the equipment functions as intended. determine if the entire system operates as an integrated whole.

Performance Qualification:

 This verifies that the system is repeatable and is consistently producing a quality product.