Process Validation

Process validation includes those considerations that should be made before a product is introduced or when there is a change in the manufacturing process which may affect the product's characteristics, such as uniformity and identity. The following are considered as key elements of process validation.

Equipment and Process

The equipment and processes should be designed and/or selected so that product specifications are consistently achieved.

• Equipment: Installation Qualification - Installation qualification studies establish confidence that the process equipment and ancillary systems are capable of consistently operating within established limits and tolerances.
• Process: Performance Qualification - The purpose of performance qualification is to provide rigorous testing to demonstrate the effectiveness and reproducibility of the process.
• Product: Performance Qualification - It is necessary to demonstrate that the specified process has not adversely affected the finished product.

System to Assure Timely Revalidation

• There should be a quality assurance system in place which requires revalidation whenever there are changes in packaging, formulation, equipment, or processes which could impact on product effectiveness or product characteristics, and whenever there are changes in product characteristics.

Documentation

• It is essential that the validation program is documented and that the documentation is properly maintained.