Definition of Process Validation

Process validation is crucial for medication production.

Process validation is important to a wide range of industries, particularly that of pharmaceutical production. Without process validation, manufactured products would be both inconsistent and substandard.

Definition

Process validation is a procedure used to ensure that a certain process produces consistent, desirable results over a period of time. It guarantees that a given method for making products allows them to meet predetermined standards in a cost-effective way.

Areas Inspected

When a process undergoes validation, inspectors begin by checking to see that the equipment used in the process operates properly. Then, they check the results to make sure they fully meet quality standards. Finally, they observe the process over a period of time to ensure that the results are consistent.

Results

After observing these three areas, professionals compare the results to see if they match up with a predetermined set of standards. The process is then either validated or adjusted to make it fit the company's requirements.

Pharmaceuticals

Process validation is especially important to the pharmaceutical industry, because drug companies must be certain that their products are consistently identical. Because of this, the FDA strictly regulates process validation in this area.

References

• Visitask: Process Validation
• GHTF: Process Validation Guidance
• FDA: Guidance for Industry
• Residues: Services: Process Validation
• Innovative Solutions: Glossary