Why do we validate?
Validation demonstrates that a pharmaceutical/medical device or other medical product complies with all quality, safety and efficacy requirements. The validation process is documented evidence that every manufacturing step, for every product and between different batches of the same product, is controlled, documented and meets accepted standards of robustness, repeatability and reliability.
Sampling and testing is not limited to final product only. All production stages overall must be controlled, consistent and comply with all predetermined criteria and specifications.
Smart, rationalized, robust and risk-based validation approaches can significantly decrease the number and costs of routine tests and analyses, as well as improve product quality.
Which industries require validation?
Validation standards have been adopted in most modern industries, including:
- Pharmaceutical and biotechnology
- Medical device
- Veterinary and pet products
- Chemistry and analytical
- Over the counter (OTC) drugs and preparations
- Food and food/dietary supplements
- Software and computerized systems
- Computer science