Benefits/Importance of Validation

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• Quality.
• Customer—patient satisfaction.
• It has been built into the product.
• Assurance of quality.
• Time bound.
• Process optimization.
• Reduction of quality cost.
• Nominal mix-ups, and bottle necks.
• Minimal batch failures leads to improved efficiency and productivity.
• Reduction in rejections.
• Increased output.
• Avoidance of capital expenditures.
• Fewer complaints about process-related failures.
• Reduced testing in process and in finished goods.
• More rapid and reliable start-up of new equipment.
• Easier scale-up forms development work.
• Easier maintenance of equipment.
• Improved employee awareness of processes.
• More rapid automation.
• Government regulation.
• Validation requirements is necessary for obtaining approval to manufacture and to introduce new products).

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