Process validation is the process of ensuring that a manufacturing process consistently produces a product that meets its intended specifications and quality requirements. It involves a series of activities that are performed throughout the product lifecycle to verify that the manufacturing process is capable of consistently producing a product that meets the predetermined specifications and quality standards.
The process validation includes three stages:
- The first stage is the process design, in which the manufacturing process is designed, planned, and developed based on product requirements and quality standards.
- The second stage is process qualification, where the manufacturing process is tested and verified to ensure that it is capable of consistently producing products that meet the predetermined specifications and quality standards.
- The third stage is ongoing process verification, which involves monitoring and controlling the manufacturing process to ensure that it continues to operate within the established limits and produces products that meet the specified requirements.
Process validation is essential in ensuring that the manufacturing process produces high-quality products that meet customer expectations and regulatory requirements. It is also critical in maintaining product consistency, reducing product defects and waste, and improving overall manufacturing efficiency.