Documentation Enquiry.
By definition, validation is the establishment of documented evidence that provides a high degree of assurance that a specific process will consistently produce a product that meets its predetermined specification and quality attributes. That is the frame work in which validation exists. Validation can never be absolute, just as in the aircraft industry they can never guarantee that an aircraft will never fail, so, in the pharmaceutical field failures will occur. Validation is there to reduce the chance of a failure to the lowest possible level.

Since then, the FDA, and the industry have been actively, working together to shape the new quality requirements and standards. Compliance now requires a quality systems approach starting with “quality by design” in development and ending with scientific process control in manufacturing.
So today, products are more complex; cash is scarcer; and quality requirements require more fundamental understanding.
Pharmaceutical companies need to take action on each of these issues in a comprehensive manner.