Validation

We may say that validation is the foundation of CGMP. The regulatory life cycle for validation requirements can be compared to a quality improvement spiral; as we move upward in the spiral, the truthfulness of CGMP is approached (however, it may be never reached, if it is ever reached, then we do not need the FDA). Our Web-site will include information, regulation, case-studies, and knowledge on:

• Process validation,
• Water system validation,
• Methods validation,
• Cleaning validation,
• Computer system validation,
• Software validation,
• Competency training validation,
• 21 CFR Part 11 validation,
• DQ-IQ-OQ-PQ.

It has been estimated that the industry spends over $50 billion a year on validation, that is on converging to true CGMP. If we look at the Warning Letter statistics, we may wonder where did all that money go?

We intend to dissect and analyze the anatomy of validation and try to understand the problems we all face.