The year 2006 marked the 30th anniversary of the formal introduction of process validation concepts and requirements by the US Food and Drug Administration. Despite more than 30 years of common usage, only recently have the theory and practice of validation become fully developed and widely understood, although many misconceptions remain.
Origins of validation
- Epidemic strains were present in numerous areas throughout the manufacturing plants
- Viable microorganisms gained access to the interior of screw-cap closures after the autoclave step of production
- Cooling closures actively drew moisture through the thread interstices into the inner-most depths of the closure
- Transfer of contaminants from closures to fluid was easily effected by simple manipulations duplicating normal in-hospital use (1).