Scaled-Down Models for PuriŒcation Processes: Approaches and Applications

A complete process validation package is a major component of any regulatory Œling. Regulatory agencies have published general guidelines to aid in developing validation strategies [1,2]. The process validation package consists of systematic documentation of protocols, reports, and results from well-planned studies. The key to successful process validation studies is ensuring strong scientiŒc rationale while maintaining CGMP (current good manufacturing practice) compliance.