TABLE I

Why Does Your Company Make Post Approval Changes? (Check All That Apply)

Answer OptionsResponse Percent
Process improvement89%
Expansion/reduction of manufacturing capacity76%
Manufacturing site changes73%
Upgrade or replacement of obsolete equipment71%
Tech transfer69%
Specification/testing change69%
Raw material replacement64%
Regulatory commitment60%
Introduction of innovative technologies60%
Compliance to new regulations53%
Product-related change (e.g., combination product, new formulation)47%
Other (please specify)4%