Why Does Your Company Make Post Approval Changes? (Check All That Apply)
Answer Options | Response Percent |
---|---|
Process improvement | 89% |
Expansion/reduction of manufacturing capacity | 76% |
Manufacturing site changes | 73% |
Upgrade or replacement of obsolete equipment | 71% |
Tech transfer | 69% |
Specification/testing change | 69% |
Raw material replacement | 64% |
Regulatory commitment | 60% |
Introduction of innovative technologies | 60% |
Compliance to new regulations | 53% |
Product-related change (e.g., combination product, new formulation) | 47% |
Other (please specify) | 4% |