Docket Management
Docket: 03N-0059 - Pharmaceutical Current Good Manufacturing Practices for the 21st Century: A Risk-Based Approach
Comment Number: EC -14

Accepted - Volume 1

Comment Record
Commentor Dr. Bruce Ronsen Date/Time 2003-03-14 13:41:24
Organization Pentech Pharmaceuticals, Inc.
Category Health Professional

Comments for FDA General
Questions
1. General Comments since all product manufacturing has risks associated with the process, and since all pharmaceutical companies essentially manage the process and quality risks in producing product for sale, how is the agency proposing to grade the levels of risks and is the impact of the graduation of risk likely to affect the number of companies entering into the an high risk catagory of drug manufacturing? Will the FDA offer incentives to firms conducting high risk manufacturing.




EC -14