(76c) Drug Product Continuous Manufacturing Control Strategy Considerations
AIChE Annual Meeting
2016
2016 AIChE Annual Meeting
Pharmaceutical Discovery, Development and Manufacturing Forum
Forum Plenary: Pharmaceutical Discovery, Development, and Manufacturing Forum
Monday, November 14, 2016 - 9:00am to 9:30am
This presentation will cover the key components of a fully automated drug product continuous manufacturing control strategy. In-process control, real time decision making, sampling plans and sampling plan justification, and real time release testing will be discussed. Experience with filings and inspections along with a few learnings and considerations for continuous manufacturing will be shared.