Continuous Manufacturing of Drug Products Opportunities and Challenges
One of the innovations in the field of pharmaceutical manufacturing has been continuous manufacturing. The talk will outline the concept, features, potential benefits and control strategies used for continuous manufacturing. Quality/ GMP considerations for implementing continuous manufacturing in the small molecules space along with a key factor- how to bridge existing batch manufacturing with continuous manufacturing, would be addressed. Regulatory and Quality Considerations including a summary of current regulatory environment, relevant regulations and guidelines including industry stand on current guidances would be discussed. Quality/GMP Considerations and Post-approval implementation would also be explored in the talk.
Language:
English
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