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Continuous Manufacturing of Drug Substances and Drug Products

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Category

Document

Published on CMKC

Abstract

Guideline gives information and requirements for the production of API in pharmaceutical continuous manufactring processes.

Journal

ICH Q13

Type of publication

Document

Affiliations

  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Article Classification

Guideline

Classification Areas

  • Regulatory

Tags

  1. Changes in Production Output
  2. CM Batch
  3. CM Control Strategy
  4. CM CTD Information
  5. continuous manufacturing
  6. Guideline
  7. Model Considerations
  8. regulatory