Skip to main content
Join CMKC members for a complimentary virtual event on December 10, 11am ET: CM MythBusters: https://bit.ly/3YXJynA. This is a fantastic opportunity to connect, collaborate, and debunk common myths about continuous manufacturing!
18.190.253.56

Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)

View Resource (HTM)

Category

Document

Published on

Abstract

Guideline establishes reuqirements for the synthesis/production of API in primary pharmaceutical manufacturing.

Journal

ICH Q11

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. Control Strategy Principles and Approaches
  2. Guideline
  3. Manufacturing Process Development
  4. Process Validation
  5. regulatory