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

View Resource (HTM)

Category

Document

Published on CMKC

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