ICH Guidelines

 The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an international organization that develops and promotes harmonized guidelines and standards for the development, registration, and post-approval of pharmaceutical products. The ICH guidelines cover a wide range of topics related to drug development, including quality management, nonclinical and clinical studies, pharmacovigilance, and the use of statistical methods in data analysis. Some of the most well-known ICH guidelines include:

  1. ICH Q1A(R2): Stability Testing of New Drug Substances and Products
  2. ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology
  3. ICH Q3D: Guideline for Elemental Impurities
  4. ICH Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
  5. ICH Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
  6. ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
  7. ICH Q8(R2): Pharmaceutical Development
  8. ICH Q9: Quality Risk Management
  9. ICH Q10: Pharmaceutical Quality System
  10. ICH E6(R3): Guideline for Good Clinical Practice.

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