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Supply Chain Integrity (USP)

Biotherapeutics Online Course

The AHC Biotherapeutics Online Course is to provide
basic knowledge on essential elements in Biotherapeutics.

  • Course Guide:
    •   ◎    This online course provides trainings on Biotherapeutics in 5 Parts.
               Please click on each part to select topics of interest.
    •   ◎    Related guidelines for each topic will be shown in the bottom of the page for your
  • Related Guideline

    Related Guideline
    Title Summary PDF
    ICH Q5A(R1) Viral Safety Evaluation of Biotechnology Products Decrived from Cell Lines of Human or Animal Origin
    ICH Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells used for Production of r-DNA Derived Protein Products
    ICH Q5C Quality of Biotechnological Products: Stability Testing of Biotechological/Biological Products
    ICH Q5D Derivation and Characterisation of Cell Substrates used for Productino of Biotechnological/Biological Products
    ICH Q5E Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process
    ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
    ICH S6(R1) Preclinical Safety Evaluation of Biotechnology-Dericed Pharmaceuticals