Module 9 2024

03/09/2024

References I

• ICH Q2 (R1) Validation of Analytical Procedures • ICH 5C Quality of biotechnology products: stability testing of biological products • ICH 5E Comparability of biotechnology.biological products subject to changes in Manufacturing process • ICH Q6B Specifications: Test Procedures and Acceptance Criteria for biotechnological/biological products • ICH Q7 Good Manufacturing practice for API (GMP) • ICH Q8 (R2) Pharmaceutical development • USP Chapters 1032, 1033, 1034.

The Organisation for Professionals in Regulatory Affairs

51

51

References II

USP Chapters

1030 Biological Assay Chapters – overview and glossary

1032 Design and Development of Biological Assays

1033 Biological Assay Validation

1034 Analysis of Biological Assays

The Organisation for Professionals in Regulatory Affairs

52

52

26