SOCIAL QUESTIONS|health|pharmaceutical industry
- eisíontas a bhaineann le próiseas Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- process-related impurity | process-related impurities
- en
- Sainmhíniú impurity that is derived from the manufacturing process Tagairt "European Medicines Agency (EMA). 'ICH Topic Q 6 B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. Step 5. NOTE FOR GUIDANCE ON SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS (CPMP/ICH/365/96)' (21.1.2021)"