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- Title
International Recommendations, Guidelines and other matters related to the manufacture, quality control and evaluation of biological products.
- Abstract
The article focuses on biological standardization by World Health Organization (WHO) Expert Committee and discussed the need for regulatory frameworks and harmonization in the manufacture, quality control, and evaluation of biological products, particularly focusing on cell, tissue, and gene therapy products, as well as in vitro diagnostic medical devices. Committee also highlights the challenges in regulating diverse and complex products and the importance of regulatory decision-making.
- Subjects
QUALITY control; ORAL poliomyelitis vaccines; MEDICAL equipment
- Publication
WHO Technical Report Series, 2023, Issue 1045, p20
- ISSN
0512-3054
- Publication type
Article