About this document
Trs 987 Annex4 by Rami is a document available to read on EtoBox.
The document outlines WHO guidelines for the quality, safety, and efficacy of biotherapeutic protein products derived from recombinant DNA technology, aimed at national regulatory authorities and manufacturers. It includes updated manufacturing and quality control guidelines, as well as new sections on nonclinical and clinical evaluation. The guidelines emphasize the importance of consistency in manufacturing processes and the need for robust testing to ensure product safety and efficacy.
- Author
- Rami
- Language
- EN