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The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
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| Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products |
| Short Title: | Q6B Biotechnological Substances |
| Internet: | http://www.ich.org/LOB/media/MEDIA432.pdf |
| Origin/Publisher: | ICH Secretariat, c/o IFPMA, 30 rue de St - Jean, P.O. Box 758, 1211 Geneva 13, Switzerland; http://www.ich.org
als CPMP-Guideline auch unter Internet: http://www.emea.europa.eu/pdfs/human/ich/036596en.pdf |
| Content: | ICH guidelines for the quality of biotechnology products with respect to the specification of new biotechnology substances. With this guideline concerning specifications for biotechnology products ICH (Japan, USA, EU) intends to define uniform standards for the specifications of biotechnology products. |
| Document Type: | ICH Guidelines |
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