ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products

Title:
ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
Short Title:
Q6B Biotechnological Substances

https://www.gmp-compliance.org/files/guidemgr/3-1-17.pdf

Origin/Publisher:

Document Type:
ICH Guidelines
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.

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