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Q6B Specifications

Q6B Specifications Test Procedures and Acceptance Criteria for Biotechnological/Biological Products... [Pg.60]

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Q6B Specifications Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, 1999. [Pg.19]

In the early days of biotechnology product development, the focus was on quality issues [4] or process-related impurities.The concerns at that time were for carryover of other cellular proteins and DNA and for contamination with endotoxins, chemicals, and viruses. Of course, these concerns still exist, but methods for purification and assays for evaluation of clearance have alleviated the need for the safety assessment scientist to focus on contaminants instead they are now asked to focus on the pharmacological activity of the molecules. An ICH guidance (Q6B Specifications Test Procedures and Acceptance Criteria for Biotechnological/Biological Products) addresses the specific issues related to the manufacturing process [6], Other product-related issues such as impurities do need to be considered by the safety assessment scientist, for... [Pg.113]

ICH. Guidance for Industry, Q6B. Specifications Test Procedures and Acceptance Criteria for Bio-technological/Biological Products. ICH-Q6B, 1999 18 Aug. [Pg.389]

Q6B Specifications test procedures and acceptance criteria for biotechnological/biological substances... [Pg.210]

ICH Harmonised Tripartite Guideline (ICH Q6B) Specifications Test Procedures and Acceptable Criteria for Biotechnological/Biological Products Q6B. Federal Register. 1999, 64 44928. [Pg.251]

See other pages where Q6B Specifications is mentioned: [Pg.715]    [Pg.310]    [Pg.273]    [Pg.362]    [Pg.252]   
See also in sourсe #XX -- [ Pg.310 ]



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