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Q8, pharmaceutical development

ICH Q8. Pharmaceutical Development. ICH Harmonised Tripartite Guideline, Current step 4 version, November, 2005. http //www.ich.org/fileadmin /PublicWebSite/ICHProducts/... [Pg.42]

Since late 2005, the ICH has added three more quality guidelines Q8— Pharmaceutical Development, Q9—Quality Risk Management, and QIO— Pharmaceutical Quality System. All these guidelines are intended to bolster the quality of drugs to be manufactured, steering manufacturers in the direction to improve compliance, safety, and consistency of the drugs. [Pg.287]

Three consensus guidelines define the core of the ICH s involvement in harmonization of pharmaceutical quality systems—Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality Systems (in addition, each of the guidance documents cites critical areas of overlap with Q6A Specifications Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products Chemical Substances). [Pg.333]

International Conference on Harmonization (ICH) (2004), Q8 Pharmaceutical development, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH, Geneva. [Pg.351]

International Conference on Harmonization. 2006. Q8 Pharmaceutical Development. http //www.fda.gov/cder/guidance/index.htm. Accessed June 8, 2007. [Pg.46]

According to ICH Guideline Q8 Pharmaceutical Development, the marketing authorization application (MAA) should discuss the excipients chosen and their concentration. The MAA should show the characteristics that can influence the medical product performance and manufacturability relative to the respective function of each excipient. Additionally, the MAA should demonstrate the ability of excipients to provide their intended functionality throughout the intended period of validity of the formulation. Use the information on excipient performance as appropriate to justify the choice and quality attributes of the excipients.26... [Pg.228]

International Conference on Harmonization (ICH) (May 2006) Guideline Q8, pharmaceutical development. [Pg.114]

ICH guideline Q8 (Pharmaceutical development) is also called Quality by Design (QbD) and it guides how to build... [Pg.779]

The concepts of QbD and Design Space are already included in the ICH directives, concretely in the ICH Q8 Pharmaceutical development. Therefore, the regulatory agencies are already asking for the pharmaceutical industry to fulfill these directives. [Pg.135]

See other pages where Q8, pharmaceutical development is mentioned: [Pg.60]    [Pg.17]    [Pg.563]    [Pg.529]    [Pg.333]    [Pg.29]    [Pg.5]    [Pg.324]    [Pg.112]    [Pg.356]    [Pg.435]    [Pg.528]    [Pg.102]   
See also in sourсe #XX -- [ Pg.197 , Pg.198 , Pg.199 , Pg.435 , Pg.528 ]



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Q8, pharmaceutical

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