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Q6A Specifications

Q6A Specifications Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products Chemical Substances (including Decision Trees)... [Pg.60]

International Conference on Harmonization. Guidance on Q6A specifications test procedures and acceptance criteria for new drug substances and new drug products chemical substances. Fed Reg 2000 65(251) 83,041-83,063. [Pg.78]

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]

ICH Q6A, Specifications Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products, Chemical Substances, October 1999, Implementation (Step 5) EU Adopted by CPMP, November 1999, issu as CPMP/ICH/367/96 MHW To be notified FDA Published in the Federal Register 2000 65 (251), Notices, 83,041-83,063. [Pg.112]

Q6A Specifications New Chemical Dmg Substances and Products Page 7 Assay a specific, stability-indicating procedure should be included to determine the content of the new drug substance/drug product... [Pg.143]

See other pages where Q6A Specifications is mentioned: [Pg.333]    [Pg.342]    [Pg.452]    [Pg.16]    [Pg.191]    [Pg.395]    [Pg.59]    [Pg.310]    [Pg.316]   
See also in sourсe #XX -- [ Pg.59 , Pg.310 ]



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