Transcription of IMPURITIES IN EW DRUG SUBSTANCES Q3A(R2)
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INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE IMPURITIES IN NEW drug SUBSTANCES Q3A(R2) Current Step 4 version dated 25 October 2006 This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA. Q3A(R2) Document History First Codification History Date New Codification November 2005 Q3 Approval by the Steering Committee under Step 2 and release for public consultation.
Impurities in New Drug Substances 3 inorganic impurities in the new drug substance specification should be discussed. Acceptance criteria should be based on pharmacopoeial standards or known safety data. 3.3 Solvents The control of residues of the solvents used in the manufacturing process for the new
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