Transcription of IMPURITIES IN EW DRUG SUBSTANCES Q3A(R2) - ICH
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IMPURITIES IN EW DRUG SUBSTANCES Q3A(R2) - ICH
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. 15 March 1994 Q3A Q3A Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies.
impurities found in batches manufactured by the proposed commercial process. Those individual impurities with specific acceptance criteria included in the specification for the new drug substance are referred to as "specified impurities" in this guideline. Specified impurities can be identified or unidentified.
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