Transcription of Q8(R2) - ich.org
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Q8(R2) - ich.org
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE PHARMACEUTICAL DEVELOPMENT Q8(R2) Current Step 4 version dated August 2009 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. Q8(R2) Document History First Codification History Date Parent Guideline: Pharmaceutical Development Q8 Approval of the Guideline by the Steering Committee under Step 2 and release for public consultation.
At a minimum, those aspects of drug substances, excipients, container closure systems, and manufacturing processes that are critical to product quality should be …
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