Q8(R2) - ICH

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. 18 November 2004 Q8 Approval of the Guideline by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies. 10 November 2005 Annex to the Parent Guideline: Pharmaceutical Development Annex to Q8 Approval of the Annex by the Steering Committee under Step 2 and release for public consultation.

Pharmaceutical Development 2 i.e., quality should be built in by design. Changes in formulation and manufacturing processes during development and lifecycle management should be looked upon as

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