Transcription of ICH Q1F Stability Data Package for Registration ...
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ICH Q1F Stability Data Package for Registration ...
ICH Q1F Stability Data Package for Registration Applications in climatic Zones III & IV GI010A gggmmmpppeeeyyyeee 1 INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR Registration OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE III IV ( Stability Data Package for Registration Applications in climatic Zones III & IV) Q1F Current Step 4 version dated 6 February 2003 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. ICH Q1F Stability Data Package for Registration Applications in climatic Zones III & IV GI010A gggmmmpppeeeyyyeee 2 Q1F Document History First Codification History Date New Codification November 2005 Q1F Approval by the Steering Committee under Step 2 and release for public consultation 76 February 2002 Q1F Current St
ICH Q1F Stability Data Package for Registration Applications in Climatic Zones III & IV GI010A ggmmppeeyyee www.gmpeye.co.kr 3 STABILITY DATA PACKAGE FOR REGISTRATION APPLICATIONS IN
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