Transcription of Q1A(R2) - ICH
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Q1A(R2) - ICH
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS Q1A(R2) 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.
The intermediate storage condition has been changed from 30°C ± 2°C/60% ... the United States would be mutually acceptable to the other two regions, provided ... container closure system that is the same as or simulates the packaging proposed for storage and distribution.
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