Stability Testing for New Dosage Forms

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INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE

ICH HARMONISED TRIPARTITE GUIDELINE

STABILITY TESTING FOR NEW DOSAGE FORMS
Annex to the ICH Harmonised Tripartite Guideline on Stability Testing for New Drugs and Products

Q1C

Current Step 4 version dated 6 November 1996

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.

1

Q1C Document History

First Codification

History

Date

New Codification November 2005 Q1C

Q1C

Approval by the Steering Committee under Step 2 and release for public consultation.

29 November 1995

Current Step 4 version
Q1C Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies. 6 November 1996 Q1C

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STABILITY TESTING FOR NEW DOSAGE FORMS
Annex to the ICH Harmonised Tripartite Guideline on Stability Testing for New Drugs and Products ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 6 November 1996, this guideline is recommended for adoption to the three regulatory parties to ICH

1.

GENERAL The ICH harmonised Tripartite Guideline on Stability Testing of New Drug Substances and Products was issued on October 27, 1993. This document is an annex to the ICH parent stability guideline and addresses the recommendations on what should be submitted regarding stability of new dosage forms by the owner of the original application, after the original submission for new drug substances and products. NEW DOSAGE FORMS A new dosage form is defined as a drug…...

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