Stability Testing for New Dosage Forms



Stability Testing for New Dosage Forms
Annex to the ICH Harmonised Tripartite Guideline on
Stability Testing for New Drugs and Products


Q1C
Document History


First Codification
History
Date
New Codification
November 2005
Q1C
Approval by the Steering Committee under Step 2 and release for public consultation.
29 November 1995
Q1C
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

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.
2.    NEW DOSAGE FORMS
A new dosage form is defined as a drug product which is a different pharmaceutical product type, but contains the same active substance as included in the existing drug product approved by the pertinent regulatory authority.
Such pharmaceutical product types include products of different administration route (e.g., oral to parenteral), new specific functionality/delivery systems
(e.g., immediate release tablet to modified release tablet) and different dosage forms of the same administration route (e.g., capsule to tablet, solution to suspension).
Stability protocols for new dosage forms should follow the guidance in the parent stability guideline in principle. However, a reduced stability database at submission time (e.g., 6 months accelerated and 6 months long term data from ongoing studies) may be acceptable in certain justified cases. 


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