Stability
Testing for New Dosage Forms
Annex to the ICH Harmonised Tripartite
Guideline on
Stability Testing for
New Drugs and Products
Q1C
Document History
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).
(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.