Guidance 14: Stability Testing for Prescription Medicines

Previously ARGPM 14: Stability Testing

Version 1.0
Topic

Marketing authorisation procedures

Date

Jul-2013

Overview

This Guideline is part of the updated Australian Regulatory Guidelines for

Prescription Medicines (ARGPM). It identifies the European Union
guidelines for stability testing that have been adopted by the TGA for
testing the drug substance and the medicine. It also explains additional
information that may be required to include in Module 3 of the Common
Technical Document (CTD) to demonstrate stability of the medicines
under Australian conditions.
This guideline identifies the types of medicines that require stability
testing, provides guidance on stability testing for chemically derived and
biological medicines, indicates the specific requirements on stability of
chemically derived medicines, specifies stability data for biological
medicines, and determines the common issues that may lead to requests
for further information and delays in approval of a shelf life for medicines.

Link to Full Text

http://www.tga.gov.au/guidance-14-stability-testing-prescriptionmedicines

Related Resources

Guideline History: Australian Regulatory Guidelines for Prescription

Medicines (ARGPM) (IDRAC 152399)

Content

Introduction
14.1 What medicines require stability testing
14.2 General guidance on stability testing for chemically derived and
biological medicines
14.2.1 The purpose of stability testing of drug substances and
medicines
14.2.2 Stability testing of a drug substance
14.2.3 Stability testing of a prescription medicine
14.2.3.1 Specific stability requirements for Australian climate
14.2.3.2 Photostability studies
14.2.4 In-use stability testing on medicines for multi-dose use
14.2.5 Stability tests for reconstituted and/or diluted prescription
medicines
14.2.6 Effects of the container, container closure and delivery
device on the stability of medicines in liquid form
14.2.7 Preservative efficacy for medicines
Related guidance and information
14.2.8 Presenting data on stability in an application to register a
prescription medicine
14.3 Specific requirements on stability of chemically derived medicines
14.3.1 Predicting shelf life from stability data
The maximum extrapolated shelf life for a medicine
14.3.2 Extending the shelf life of individual batches of chemically

derived medicines
14.3.3 Self-assessable request for shelf-life extensions
14.4 Specific requirements on stability of biological medicines
14.4.1 Stability testing for biological medicines
14.4.2 Predicting shelf life of biological medicines from stability
data
14.4.3 Stability data to include in an application for a biological
medicine
14.5 Common deficiencies in stability data and trial design
14.5.1 Issues with batch information
14.5.2 Issues with stability trial conditions and/or design
For biological medicines
14.5.3 Issues with analytical methodology/testing
14.5.4 Issues with data reporting and evaluation

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