Stability Services

CMG’s experts can design a protocol for your product. Listed medicines may be subject to a compliance review at any time while they remain on the Australian Register of Therapeutic Goods (ARTG). This allows the Therapeutic Goods Administration (TGA) to determine the compliance of these medicines with relevant regulatory requirements. Sponsors are required to certify that they hold relevant records (such as stability information) to meet quality requirements for their medicine when listing it on the ARTG. 

What sponsors of listed medicines need to do

If you are a sponsor of a listed medicine, you should ensure that:

• prior to or at the time of listing, you hold information or evidence to show that your medicine’s specifications will be maintained under the conditions set out on the medicine’s label until the medicine’s expiry date
• you review the data that you hold with respect to the stability of your medicine against relevant requirements

Stability study protocol

The predetermined protocol is designed specifically for the finished product and the target market country using stability-indicating validated analytical methods.

Types of testing

Physical testing parameters

Include physical testing parameters specific to the medicinal product, including pack integrity.

Microbiological testing

Consider microbiological testing throughout the study to support compliance with the expiry specifications.

Active ingredients labelled quantitatively

Test the active ingredients that are claimed on the label quantitatively throughout the study using validated stability-indicating methods.

Target market countries

Conduct the ongoing stability program in line with the regulatory guidelines for the countries of destination. The testing requirements and storage conditions in the study design must meet the regulatory requirements of the countries the product will be sold into.
The different regulatory requirements of different countries need to be considered when a sponsor first commences the stability program.

Conditions

Conduct stability testing in real time at the storage conditions specified on the product label. For example, when the label storage conditions are:

• ‘store below 30°C’, conduct studies at 30 ± 2°C and 65 ± 5% relative humidity
• ‘store below 25°C’, conduct studies at 25 ± 2°C and 60% ± 5% relative humidity
• ‘store below 8°C (refrigerate)’, conduct studies at 5 ± 2°C

Other incubation conditions may need to be considered for export countries depending on their regulatory requirements.

Monitoring the stability study

At each time point, report and review the results of the stability study. Review the data to identify out-of-trend (OOT) and out-of-specification (OOS) results.

Compare all data from the previous time point with the latest reports to identify any significant changes in the product.

For information on our Stability Services, please contact us at info@cmgrouponline.com.au

References

• Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice for Medicinal Products Introduction
• Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice for Medicinal Products Part I
• Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice for Medicinal Products Part II
• Complying with the PIC/S Guide to Good Manufacturing Practice for medicinal products
• Understanding quality requirements for listed medicines
• Australian Regulatory Guidelines for Complementary Medicines
• Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019
• Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018