Stability Testing

In July 2009 compliance with the quality control section of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products became a legal requirement.

stability testingPost July 2011 it will not be possible to have your product released for sale unless your manufacturer or release for sale agent has your compliant stability on hand.

Even if you have the data to justify your two or three year shelf life you now have to perform ongoing stability studies in addition to this.

CMG’s experts can design a protocol for your product to fit into one of our existing groups. This means we can save you up to 60% of the cost when compared to a stand alone protocol.

Stability of a medicinal product must be monitored in a continuous program in the retail packaging over the product shelf life. This is to determine that the product remains within specification under the labeled storage conditions until its use by date.

The minimum requirement is one batch per year of each formulation of product manufactured in every primary retail packaging configuration.

The testing criteria must be designed to detect stability issues such as active level deterioration, change in the levels of impurities and disintegration / dissolution profile changes. The raw data is required to be reviewed by a competent authority and summary and final reports made available to both the sponsor, manufacturer (where different), including the individual authorized to sign Release for Supply and the licensing authorities.

The principle of grouping like products together into a stability group is specifically noted in 6.29 of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products January 2009. This is in recognition of the reduced risk generally associated with complementary medicines. The bracketing of formulations within a stability group must be scientifically justified in terms of the same dosage form, similar formulation and similar packaging type to be considered acceptable as essentially similar products. Rotation of products and selection of products from several equivalent manufacturers within the justified group in the on-going stability program is also allowed with appropriate scientific justification.

 

Requirements

The on-going stability program must be described in a written protocol for each product allocated to the stability group based on the dosage form, formulation type and retail packaging as listed on the ARTG. The protocol must specify the parameters of the stability group.

Test methods used for the stability testing of products need to be validated as stability indicating, to a standard consistent with the TGA’s Finished Product (Medicine) Analytical Procedure Validation for Complementary Medicines.

Stability indicating HPLC methods for vitamins are required, with testing to be performed at each time interval

Where herbal ingredients are present, chromatographic profiling by HPLC or HPTLC must be included in the protocol. Comparison of the profile at each time interval will possibly indicate the presence of impurities or breakdown products.

The results of the on-going stability programme for each of the products within a scientifically justified stability group will be able to be applied to determine that the product remains within specification under the labeled storage conditions until its use by date as per the compliance obligation.

This requirement will allow several product improvements, such as adjustment of stability overage levels, reformulation of products to delete poorly performing actives or add other synergistic actives and improved active levels. Review of packaging types, specifically for export markets and where appropriate extension of shelf life claims will be able to be made.

For info on our stability Services This email address is being protected from spambots. You need JavaScript enabled to view it.

 

References

Technical Guidance on the Interpretation of Manufacturing Standards On Going Stability Testing for Listed Complementary Medicines June 2010

PIC/S Guide to Good Manufacturing Practice for Medicinal Products January 2009

Australian Regulatory Guidelines for Complementary Medicines

Finished Product (Medicine) Analytical Procedure Validation for Complementary Medicines March 2006

Therapeutic Goods order 78 Standard for Tablets and capsules

Therapeutic Goods Order 77 Microbiological Standard for Medicines