Stability testing

October 8, 2010

THE TGA has released a new guide titled ‘Technical Guidance on the Interpretation of Manufacturing Standards’. Although not legally enforceable the new document provides guidance for the interpretation of the TGAs ‘PIC/S Guide to Good Manufacturing Practice for Medicinal Products 2009’ in relation to on-going stability testing for Listed Complementary Medicines. The document states that one batch of a complementary (listed) product of each group should be placed on the on-going stability program each year, and ongoing stability testing should be conducted in line with the regulatory guidelines for the countries of destination. The guide also states that stability testing should be conducted in real time at the storage conditions specified on the product label. For details see www.tga.gov.au.

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Pharmacy Daily | Stability testing

Stability testing

Other recent headlines

PD breaking news – Pharmacists to administer NIP vaccinations in aged care

PD breaking news – Top Western Australian talent honoured

Legal action for Montu

SEARCH PHARMACY DAILY

Featured video

Recent issues

INDUSTRY JOB VACANCIES