TGA Laboratories' role in an international program on the quality of anti-retroviral medicines
September 2007
The World Health Organization (WHO) had been running a Pilot Procurement Quality and Sourcing Project which assessed the acceptability in principle of HIV/AIDS drugs for purchase by UN agencies. However, a large number of problems and deficiencies in the quality of anti-retroviral medicines (ARVs) were identified during the operation of this program. To address this, the WHO approached the Therapeutic Goods Administration Laboratories (TGAL) to seek participation in a work program designed to provide quality control specifications for use by all WHO member states, particularly those in developing regions. The request recognised TGAL's capabilities and reputation in the area of pharmaceutical analysis. The WHO agreed to contribute to the cost of the project.
TGAL agreed to be one of 5 international laboratories involved in the program to develop robust test methods and specifications for the currently available ARV medicines. The work involved the development of validated analytical procedures for the active ingredients and their various dosage forms. These procedures were to be incorporated as monographs into the International Pharmacopoeia for use by countries that might not have the capacity to independently develop such quality control measures. Since the program commenced in 2004 TGAL has contributed to the development of monographs for 3 active pharmaceutical ingredients (lamivudine, stavudine and zidovudine) as well as monographs for various dosage forms containing these active ingredients. These monographs have been adopted for inclusion in the Fourth edition of the International Pharmacopoeia and will be published in the First Supplement.
TGAL recently recommitted itself to the program for 2007-2008. Collaborative work is currently underway on the development of further new monographs for the International Pharmacopoeia for Zidovudine tablets, Stavudine powder for oral solution, and fixed dose combinations of lamivudine + stavudine, lamivudine + stavudine + efavirenz, and lamivudine + stavudine + nevirapine.