Stability testing protocols for recorded and complementary Medications are manufactured in Australia by the Therapeutic Goods Administration TGA for many medications to be used within Australia. It applies to complementary medicines and sunscreens. Stability testing is used to test the long-term stability and quality of a therapeutic product under different temperature, humidity and light conditions. These tests are best performed in stability cabinets and photostability cabinets chambers such as those made by Weiss Technik and distributed in Australia and New Zealand by SimTech.Stability studies need to be performed in accordance with a Predetermined protocol, which is in accordance with ICH Guidelines for stability testing. Stability testing is continuing to ensure that the product remains stable within its shelf life.Stability studies need to examine relevant physical, chemical, And microbiological features of the item.
To establish shelf life under ambient lighting conditions the Samples may be exposed to exact doses of UV and visible light in a specially designed room like the Pharma Event Photostability Chamber. ICH Q1B stipulates that temperature should be controlled to prevent local hot spots.The Australian Government’s Department of Health Therapeutic Goods Administration bases its Stability Testing protocols around the ICH, International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use guidelines. ICH Q1A stipulates that through a stability test the conditions will remain constant ±2°C and ± 5%RH. Additionally, if these conditions aren’t met for over 24 hours the test might need to be lengthened, incurring substantial administration work.
While many stability chambers producers may assert, they meet These performance requirements frequently this isn’t the case and they could simply be quoting the truth of the individual sensor used for the dimension in perfect conditions. The measurement and control of relative humidity is quite sensitive to temperature and all hygrometers relative humidity detectors have a level of temperature dependence. Usually, a +/- 1 dig C temperature doubt will present a +/- 6% uncertainty in relative humidity. Therefore, Weiss Technik has spent substantial time and expense developing equilibrium chambers that achieve the maximum degree of accuracy for temperature and relative humidity both in time and in homogeneity in the test space.