In order to attain approval for new drugs, there must be a process of gathering pharmaceutical stability testing data in order to determine a comprehensive stability profile. The guidelines for this are laid out in ICH Q1A(R2), and this stability guidance is the governing standard for the regulatory bodies of Europe, the USA and Japan.
When assessing overall stability, testing must cover drug substances, drug products, all combination devices and any raw materials involved. To ensure the tests are accurate, there should be 24-hour monitoring and fail-safes in place to protect against power loss in the testing apparatus. Stability studies require the utmost attention to ensure the results are accepted for approval of the drug.
Storage conditions for ICH stability studies
The ICH stability storage guidelines define storage conditions and time periods for stability studies of long-term, intermediate and accelerated storage. The general ICH recommendations are as follows:
25°C/60% Relative Humidity (RH)
These ICH stability conditions are not comprehensive, and it may sometimes be necessary to provide custom storage conditions, particularly at freezing temperatures like -20°C and even -80°C. Refrigerated conditions may also be appropriate, which are defined as long-term storage between 2-8°C.
Analysis of ICH stability studies
There are many analytical techniques that might be required to assess the stability profile of pharmaceutical products. Common analytical techniques include High Performance Liquid Chromatography (HPLC), Liquid Chromatography-Mass Spectrometry (LC-MS) and Gas Chromatography (GC) testing. In most cases, samples are taken at predetermined points in time and are tested analytically to ensure the continued viability of the substance. For example, in a 24-month study, the samples will usually be tested at 1, 3, 6, 9, 12, 18 and 24 months.
Analytical analysis of samples isn’t the only thing that can be done. The samples can also be tested to measure sterility, package integrity, container closure integrity, levels of endotoxin and the bioburden on different products. It can be advantageous to collect as much stability data as possible when seeking approval for drugs, so consider working with laboratories who offer the full range of analysis through the testing process.
A necessary step
Stability data taken against ICH guidelines is a requirement if you are to gain approval for pharmaceuticals in any of the relevant regions. Long-term stability studies take a minimum of 24 months, so it is important for organisations to initiate the gathering of stability data as soon as a suitable drug candidate has been identified.
Once the storage stability testing has been completed, a comprehensive set of storage instructions can be created that is fully compliant with ICH storage guidelines. Specialist companies like Roylance Pharma offer pharmaceuticals storage that can meet the requirements defined in any ICH-compliant instructions, so once the storage needs have been assessed it will be important to work with the best storage provider. As you know, the safety and efficacy of pharmaceuticals are paramount, and the ICH guidelines are there to ensure there are consistent standards maintained across the territories it covers.