It is a time-consuming process to manufacture a new medicinal product and place it on the market. According to the Pharmaceutical Law Act of 2 September 2011, that is in force in Poland, a medicinal product may only be placed on the market once tests have been run and complete documentation has been presented to the relevant authorities. One of the key tests that must be performed is the drug stability test which is run once the formula and composition of the product have been developed and once its physical and chemical parameters have been tested.
In order to ensure comprehensive product service, we run shelf-life tests of products conditioned in climate boxes:
- long-term (25˚C/60%RH),
- medium-term (30˚C/65%RH)
- accelerated (40˚C/75%RH)
Stability tests are run based on ICH guidelines (Q1A-Q1F), Annex 2, published by WHO
Drug stability tests – why are they so important?
Drug stability tests are obligatory tests before a medicinal product is placed on the pharmaceutical market. The basic objective of such tests is to determine the expiry date, as well as the effectiveness and safety of a medicinal product throughout its shelf life. Stability tests consist e.g., in checking the properties and activity of the active substance which is the main ingredient of a given medication. At a later stage, once the medication is already produced, its shelf life is checked.
The course of a stability test depends on the active substance used in a given drug product. During the test, it is taken into account what sort of transformations it may be subject to.
The course of drug stability test
When running drug stability tests, international ICH “Stability” Q1A-Q1F guidelines must be followed; the said guidelines strictly determine the scope of tests as regards:
- the selection and number of lots,
- rules of acceptance,
- the frequency of tests,
- analytical methods,
According to guidelines, the stability test must be run for at least three lots of a medication in its final commercial packaging with labels. After the test, the following steps must be taken:
- organoleptic evaluation must be done,
- physical and chemical properties must be determined,
- microbiological purity must be assessed.
Types of drug stability tests
Taking into account air temperature and humidity, drug stability tests may be divided into three basic types:
- Long-term tests which are run for a specified shelf-life period in conditions recommended in the leaflet and product label.
- Accelerated tests which consist in the medication being subject to chemical reactions and various temperatures and humidity of air. The objective of such a test is to check stability if the medication is stored not in conformity with the manufacturer’s recommendations (e.g., to verify whether its properties have changed completely during transport).
- Medium-term tests which are run at the temperature of 30 degrees Celsius and air humidity of 65% RH.
Curtis Health Caps specializes in comprehensive contract-based production of medicinal products. Our offer comprises also the stability tests of medicinal products and assistance in placing the products on the market.