Stability Testing is mandatory procedure for pharmaceutical products, as it provides evidence of how the quality of an Active Pharmaceutical Ingredient or Finished Pharmaceutical Product varies with time, under the influence of a variety of environmental factors such as temperature, humidity, and light. But, is your SOP tuned to address all details, in a fashion that correct work is ensured? Read more about this, in the RC REDOL article below, and find out!
Quality of Active Pharmaceutical Ingredients (API) or Finished Pharmaceutical Products (FPP), can be influenced by the environment, as we saw before, which is by itself a good reason to conduct Stability Testing. Nevertheless, other factors weigh in and, as such, Stability Testing programs should also include the study of product-related factors that influence its quality. For example, the interaction of the API with excipients, container-closure systems, and packaging materials and, in fixed-dose combination FPPs, the interaction between two or more APIs also must be considered. Furthermore, Stability Testing results are what make it possible to establish retest periods for the APIs (or shelf time for unstable APIs, in exceptional cases), as well as shelf life for FPPs and also the recommendation of storage periods.
As for procedures, in general, an API should be evaluated under storage conditions, taking into account the appropriate tolerances. Here, thermal stability and, if applicable, sensitivity to moisture, are tested. Also, the storage conditions and the length of studies chosen should be sufficient to cover storage and shipment. Furthermore, it shouldn’t be forgotten that storage condition tolerances are defined as the acceptable variations in temperature and relative humidity of storage facilities for stability studies. Therefore, the equipment used should be capable of controlling the storage conditions within the ranges defined.
Finally, APIs and FPPs should be tested in a stress testing fashion, as this can help identify the likely degradation of products and, in turn, help to establish the degradation pathways and intrinsic stability of the molecule. These assessments are vital to validate the stability-indicating power of the analytical procedures used and, as such, the nature of the stress testing will depend on the individual API and the type of FPP involved.
As you can see, Stability Testing is a vital part of the Quality Systems in Pharmaceutical and Life Sciences product manufacturing, and it can be sometimes overwhelming to decide on the best course of action to avoid incidents, recalls or sanctions by the authorities. RC REDOL can be your partner in that journey, as we provide your organization the experience and know-how needed to keep up to date with regulations and ensure correct Quality Management. Contact us to discover how we can help you!
RC REDOL, building connections!