Stability Study Design
Stability testing is an essential component in evaluating the physical, chemical, biological, and microbiological properties of a product under varying storage conditions. These tests are crucial for determining the product’s shelf life, storage conditions, and for and for monitoring the quality of the drug. This is why the proper planning and execution of stability studies in accordance with regulatory requirements is a critical element in the development and control of medicinal products and active substances.
The stability testing process involves several stages:
- Planning and Study Design – At this stage, it is crucial to design the stability study carefully, considering its objectives (e.g., determining the expiration date, conducting on-going studies, stress testing), the product’s specifics, and all regulatory requirements (e.g., ICH, EMA, FDA guidelines). During the planning phase, the product’s composition, its pharmaceutical form (e.g., tablets, cream, solution for injection), potential factors affecting stability (temperature, humidity, light, preservative/antioxidant content), and the required shelf life are analysed. A stability study protocol is also developed, which includes the key parameters to be tested, the time points at which they will be evaluated, and the total time duration of the study.
- Sample Storage under Controlled Conditions – SPh will support during selecting the stability study conditions in which samples will be stored. SPh cooperate with numerous subcontractors, therefore we can help in selecting the appropriate laboratory specializing in stability testing of targeted medicinal product. Stability samples are placed in specific conditions corresponding to real-time, accelerated, and, if applicable, intermediate storage conditions. Accelerated testing conditions (higher temperature, increased humidity) help predict how the product will behave over an extended period. Additionally, the conditions under which stability studies are conducted are selected based on the target market, following the guidelines for ICH climate zones: for Zones I and II, as well as for Zones III and IV. All conditions are strictly monitored and controlled to ensure reproducibility of results.
- Scheduled Analyses – At specified intervals, sample analyses are conducted to evaluate key stability parameters such as appearance, pH, assay, impurities, and microbiological purity. We have experience in analyzing obtained results, including results outside specification/trend (OOS/OOT) or unexpected (OOE). The analysis allows monitoring of any changes that may indicate product degradation or deterioration of its quality. Based on these assessments, the expiry date is determined and appropriate storage conditions for the medicinal product are selected.
- Reporting Results – After completing each stability testing cycle, detailed reports are compiled, containing the analysis results of all tested parameters. These reports include a comprehensive summary of the results, interpretation of changes, and recommendations for further action with the product, such as extending the expiration date or adjusting storage conditions.
Benefit from our support
Our company has extensive experience in conducting stability studies for various types of medicinal products, and we have completed projects for leading pharmaceutical manufacturers. What sets us apart is:
- Expert Team – Specialists with extensive experience who are well-versed in the specifics of the market and regulatory requirements for various types of medicinal products.
- Personalized Approach – We provide tailored solutions for each client, customized to the needs of their products.
- Successes – We have a track record of successful projects with major corporations, enabling them to launch products of the highest quality.
- Ongoing Knowledge Enhancement – We continually expand our knowledge of current requirements and registration procedures through participation in both internal and external training.
Why SciencePharma?
Our experts will provide you with support in developing the most optimal stability study plan, tailored to both products and medicinal substances. SciencePharma offers a comprehensive process – from designing stability studies (including stress and photostability testing), through data analysis for validation batches during the development stage, to stability planning for commercial products. We can also focus on specific aspects of the process, such as designing specifications applicable until the end of the product’s shelf life and determining appropriate test limits.
Additionally, we offer assistance in resolving issues that may arise at any stage of the studies, such as deviations occurring during stability testing. Our support will help reduce the number of necessary tests and optimize the entire stability study process, saving time and resources while ensuring accuracy and regulatory compliance. Our specialists will also evaluate the stability study results and assist in determining the optimal shelf life of the product.
SciencePharma also offers support in the transfer of analytical methods and assistance in finding a suitable partner for stability studies.
Contact us
SciencePharma is an experienced partner in the stability testing process, providing comprehensive support at every stage – from design and analysis of the results to reporting. With our team of experts and personalized approach, we help our clients optimize the testing process by reducing the number of necessary tests, thereby shortening the implementation time and reducing costs. Partnering with us ensures regulatory compliance and confidence that your product meets the highest quality standards. Contact us to learn how we can support the development and stability of your products.