Sample stability is the ability of a component or product to retain its initial properties for a specified time when stored under specified conditions. Labs complete stability testing to calculate the extent to which a product degrades, identify the timing and type of impurities that appear, and determine how storage conditions affect stability. A LIMS Stability Solution is a more efficient way to setup and execute stability studies!
To meet regulatory requirements, labs must be able to assess stability accurately and verify stability testing results. This isn’t done at a moment in time. A successful stability program must be implemented prior to initiating a study, requires careful sample management throughout the study, and encompasses detailed reporting of results. A Stability Solution can improve efficiency and compliance for sample creation, sample custody, task management, scheduling, generating/recording/reviewing results, and reporting.
If successful, stability testing is a study-long process rather than an after-the-fact event (and it is), the questions each lab must answer are:
First, a sound stability testing system–like that afforded by a LIMS–provides you with control over the study as a whole. Overall control of the study is essential to ensure accuracy over time–of the product and of the processes. As the testing continues, your lab will look more and more to your LIMS as a repository of all study-related data, including storage parameters and details.
Secondly, a comprehensive stability solution gives excellent control over each sample. Sampling procedures can be precisely documented and tracked. Sampling analysis is precise and faster. Sample reconciliation is also quicker and easier since all the details of each sample are recorded.
A study with built-in system control and sample management is on solid footing for stability testing that’s successful.
According to an ECA Academy article posted in May 2020, FDA warning letters to drug labs contained “complaints regarding inadequate stability testing . . . in about every fifth Warning Letter in the fiscal years 2016, 2018, and 2019. This trend seems to continue for 2020, as three of the Warning Letters posted in January 2020 also deal with this problem.” This trend is alarming in an industry pursuing life-saving drugs and spending billions of dollars on product development. For example, in March 2020, the JAMA Network noted that “After accounting for the costs of failed trials, the median capitalized research and development investment to bring a new drug to market was estimated at $985.3 million.”
Warning letters, fines, and other penalties due to lack of compliance result in products being delayed in getting to the market. Some products fail. Some labs receive repeated penalties and eventually close. Some of the delay and expense associated with the pharmaceutical industry relates directly to the lack of a quality stability testing system.
Yes, this is counterintuitive, but it’s true. Labs that invest in making sure they can provide accurate stability testing reap cost savings in the long term. Part of the savings comes from decreased work hours resulting from increased efficiencies. Machine-based calculations and analyses are faster and more accurate. The benefits of efficiency compound as your lab grows, too.
Additional cost savings arise because fewer products are delayed or stalled from entering the market. Labs using dynamic LIMS will also be more likely to meet stability testing protocol and less apt to be fined.
SciCord lays the groundwork for successful stability testing by setting the parameters before a study begins, defining the protocol, and including appropriate personnel and reviews at each stage of the project.
When it’s time to perform stability testing, the SciCord ELN/LIMS provides functionality to manage every aspect of the stability sample management, define, document, and review testing related to each sample, and present accurate, detailed results in an attractive and easy-to-understand format.
Capabilities of the SciCord stability system include:
The SciCord ELN/LIMS also complies fully with the United States Code of Federal Regulations (CFR) Part 11 as it applies to a pharmaceutical lab that produces and utilizes electronic documents and signatures. To ensure compliance, SciCord provides a comprehensive set of roles predefined with permissions. Records are easily traced to the person who collected the data, the place of origin, and the time of data collection. Unique electronic signatures identify individuals who create or modify the electronic records. An audit trail includes the author or modifier of the data, the timestamp of the original and modified data, and the location of the data within the system.
Labs performing stability can benefit by deploying a LIMS stability solution providing management for all of the lab’s stability studies–big or small. Successful product stability studies begin with procedures and controls that are put in place before the project begins. A dynamic, integrated LIMS provides the framework to carefully monitor every aspect of sampling, help your lab meet all regulatory and compliance issues, and adhere to the time, storage, and value parameters set in place.
The SciCord ELN/LIMS combines all the functionality of a robust LIMS with the day-to-day flexibility of an ELN. It’s the perfect tool to guide your lab successfully through an entire product development project, including a requisite stability testing regime.
SciCord is a hybrid ELN/LIMS, featuring a spreadsheet paradigm, that combines the compliance and structured aspects of a Laboratory Information Management System (LIMS) with the flexibility of an Electronic Laboratory Notebook (ELN). The ELN and LIMS functions integrate seamlessly and enable your company to quickly reap the benefits of enhanced data and time efficiencies as you continue to meet compliance standards and follow GLP.
If you’d like to learn more about how you could use SciCord ELN/LIMS in your laboratory, please request a demo. Provide us your contact information, and we’ll share a helpful demo that will show you how our ELN/LIMS could boost the productivity of your lab and enhance the quality of your data.