The stability study is a critical part of pharmaceutical product development, to determine how quality is affected with time in different environmental conditions. The efficacy of stability testing relies on careful monitoring and documentation. Accuracy and precision are directly correlated with successful stability testing; the more data provided as part of stability testing, the more detailed the insights into long-term quality may be. If something were to go wrong, proper testing and documentation help pinpoint the source of the issue so that it may be adequately addressed.
Unfortunately, the implementation of stability testing widely varies across pharmaceutical companies.
Disparate Stability Study Systems
The current old-school system for managing stability testing uses Excel spreadsheets to record data for different samples across various time points. This system of data management rapidly becomes overwhelming, which leads to inconsistency, errors, and inaccuracy—all of which are extremely problematic for long-term results.
Not having an effective database management system for stability planning and scheduling creates problems across all real-life use cases. Although spreadsheet documentation seems simple enough when initially deployed, even the smallest company will outgrow this form of data management. What may work for one or two products simply isn't sufficient for twenty simultaneous studies. Even the planning around stability testing—having the appropriate materials on hand, ensuring the correct frequency of testing, etc.—is difficult with Excel spreadsheets.
Risks of A Weak Stability Study Program
Accountability in performing regular stability testing is essential, or else laboratories and businesses will be exposed to high risk for failed products, penalties, and even potential shutdowns depending on the severity of any problems that may ensue.
A major issue that may result is the potential failure to adhere to study protocol. The inability to follow a plan required by regulators for product approval can be extremely costly, as can the inability to prove that the plan was adhered to during product development and production. If stability testing cannot be controlled and demonstrated, then product approval may be revoked or not granted in the first place. And given that a single stability study lasts an average of between three to five years, the time loss in the event of product rejection is highly significant.
Not being able to track any changes from the plan is just as much of an issue. Some deviations from the plan might be valid, but laboratories must be able to produce accurate records of what exactly happened in order to justify the final product. Documentation can also illuminate any potential effects of any actions on product stability, including late pulls, additional testing, less testing, changing specifications, and other protocol changes.
Cheaper Alternatives Aren't Sufficient
There are myriad alternatives to which laboratories may turn to meet their stability testing needs, including spreadsheets, paper documents, databases, bespoke proprietary software, and other creative alternatives. Usually, the primary motivator behind the use of these alternatives is to keep costs low. And because these solutions only address stability testing, these facilities usually have other separate solutions to address other laboratory issues such as inventory management.
The reality is that any perceived cost savings are only applicable in the short-term. In the long run, cheaper alternatives drive up costs because they only address part of an overall process and are incomplete solutions often resulting in audit failures or issues during product approval.
Implementing a combination of disparate systems makes it very difficult for anyone to know where something is or what the status is across samples; only single, isolated data points are available, in contrast to a LIMS implementation where the entire sample journey is readily available and controlled from beginning to end. And as a company grows, its data management demands invariably increase; having multiple systems to manage the testing, inventory, and data is a mammoth risk.
Why Implement an Enterprise Stability System?
A trusted LIMS not only offsets the burden of testing and documentation, but they also increase the capability for more detailed data collection and analysis.
Ideally, a laboratory does not want simply a static system that simply documents the process. Preferably, the laboratory has a system that is proactive, capable of managing it and informing it of what actions are necessary—and when. Ideally, this system can flag upcoming stability study events and note any upcoming or required sample pulls. This reduces the potential impact of individual error, improves resource forecasting, and makes it easier to effectively manage testing and documentation.
A LIMS also serves as a central repository for all sample data. By having all of this data centrally stored in one place, any authorized member of the laboratory can gain instant access and control over the entire stability study. This adds an extra level of data security, and protects the integrity of any stability study findings.
The plan must be entered upfront into the LIMS, which ensures that all information is collected. The sample volumes needed for stability study testing are input into a validated LIMS, and it takes the legwork out of ensuring that the right number of samples are readily available for testing. The LIMS makes sure that all samples are stored under the correct conditions; in the case of an emergency, it can document the duration of any deviation events that occur.
The LIMS also certifies testing execution, providing visible outcomes as required by the stability study over time. Because of the reliable collection of data, it is possible to do more accurate shelf-life predictions, witness sample trends over time, examine setting specifications, and even calculate specifications as part of regulatory submissions. When regulators stop by and ask laboratories how they justify their shelf-life calculations, a robust LIMS ensures that every piece of data is readily available.
A LIMS also maintains the chain of custody for every sample. Each individual sample carries total historical coverage, from creation of the study through receipt for testing, review, and even sample destruction. This reinforces adherence to protocol and best practices, and then furthermore documents this adherence.
If an out-of-box LIMS implementation is used, it is possible that these controls, traceability, and accessibility will already be in place, allowing a laboratory to rapidly gain the significant benefits delivered by such a system.
Replacing the three disparate systems of testing, inventory, and planning with one LIMS implementation makes sense from every aspect of laboratory resource management. Reduce human resource constraints, save time and money, and facilitate compliance by leveraging the large-scale automation capacities of a LIMS across documentation, storage, and testing. Support the validity of each stability study, even in the eyes of the strictest reviewer, by maximizing the accuracy and thoroughness of its testing regimen.