Stability studies are of the utmost importance for numerous branches of production, especially for the pharmaceutical and cosmetics industries. They provide evidence on how the quality of an active ingredient or a drug change over time under the influence of a variety of environmental factors such as temperature, humidity and light. Above all, they contribute to determine the period of time during which a product remains stable under the recommended conditions without compromising its integrity.
Therefore, these studies are usually programmed so that the analyses are carried out monthly in the first year and extend over 3 to 5 years.
For ongoing studies, samples may be tested at 6-month intervals to confirm provisional shelf-life, or every 12 months for well-established products. However, products containing less stable active ingredients should be tested every 3 months in the first year, every 6 months in the second year and then annually.
The test results are considered positive if neither significant degradation nor changes in the physical, chemical and, if relevant, biological and microbiological properties of the product have been detected and the product remains within its specification.
The Critical Timing of Stability Studies
Each scheduled time point of stability studies protocols is associated with strict time windows for pulling the samples, executing a battery of analytical tests and elaborate the final report
Each of these time points triggers a cascade of strictly regulated activities
- Sample pull from specific storage conditions.
- Analytical testing, which may require a wide range of expertise and instrumentation for physical, chemical, biological and/or microbiological techniques.
- Execution of tests, either in series or in parallel, depending on method requirements and equipment availability.
- Peer review of all analytical data and documentation.
- Preparation of a final GMP report for regulatory submission or for internal quality assurance.
Coordinating these steps across multiple departments, instruments, analysts and timelines requires a solution that can handle both the granularity and scalability of such operations.
Without integrated planning, these steps are prone to inefficiencies such as resource conflicts, idle time, missed timings due to repeats or experiments failure.
Optima: A Smart Solution for Stability Studies Scheduling
Optima Laboratory Resource Scheduling Solution offers a robust framework to address the operational challenges of pharmaceutical stability studies:
Streamlined Sample Pull Coordination
Optima schedules and alerts laboratory staff to upcoming sample pulls based on predefined stability protocols. It can:
- Notify the responsible personnel and link the action to subsequent analytical tasks.
- Track the status of each individual task and the entire project
Efficient Resource Allocation
Stability studies require a wide range of instruments and qualified analysts. Optima supports laboratories:
- Assign tests to qualified analysts with appropriate training and availability.
- Plan instrument usage to avoid bottlenecks, especially for high demand instruments.
- Adapt the duration of tests to the number of samples to be analysed.
- Plan work in advance while allowing for real-time changes, such as equipment downtime or staff absences.
Support for Sequential and Parallel Testing
Procedures often have to be performed in a certain order, while others are independant and can be performed simultaneously. Optima makes this easier:
- Workflows for parallel and sequential testing activities.
- Manages dependencies between tasks to ensure the correct execution order.
- Avoids idle time by distributing workloads across parallel streams.
Integration of peer reviews within GMP framework
The results of the individual analytical tests must be monitored by a second person. In addition, a QA team member may also need to discuss the final results or deviations with the analyst who performed the test. Optima features makes this possible:
- Integrates the peer review steps directly into the workflow.
- Assigns reviewers based on workload, availability and qualification.
- Ensure availability of the analyst for QA reviews
- Tracks review status and flags overdue actions to ensure timely documentation
Long-Term Planning and Recurrence Management
In contrast to one-off studies, stability programmes require recurring events at precise intervals over several years. Optima’s long-term planning function facilitates this:
- Automatic setup of recurring tasks
- No time point is missed during a multi-year study
- Easy adaptation to staggered batches and variable product matrices
In an industry where timing, accuracy and compliance are paramount, the Optima Laboratory Resource Management Solution empowers pharmaceutical laboratories, biotech companies, CMC analytical services and CDMOs.
It supports laboratories in performing stability studies with unrivalled efficiency and precision. From initial sample pull to final GMP reporting— across multiple storage conditions and time points — Optima transforms complexity into clarity, allowing scientists to focus on the science, not the scheduling of the activities.
By integrating intelligent planning, real-time adjustments and regulatory workflows, Optima is an indispensable tool for any laboratory committed to stability studies excellence.
