Stability studies span the entire product lifecycle, with lab teams conducting critical tests that determine product shelf life and storage conditions. In pre-commercial phases, stability studies are an important part of regulatory submissions, like an Investigational New Drug (IND) or New Drug Application (NDA). For post-commercial, it is a necessity to perform ongoing testing to monitor commercial batches and enable updates to the manufacturing process or packaging as needed based on test results.
Programs for stability testing are mandated in the U.S. by the FDA under 21 CFR Part 211.166. A part of Current Good Manufacturing Practice (cGMP), the regulation requires organizations to evaluate a drug or product’s characteristics over a period to confirm that it keeps its identity, strength, quality, and purity until its determined expiry date.
Similar requirements exist globally with a focus on maintaining the quality of products delivered to patients. Complying with regulatory guidance, like the ICH Q1A(R2) series, is key to achieving product acceptance overseas. Yet, stability study management is limited by the legacy systems and processes used to orchestrate workflows for compliance and conduct testing, often requiring manual intervention.
Addressing existing challenges in stability testing
Even with clear regulatory requirements, designing efficient and compliant stability programs continues to be an ongoing challenge for the industry. The traditional approach of manual stability study design, execution, and reporting can be inefficient and costly, increasing the risk of non-compliance. Additional challenges include:
Study management: Accurately tracking stability samples and ensuring efficient “pulls” for testing is a common shortcoming of legacy systems. Conducting via manual, paper-based processes or using fragmented systems limits transparency. This can contribute to delayed sample pulls, which may require investigation and could affect study acceptability or regulatory risk, depending on the protocol and circumstances
Analytics and reporting: Manual reconciliation across paper records and disconnected systems can increase the risk of transcription errors and make it more difficult to maintain data integrity. Developing a submission-ready stability timepoint summary becomes a tedious task for lab teams who need to track down and verify test results manually.
Trending and OOS investigations: Proactively flagging degradation issues is key, yet access to accurate data and built-in statistical tools limits trending. A disconnect across lab investigations and quality event management builds upon the ineffective processes, compounding challenges when issues arise.
Building a more connected stability testing process
An advanced LIMS can help standardize stability testing workflows used to establish product shelf life and storage conditions. Applications with Open APIs that can connect with quality management systems (QMS), enterprise resource planning (ERP), or electronic lab notebooks (ELNs) ensure data flows for real-time access to information. A clear change management plan is also critical to enable staff to adopt new ways of managing stability studies. When supported by effective integrations, change management, and digital data capture, a LIMS can reduce some of the manual work involved in preparing stability data for regulatory submissions.
Industry-standard stability study management can help staff to design, complete, and oversee product stability testing digitally. Key processes, like inventory and timepoint pull management, test assignment and execution, specification evaluation, multi-level review, and generation of timepoint and study summary reports are required for a complete solution. When evaluating stability capabilities within a LIMS application, consider a system that offers point-and-click configuration of stability studies for faster study design and paperless method execution for recording all attributes, inputs, and results.
Interested in lab tools and techniques?
Here are six other key considerations when evaluating the market for a new LIMS:
Assess which paper-based steps the system can replace or reduce: lab teams are accountable to ensure all production and quality control (QC) stages meet the requirements for a safe product release and product stability. Systems that require manual, paper-based processes often lack data visibility and status tracking across partner networks, increasing the risk of non-compliance and challenges during regulatory review. A LIMS with a more comprehensive digital experience can provide additional controls needed for regulatory readiness.
Review system architecture and domain: a LIMS can offer three different architectures, including a traditional on-premises LIMS, a traditional hosted LIMS, and a software-as-a-service (SaaS) LIMS. Traditional LIMS are implemented with on-premise hardware and often have a higher total cost of ownership (TCO) because of validation and infrastructure costs. An alternative is cloud-hosted on-premises, which offers a hybrid of on-premises hardware hosted by a vendor in a private cloud. A SaaS LIMS may offer advantages such as vendor-managed infrastructure and reduced internal hosting responsibilities, although suitability depends on the organization’s validation, security, integration, and governance requirements.
Pinpoint a competitive advantage: reducing lab cycle times can provide an edge so defining how LIMS can accelerate product time to market is key. For example, with automation and industry standard workflows for processes like stability studies, clinical stage companies can better manage data and documents to drive regulatory readiness.
Outline and track metrics: advanced features can provide faster return on investment, so defining and measuring value is a critical activity for new systems. Benefits realized with a new LIMS could include lower operational costs and implementation speed. Long-term advantages can be improved test accuracy and faster batch release timelines.
Define a resourcing strategy: to consider a new LIMS, secure a leader as an executive sponsor, build a team of process owners and subject-matter experts (SMEs), and design a change management plan for end-users. This team identifies necessary integrations with other applications and ensures key processes are evaluated as part of the implementation, all priority areas that define the long-term success of a new LIMS.
Embed processes: to drive user adoption of systems and new ways of working, update standard operating procedures (SOPs) and incorporate change management into implementation plans to limit lab disruptions.
Adopting a LIMS within a connected technology ecosystem and a comprehensive change management approach allows quality organizations to consolidate activities, reduce the manual processes typically associated with stability studies, and lower risk of human errors. Managing studies, reporting, and data trending on an advanced solution streamlines testing and analysis, empowering lab teams with the data and processes needed to meet changing regulatory requirements. These improvements may help organizations apply stability procedures more consistently and respond more effectively to changing regulatory expectations
