What inspired this Wish List Request? Internal Release Limits (IRLs) is a standard practice in ensuring drug product quality within the pharmaceutical and biopharmaceutical industries. It highlights the necessity for precise calculation, application, and management of IRLs to guarantee that a batch of drug product remains within specifications throughout its shelf life. The current challenges include the complexity of calculating IRLs accurately, considering factors like product instability, measurement variation, and the incorporation of batch differences, alongside maintaining compliance with regulatory standards.
Please describe the new or improved feature or solution you would like to see.
Integrate an IRL calculation and reporting module (as a Red Triangle Menu item) within JMP > Analyze> Reliablity Survival> Degradation> Stability Test
This module would provide the following capabilities: Automated Calculation of IRLs: Incorporate statistical models and formulas directly allowing users to input critical quality attributes (CQAs) data and automatically calculate IRLs with precision, considering stability change, assay uncertainty, and batch variability - displays IRLs, external release limits, shelf-life specifications, and control chart limits for multiple batches.Automated generation of reports detailing IRL calculations, associated risks, and compliance documentation for regulatory purposes.
What would the value be to you and/or other users if this new feature is provided? Incorporating this feature would significantly improve efficiency, accuracy, and regulatory compliance in the management of drug product quality. By automating the calculation and management of IRLs, JMP users, particularly in the biologics and biopharmaceutical sectors, would save time and resources while minimizing the risk of non-compliance. Moreover, it enhances JMP's competitive edge by offering a unique toolset tailored to the intricate needs of these sectors.
Is this an external customer request? Biocon - A major player in the biopharmaceutical and biologics sector, expressing interest in the feature for its stability program. Rakesh Goud Vasker and Arnab Biswas
Is there a competitive software package that has this feature or solution that we should be aware of? SLIM, ASAPrime several LIMS packages have dedicated features for calculating and managing IRLs in compliance . By implementing this feature, JMP could fill a critical niche.
Will this impact a renewal, expansion, or adoption at a customer, and does this put an account at risk if we do not address this? For customers, particularly those in the biologics, biopharmaceutical field , the availability of this feature could be a decisive factor in choosing JMP over other software solutions.
