TRANSFORM THE MANAGEMENT OF DRUG STABILITY DATA
Drug stability (DS) testing provides evidence on drug substance and/or drug product quality as it interacts with environmental factors such as light, humidity, and temperature. As such, pharmaceutical companies must develop DS reports both during development and annual product monitoring to ensure continued safety and effectiveness. Pharma companies can generate thousands of DS reports a year, and even a single report can be comprised of many thousands of data points.
Factors that Impact Drug Stability Report Quality
For new drug development, annual monitoring, and/or the release of new drug products with the same drug substance or new packaging, DS studies must be completed and compiled into submission-ready reports. Transcribing study results into reports requires assuring data integrity and consistency of documentation. Errors in reporting data can lead to issues that could seriously compromise safety and effectiveness, and delayed or rejected submissions can result in time and resources lost while the drug is not marketed.
As drug development projects mature and annual monitoring continues, more data points must be aggregated and assembled into DS reports. Processes for handling all this data must be well managed. The greater the volume of data grows, the more error-prone manual DS reporting becomes. Any changes made to the drug product, packaging, etc. will also affect the scope and scale of DS reporting. Managing DS reports manually also takes up considerable amounts of time as the project scale increases.
Many pharma organizations invest heavily in DS testing, but often leave reporting as an afterthought. Much of this work initiated after the fact is done manually with Excel and Word. As the scale of DS reporting grows—as new drugs are developed and continuously monitored—this manual reporting process takes more time and resources to complete. Issues due to inaccuracies and noncompliance could draw significant resources and time away from regular reporting activities and have adverse impacts over the long term.
LEVERAGE COCKPIT FOR DRUG STABILITY
Turn your manual drug stability data reporting into a dynamic, compliance-ready framework for pharmaceutical product development. Regulatory and standards requirements pharma companies must align their DS reports with include:
- ICH Q1A(R2) - Stability Testing in New Drugs and Products
- ICH Q1E – Evaluation of Stability Data
- 21 CFR Part 211.166 – Stability Testing
- 21 CFR Part 211 Subpart J – Records and Reports
Generate compliance-ready Development Drug Stability reports for use in both new drug development and annual monitoring activities. Manage routine, postmarket reporting data throughout the drug lifecycle with Monitoring Drug Stability Reports.
REDUCE TIME, IMPROVE ACCURACY, AND REDUCE COST
Import from LIMS or Excel directly into Cockpit; automated rules check for errors and consistency.
Automatically aggregate DS data from all sources into a report template.
Automate rules for SOPs and WIs to populate report templates.
Create, review, generate, and export reports to PDF with consistent formatting, layout, font, etc.