Electronic Stability Testing Analyses & Reporting (eSTAR) by EAPHARMICS
New Study Login:
Information - Log in Drug Information - New Study
Stability Maintenance Modules:
Specifications:
Test Information - Along with Protocol and Intervals
Stress Testing - Temperature
- Humidity
- Photostability
Testing Frequency - Three points - 0, 3, 6 or Four points 0, 6, 9, 12 or Customized points
Storage conditions -Data Dictionary and select it in New Study Login
Batches -
Stability tests should be done at least on 3 batches
Data Dictionary
- Container Closure Systems along with all information
Stability Commitment:
Alerts are provided in the system, so stability tests are not missed.
Proper Stability Data is obtained and stored in the system
Evaluation - Data Analyses - Graph View, Upper Level, Lower Level, Linear regression
Label - More on Label Printing -
Label Printing
Stability Summary Final Report ready for submission to FDA:
More Information - www.eapharmics.com
Makesh Karuppiah, Ph.D
Senior Scientist
Stability Summary Final Report ready for submission to FDA:
RELIABLE SECURE & ACCURATE
Data maintained in ORACLE Database
Final Note: Stability testing should be done for all pharmaceutical ingredients,products and data should be readily available to regulatory authorities in all parts of the World with no exceptions.
Senior Scientist
