Stability Guideline for Stability testing fulfilled by Stability Software - EAPHARMICS eSTAR

Electronic Stability Testing Analyses & Reporting (eSTAR) by EAPHARMICS

Software Details
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:

RELIABLE SECURE & ACCURATE 

Data maintained in ORACLE Database 

More Information - www.eapharmics.com

www.eapharmics.com

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.

Makesh Karuppiah, Ph.D
Senior Scientist