Friday, April 17, 2020

Eapharmics - Stability Software for Pharmaceuticals including Vaccines

Pharmaceutical Electronic Stability Testing Analysis and Reporting -
eSTAR - Manages Stability Testing, Data Analysis and Reporting

As various pharmaceutical companies with hard working scientists in various fields working towards finding a perfect vaccine for COVID-19, it is as important to study the stability of these vaccines to estimate the effectiveness of the available vaccine for the duration  of effectiveness, simultaneously.


Important aspects of Stability of Vaccines during all stages of  development and is easily recorded and analyzed in the 
EAPHARMICS eSTAR Pharmaceutical Stability Software.

From early stages of development to final stages of stability report, Stability is simplified in the eSTAR application with Secure, Reliable and Accurate Stability Software Application.

Key Aspects of Vaccine Stability:
Vaccine Stability study Design,
Vaccine Stability in different climate conditions:
Climate Zone I:

Climate Zone II:
Mediterranean, Subtropical

Climate Zone III:
Hot, Dry

Climate Zone IV:
Hot, Humid

Stability evaluation at different stages of production and use,
Stability indicating parameters,
Stability frequency testing,  
Cumulative age of an antigen and effectiveness of Vaccine,
Stability studies for clinical trial, 
Stability evaluation for during and after licensing,
Stability testing including assays for lot release,
Stability Test Results, 
Stability Data Analyses and Evaluation including Statistical Analysis,
Stability studies and analysis of the data to support manufacturing changes, and 

Data analysis Stability evaluation of combined vaccines.

Quality labeling is important for vaccine storing objects and should adhere to compliance authorities (Such as United States Food Drug Administration-USFDA, Therapeutic Products Programme-TPP, International Conference on Harmonisation-ICH, Therapeutic Goods Administration-TGA, National Institute of Health Sciences - NIHS and European Medicines Agency EMA of European Union EU and other agencies) requirements.

Important details including expiry date should be clearly detailed in the label. 

Sensitivity of vaccine to environmental factors (Light and Temperature effects) and recommended preventive measures details should be added in Labels.

EAPHARMICS also provides complete Data Governance and Regulatory Compliance  for Pharmaceutical Industry.

EAPHARMICS wishes all pharmaceutical companies to produce a speedy stable Vaccine against Covid-19 and provides support for the stability software needs for the vaccines.


Sunday, December 18, 2016

Stability Software

EAPHARMICS eSTAR - Stability Software - Easy stability data management.

Data security with power of Oracle Database.

Best Labeling for stability

Excellent Stability report.

Best electronic Stability Testing Analysis and Reporting.

Monday, November 17, 2014

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:


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:

Data maintained in ORACLE Database 

More Information -

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

Friday, August 31, 2012

Ketamine ScheduleIII Controlled Substance

Ketamine is a controlled substance. Specifically, it is a Schedule III substance under the Controlled Substances Act. Schedule III drugs, which include codeine and anabolic steroids, have less potential for abuse than Schedule I (heroin) or Schedule II (cocaine) drugs. However, abuse of Schedule III substances may lead to physical or psychological dependence on the drug.

Recently read about these Ketamine are produced without any accountability. Authorities have to strictly enforce accountability on these type problematic drugs. Each and every tablet should be accounted for, so that it does not spoil the life of young people all over the world. EAPHARMICS eSTAR stability program allows to account each and every unit of the drug at least in stability level. This should be taken into real world so that every tablet is accounted for and not end with a healthy individual.

There are so many side effects this Ketamine can cause. A careless person's greed will lead to health degradation of youth's health all over the world.

Thursday, December 15, 2011

Pharmaceutical Stability, Process against counterfeit drugs and relabeled expired drugs

Process against counterfeit drugs and relabeled expired drugs:
Day by day counterfeit drugs come into market.
Some of the expired drugs make back to the market after being relabeled with new expiry date.
These are worst criminal activity against human kind. Patients think they will be cured by taking the doctor prescribed drug, but instead of consuming regular medicine they may be consuming counterfeit or expired drug. This could lead to adverse effect and even to death.
Every government (especially the countries that have more percentage of counterfeit and relabeled expired drugs) should counteract against these counterfeit drugs and expired drug sales through their regulatory administrations. Each and every medicine in the market all over the globe should be traceable and if needed at a single tablet level.
How can this be achieved?

Every batch produced by pharmaceutical companies should have encoded unique id, batch number and expiry date. Some of the samples from every batch go through the stability tests which are periodically inspected by Federal governing agencies. Confirmation samples from every batch should be stored. Labels used in these samples should give all the information of the drug that is marketed and easily tracked. Each pharmaceutical company should have a system through which their drugs, batch number and expiry date can be verified by means of communication. At this communication age that should not be an issue and be easily achieved through databases and devices, cost effectively.
Every country should have proper Drug Administration Authorities and process in place. All the manufacturing pharmaceutical industries should perform stability tests and account for all the drugs they are manufacturing. Drug authorities should do regular and surprise audits to make sure the stability tests are properly conducted and confirmation samples are properly stored. Encoded labels should contain all the required information along with the unique id, drug name, batch number and expiry date. Drug Administration Authorities should also audit the retail stores regularly or surprisingly and perform drug information validation and confirmation with the drug manufacturer along with the expiry date. Also every drug consumer should have the ability to check with the manufacturer that the drug is a genuine drug. If any discrepancies are noted drug administration authorities should have authority to administer severe punishments to perpetrators, which will deter them to manufacture counterfeit and sell relabeled expired drugs. When every piece of drug manufactured is accounted for, it will become very difficult for manufacturing counterfeits and relabeled expired drugs to be let into the market.

Also this drug accountability will help in proper disposal of expired drug, which otherwise might enter the environment and cause potential damage.