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:

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


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.
                                                                              Ketamine


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.

Monday, May 9, 2011

LABEL PRINTING - STABILITY TESTING FOR PHARMACEUTICAL INDUSTRIES

Labeling is an important aspect of stability studies in pharmaceutical industries. Labels are very useful from study login to print summary reports that can be submitted to drug enforcing agencies. With several products, studies, conditions, tests, protocols, intervals and inventories, stability labeling can be complicated. Drug enforcing authorities’ compliance makes proper labeling a more difficult process.

A stability software label system should accommodate all these scenarios. More and more information is needed on the label to get the required information on the drug during stability testing. Packaging materials are getting smaller and to label them with more information is getting tougher.

There are several types of methods to store information on labels:

Linear Barcode,
RFID and
Matrix Barcode are some of them.

Linear Barcode can store little information and sticking the label to small ampoule may not only be cumbersome but also very difficult to scan.

RFID is seen as the clear replacement to bar code since it is an order of magnitude and more productive such as allowing scans of thousands at a time. However FDA has not allowed RFID technology to be used for drugs covered under a Biologics License Application or protein drugs covered by a New Drug Application since the potential impact of radio frequency (RF) radiation on biologics and proteins.

A matrix code, also known as a 2D barcode or simply a 2D code, is a two-dimensional way of representing information. It is similar to a linear (1-dimensional) barcode, but has more data representation capability.

Among the above three, Matrix code would be the best choice with more information in small space.

A good labeling module of stability software should
• have a secure but user friendly and easy access for label design.
• manage variable data and should clear the data after it is printed. However it should allow the user to reprint the label with proper permission and logging the reprint operation to the log module.
• have proper edit logs and audit trials reports along with appropriate approvals.

EAPHARMICS eSTAR Stability Software Label Module:
Secure Login:
Manage Labels Options:
Label Manager: Labels can be designed with this option.
Label Request: Labels can be requested with this option.
Label Printing: Labels can be printed using this option.

Label Manager:

Various types of labels can be designed using EAPHARMICS eSTAR Stability software.
Fields available are displayed in the left hand side of the label manager. These fields are dynamic and are retrieved from the database. Several fields that are needed to design the fields can be stored and retrieved from the database.

Matrix – 2D Label:


The above image can contain lots of information for its size. Any 2D Bar code scanner can scan this image and retrieve the data into forms in EAPHARMICS eSTAR application and run readable reports. This barcode tractability is available throughout the EAPHARMICS eSTAR SOFTWARE application.
Several commercial 2D Bar code scanners are available to read these small labels with lots of information. These readers can increase productivity because of their omni-directional reading capability.
Label requests can be made by selecting the product and combining the required label with them. Additional labels can also be printed by entering the reason for additional labels.
After requesting the label, the labels can be printed from the label printing node. As soon as the labels are printed the data is cleared from the data grid. Additional labels can also be printed by following the same procedure and by inputting the reason for printing additional labels.

The reasons and logs can be viewed through access log (similar to the above report) or other log reports available in the EAPHARMICS eSTAR Stability Software.

EAPHARMICS eSTAR Stability Software has all these features that are necessary for pharmaceutical industries for stability testing:

• Secure Access
• Manage variable data
• Manage Label
Label Design
Label Request
Label Printing
• Ability to design and print 2D barcode labels
• Clear the label data after printing
• Log printing module access and printing process
• Ability to print extra labels with reason
• Run access and other log reports.

For more information about EAPHARMICS eSTAR Stability Software:
EAPHARMICS