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COMPLETE SOLUTIONS FOR PHARMACEUTICAL STABILITY PROGRAMS
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Pharmaceutical Stability Program
for Active Pharmaceutical Ingredients
and Drug Products
•
The purpose of stability testing is to provide evidence on how the quality of a drug
substance or drug product varies with time under the influence of a variety of
environmental factors, such as temperature, humidity, light and to establish a retest
period for the drug substance or a shelf life for the drug product and recommend
storage conditions.
•
Stability testing permits the establishment of recommended storage conditions,
retest periods, and shelf-lives.
•
Stability study’s role - From Investigation of New molecule Development (IND) to
post market products.
•
Stability Program Design & Role of eSTAR in stability studies.
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Drug Development Process
REVIEW AND
APPROVAL BY
REGULATORY
AGENCY
PHASE IV -ADDITIONAL POSTMARKET TESTING REQUIRED
•
w
NDA FILING
PHASE I TRIALS
PHASE II TRIALS
PHASE III TRIALS
IND FILING
PRECLINICAL STUDY
NEW MOLECULE DISCOVERY
DRUG SUBSTANCE STABILITY / PROCESS IMPURITY CONTROLS
DRUG SUBSTANCE AND EXCEPIENTS COMPACTABILITY
DRUG PRODUCT STABILITY
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Critical Role of Drug Stability
• Quality must be established for identity, strength, quality and purity (CFR
211.137) to assure Safety and Efficacy of drug product during its shelf life
when stored under the intended labeled condition.
•
Safety and Efficacy of drug product are established during drug
development via clinical studies (phase I, phase II and Phase III)
•
Change in Drug Products would risk safety of patients ( potential
- sub-potent or over-dose products,
- unknown toxic impurities,
- new degradants of unknown toxicity )
• Stability failure
Product Investigation
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Product Recalls
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Role of eSTAR in Stability Program
EAPHARMICS eSTAR stability software is a rich web based application integrated
with oracle database to monitor all type of pharmaceutical (including controlled
drug substances and biological products ) stability programs.
EAPHARMICS eSTAR is exceptionally suitable software for international
regulatory guidelines 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 guidelines.
eSTAR is designed for pre-clinical, R&D and Post market for Innovator/Generic
pharmaceutical companies throughout the world by the following interactive,
efficient and user friendly modules.
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eSTAR – Interactive Modular Design
Web based application allows controlled access from any site around the world.
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Part 11 Compliance Settings
The application
parameters will
define the
overall settings
for Part 11
compliance.
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User Settings
The user definition
allows limited
access to only those
with active
credentials. Web
access with rigid
controls.
Location based
users for Enterprise
solutions.
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Grant Access
User access is
further limited
by granting
access to
specific
functionality
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Tree Navigation
Program functionality is easily
accessed by use of the program tree
which is always displayed on the left
side of the screen. Select the
function to access and display
information for entry, editing, or
viewing/printing.
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Icons to Access Functionalities
Select the item
from the tree to
display the
entries.
Use the icons to add, edit, delete, or sort the
entries.
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Stability Dictionaries
Specification
Library
Analyst
Dictionary
Reason for
Study
Dictionary
User Defined
Fields
Dictionary
System
Dictionaries
Study
Conditions
Dictionary
Packaging
Dictionary
Abbreviations
Dictionary
Site
Dictionary
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Specifications Management
Product
Specifications
Library
Product
Specification
Protocol
Design
Standard Sample
Inventory Design
Multiple Protocols
Product Information
Individual Test Specification
Formula Information
Specification Option
Setup – CRT
Control Room Temperature
ACC – Accelerated
Controlled Temperature
Intermediate Setup
Sample Traceability
up to Interval Level
Label Control
Designs – Bracketing &
Matrixing
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Define Testing Matrix for Condition
Standard
Inventory for Testing Matrix
• Define
Unlimited
# of Matrices
•
“Click”
in
required
inventory
during study login
• Define in Months, Weeks
or Days
Use the specification library to
define your product line.
- Add new products
Define Required Tests
- Edit existing products
•Unlimited # of tests
• Value
or text limits
- Templates to generate similar
products
Define the product details
• Precision
• Lab Location
• Alert Limits
• Variance Limits
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Study Login
New Study Login
Information:
• Product
• Manufacturing
• Package
• Site
• Stability
Raw Materials
API Information
API Manufacturing
API Number
Study Condition, Tests &
Intervals
Study Condition &
Protocol Design
Normal / Challenge
Standard / User Defined
Study Intervals
Protocol type, Study Period,
Label Requirement, Storage
Condition, Study Sample Inventory,
Study ID Creation
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New Study Login
New study login is
made simple with
the use of the
Application
Dictionaries and
Libraries or import
from other
applications such
as SAP, LIMS etc.
Customizable
“User Defined”
fields.
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New Study Login – Raw Materials
Track all raw
materials and
suppliers
Tabbed user interface for
Study Login,
Raw materials
Study Conditions, Test Intervals and Inventory
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Study Login – Study, Test and Intervals
User
friendly
study
particulars
entry form
• Have the pull dates
automatically calculated or
• Enter them manually if needed
• Use dictionaries to “click” in
the information
• Study condition
Additionally:
• Assign the test matrix
• Make label requests
• Add comments
• Study login approval
prior to activation
• Reason for study
• Study Length
• To mention a few ...
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Customizable Labeling System with
Bar Code
Product Name:
•
•
•
•
•
•
•
•
•
ID:
Specification:
Batch:
Date:
Fill:
Container:
Condition:
Interval:
Due Date:
2D Bar Code Capabilities
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Label Design
Select fields that needs to be in the label
and design the label
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Label Printing
Different Types of
Labels can be
Designed and
Printed
( Including
2D Bar Code
Labels )
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Log Sample Manipulation
Interactive
operations from
Scheduling to Test
Completion
Color coded
indication of
Schedule Statuses
with explanation
Multiple Reports
Options for
Selected or All
Studies
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Data Entry Modules
• Layered Approvals for Data Entry.
• Controlled Substances inventory tracking.
• Sample destruction information reporting tools.
(DEA Form)
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Data Evaluation Modules
Parameter selection criteria to generate
interactive stability data evaluation graphs
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Graphics Modules
Interactive Graphs for
Data Evaluations:
 Single Product
 Multiple Product
 Sample to Sample
 Parameter Overlay
 Expiration Single Study
 Expiration Multiple
Studies
 Arrhenius plot
 Plus Data Export
Function
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Stability Summary Reports
• Use the bar code to activate any
functionality for the study.
• With the reporting tools, customize
the report header information.
Highlight out of spec
data if desired
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Easy Report Generation
Click the report icon
to instantly generate
any report.
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Water Marked Reports
Additional Report Formats:
• Include date for each test.
• Include analyst name for each test.
• Include reference information for each test
Water Marks on
request
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Interactive Help System &
24/7 eTicket For Immediate Attention
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eSTAR’s Capability in Stability Testing
Risk-based global stability protocols
Bracketing & Matrixing Designs
Various types of Stability reports
Various types of stability data:
- single result such as assay, loss on drying, etc.
- multiple results such as dissolution testing
- degradation product data
Different Types of Evaluations:
- Best Case
- Out-of-trend (OoT) results
- Change with Time
- ICH-Q1E Evaluation for Stability Data
- Drug stability
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EAPHARMICS eSTAR
SECURE, ACCURATE & RELIABLE
•
System built with powerful Oracle RDBMS database and Rich Internet
Application Adobe Technologies
•
Built by team with many years of Oracle, Stability and Scientific experience.
•
Easy to use stability system screens developed using latest technology
•
High level Security and Audit integrated stability system
•
SAP/3, BAR Code Smart Lab Interfaces ( Valquest / Trackwise / Documentum /
LIMS )
•
Document Attachments (OOS/OOT/Dev), Electronic Signatures, Custom Report
Formats and Audit Trail
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Advantages of using eSTAR for
Stability Testing
• Cost benefits by saving time and money.
• Easy customization of Application including interoperability and interaction with
existing software.
• Rich Internet Application Interface.
• Application in production environment from day one.
• Customer support is easily available.
• FDA requirements can be easily met as EAPHARMICS has a team dedicated only
for Stability Software and available 24/7.
• High availability, Security, Scalability, Performance, Manageability, Support for
large volumes of data are some of the features of EAPharMiCS Stability Software.
• Easy Migration of existing Data and interaction with existing systems.
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Contact
Website: www.eapharmics.com
USA
New Jersey
EAPHARMICS
1113 Old Freehold Road
Toms River, NJ 08753
Phone/Fax (732) 244-6694
Florida
EAPHARMICS
6121 Froggatt Street
Orlando, FL 32835
Phone/Fax (407) 578-2007
INDIA
EAPHARMICS INDIA
11 Sudarshan Nagar
Pollachi 642002, TamilNadu, India
Phone 95855 15269
www.eapharmics.com
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