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eapharmics

COMPLETE SOLUTIONS FOR PHARMACEUTICAL STABILITY PROGRAMS. “Click” for next slide. www.eapharmics.com. Pharmaceutical Stability Program for Active Pharmaceutical Ingredients and Drug Products.

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  1. COMPLETE SOLUTIONS FOR PHARMACEUTICAL STABILITY PROGRAMS “Click” for next slide www.eapharmics.com

  2. Pharmaceutical Stability Programfor 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. “Click” for next slide www.eapharmics.com

  3. Drug Development Process REVIEW AND APPROVAL BY REGULATORY AGENCY • w PHASE IV -ADDITIONAL POSTMARKET TESTING REQUIRED NDA FILING FDA PHASE I TRIALS PHASE II TRIALS PHASE III TRIALS IND FILING DRUG SUBSTANCE STABILITY / PROCESS IMPURITY CONTROLS DRUG SUBSTANCE AND EXCEPIENTS COMPACTABILITY DRUG PRODUCT STABILITY PRECLINICAL STUDY NEW MOLECULE DISCOVERY “Click” for next slide www.eapharmics.com

  4. 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 Product Recalls “Click” for next slide www.eapharmics.com

  5. Role of eSTAR in Stability Program EAPHARMICSeSTAR 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. “Click” for next slide www.eapharmics.com

  6. eSTAR – Interactive Modular Design Web based application allows controlled access from any site around the world. “Click” for next slide www.eapharmics.com

  7. Part 11 Compliance Settings The application parameters will define the overall settings for Part 11 compliance. “Click” for next slide www.eapharmics.com

  8. 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. “Click” for next slide www.eapharmics.com

  9. Grant Access User access is further limited by granting access to specific functionality “Click” for next slide www.eapharmics.com

  10. 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. “Click” for next slide www.eapharmics.com

  11. 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. “Click” for next slide www.eapharmics.com

  12. Stability Dictionaries Specification Library Study Conditions Dictionary Analyst Dictionary System Dictionaries Packaging Dictionary Reason for Study Dictionary Abbreviations Dictionary User Defined Fields Dictionary Site Dictionary “Click” for next slide www.eapharmics.com

  13. Specifications Management Product Specifications Library Protocol Design Standard Sample Inventory Design Product Specification Multiple Protocols Setup – CRT Control Room Temperature ACC – Accelerated Controlled Temperature Intermediate Setup Designs – Bracketing & Matrixing Product Information Individual Test Specification Formula Information Specification Option Sample Traceability up to Interval Level Label Control “Click” for next slide www.eapharmics.com

  14. Define Testing Matrix for Condition • Unlimited # of Matrices • Define in Months, Weeks or Days Use the specification library to define your product line. • Define Standard Inventory for Testing Matrix • “Click” in required inventory during study login • Add new products • Edit existing products • Templates to generate similar products • Define Required Tests • Unlimited # of tests • Value or text limits • Precision • Lab Location • Alert Limits • Variance Limits Define the product details “Click” for next slide www.eapharmics.com

  15. Study Login • Information: • Product • Manufacturing • Package • Site • Stability New Study Login API Information API Manufacturing API Number Raw Materials 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 Study Condition, Tests & Intervals “Click” for next slide www.eapharmics.com

  16. 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. “Click” for next slide www.eapharmics.com

  17. 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 “Click” for next slide www.eapharmics.com

  18. 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 • Additionally: • Assign the test matrix • Make label requests • Add comments • Study login approval • prior to activation • Study condition • Reason for study • Study Length • To mention a few ... “Click” for next slide www.eapharmics.com

  19. Customizable Labeling System with Bar Code • Product Name: • ID: • Specification: • Batch: • Date: • Fill: • Container: • Condition: • Interval: • Due Date: 2D Bar Code Capabilities “Click” for next slide www.eapharmics.com

  20. Label Design Select fields that needs to be in the label and design the label “Click” for next slide www.eapharmics.com

  21. Label Printing Different Types of Labels can be Designed and Printed ( Including 2D Bar Code Labels ) “Click” for next slide www.eapharmics.com

  22. 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 “Click” for next slide www.eapharmics.com

  23. Data Entry Modules • Layered Approvals for Data Entry. • Controlled Substances inventory tracking. • Sample destruction information reporting tools. • (DEA Form) “Click” for next slide www.eapharmics.com

  24. Data Evaluation Modules Parameter selection criteria to generate interactive stability data evaluation graphs “Click” for next slide www.eapharmics.com

  25. 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 “Click” for next slide www.eapharmics.com

  26. 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 “Click” for next slide www.eapharmics.com

  27. Easy Report Generation Click the report icon to instantly generate any report. “Click” for next slide www.eapharmics.com

  28. 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 “Click” for next slide www.eapharmics.com

  29. Interactive Help System &24/7 eTicket For Immediate Attention “Click” for next slide www.eapharmics.com

  30. 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 “Click” for next slide www.eapharmics.com

  31. EAPHARMICS eSTARSECURE, 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 “Click” for next slide www.eapharmics.com

  32. 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. “Click” for next slide www.eapharmics.com

  33. Contact Website: www.eapharmics.com “END” www.eapharmics.com

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