The document discusses the global and Korean pharmaceutical industries and regulations. It provides an overview of SAP Best Practices solutions and Pharmavision add-ons for compliance with FDA 21 CFR Part 11 regulations. Case studies are presented of pharmaceutical companies that successfully implemented SAP Best Practices and Pharmavision.

1. Seminar SAP Life sciences Chandra Shekar CV , Soltius Singapore Pte Ltd Competence Manager – Life sciences ______________________ Presented to : Korean Pharmaceutical Industry Participants Presented by :

2. Pharmaceutical Industry Global and Korea An Overview

3. Global Pharmaceutical Industry (Source : BCC, Inc. "World Pharmaceutical Markets" 2004) Annual Average Growth of 10% Estimated US $ 900 Billion in 2010

4. Korean Pharmaceutical Industry (Source : KPMA *** Excludes API/Intermediates)

5. Korean Pharmaceutical Companies (Source : KPMA, 2006)

6. Korean Pharmaceutical Companies (Source : KDRA, 2006) SAP Best Practices implementation with Pharmaexpress** (** Pharmaexpress renamed Pharmavision in 2005) USFDA inspection in 2004-2005 accepted the Computer systems validation

7. Regulations in Pharmaceutical Industry An Overview

8. USFDA MCA MHRA MCC TGA cGMP and Regulatory Compliance handling & Validation International Regulatory agencies UNITED STATES FOOD AND DRUG ADMINISTRATION MEDICINES CONTROL AGENCY MEDICAL CONTROL COUNCIL TECHNICAL GUIDANCE AGENCY WORLD HEALTH ORGANIZATION Software compliance requirements for the above are the key features of SAP Best practices and Pharmavision Korea GMP

9. GMP – Good Manufacturing Practices GMP outlines the regulations and guidelines within a specific country for medical products manufactured in that country or imported from other countries USFDA 21 CFR – United States Food and Drugs Administration 21 Code of Federal Regulations 21CFR, part 11 FDA's Standards for the use of electronic records and signatures as an equivalent and/or substitute for paper records and handwritten signatures executed on paper 21CFR, part 210 FDA's Current Good Manufacturing Practices in Manufacturing, Processing, Packing, or Holding of Drugs; general 21 CFR, part 211 FDA's Current Good Manufacturing Practice for Finished Pharmaceuticals Regulations in the Pharmaceutical Industry

10. Examples of E-records Batch Records ( Manufacturing records) Compliance Records ( Validation IQ / OQ / PQ Protocols) Laboratory data ( Routine inspection, Stability sample management) Manufacturing data (Master formulation record, Master Packaging record) Training records ( cGMP 21 CFR Part 210, 211 and Part 11) Calibration tracking records ( Laboratory equipments ) Audit trails ( Deviations listing, Resource logs) A set of rules formulated by USFDA governing access, storage, retrieval, control and security of Electronic records What is USFDA 21 CFR Part 11 ? The basis by which Electronic records and signatures may be used as equivalents to paper records and traditional handwritten signatures A set of rules governing security, control and use of electronic signatures

11. SAP Best Practices for Pharmaceuticals

12. What is “SAP Best Practices“ Product description Deliverables Concept of Use SAP Best Practices: Installation “ Quick” Installation SAP Best Practices Tools Building Block Principle Building Block Approach Building Blocks Overview List Preconfigured Business Scenarios Benefits of SAP Best Practices cGMP compliance in the GMP relevant functional modules SAP Best Practices

13. SAP Best Practices Standard/Add-on System With SAP Best Practices Standard/Add-on-System Traditional project SAP Best Practices Adjustments within project Time and effort savings Working prototype Get a living and fully documented prototype within days that you can rapidly turn into a productive solution Enable fast and easy implementa- tion of mySAP Business Suite Adjustments within project Identification and anticipation of reusable business processes and project activities Demonstration of a solution that is easy to: identify with implement adapt to specific requirements

14. SAP Best Practices Deliverables Structure Definition and documentation of integrated business processes Preconfigured configuration settings and installation automation … for all scenarios Preconfiguration settings Master data Configuration Documentation Installation Assistant Preconfiguration Documentation BP Scenario overview BP Business process procedures Installation instruction Step-by-step guide to be used together with the Installation Assistant Best Practices Configuration Guide

15. Batch Management Batch Information Cockpit Active Ingredient Processing Integration of Warehouse Management Procurement of stock material Regulated Manufacturing Subcontracting Integration of Weighing system Electronic Batch Recording Process Manufacturing Cockpit Expiry Date Calculation QM in Procurement Samples and advertising materials Some GMP relevant functions SAP GMP Relevant modules for 21 CFR Part 210 Compliance Production Planning (PP Module) Process execution (PI Module) Materials Management (MM Module)

16. Return and Complaints Processing Batch Recall QM in Manufacturing QM in Sales QM Basics PP-PI Basics Some GMP relevant functions – contd… SAP GMP Relevant modules for 21 CFR Part 211 Compliance Sales and Distribution module (SD Module) SAP GMP Relevant modules for 21 CFR Part 210 and 211 Quality management (QM Module) Warehouse management (WM Module) Cross-Company Delivery Integration of DMS Engineering Change Management Stability Study in QM Part 11 Tool Configuration Other SAP GMP Relevant modules for 21 CFR Part 210 Compliance Plant Maintenance (Instrument calibrations and Equipment history) Project Systems (R&D Projects) APO (Batch recall network)

17. Invoice SAP Integration model for Pharmaceutical industry Material Availability Check cGMP and USFDA Compliance Asset Management Quality Management Quality Management Sales & Distribution Production Planning in Process Ind. Materials Management Finance & Controlling Customer Sales Order Shipment Accounts Receivable Credit Management Transfer of Requirements Goods Issue to Sales Goods Receipt Invoice Receipt Purchase Order Accounts Payable Accounting Document Production & Operation Cost Goods issue to Process Order Process Order Receipt Sales Forecast / Plan Vendor Material Requirements

18. Pharmavision

19. SAP Best Practices + Add-ons SOLTIUS Pharma Expertise “ Pharmavision” Pharmaceutical Industry specific Add-ons Pre-configured Features Enhanced Features Custom Features Validation Support Features What is Pharmavision ?

20. Enhanced and Custom features Enhanced Change Management Enhanced Quality control Manufacture at risk Ship on hold Quality status label management Custom inventory movements Batch re-work process Manufacturers part control Pipe line material Inspection Custom reports Custom PI sheets (Electronic Batch records - 21 CFR Part 11) Features - Pharmavision ? Audit Trails Batch classification

21. Pharmavision comes with support for… 21 CFR PART 11 VALIDATION – USFDA GUIDELINES Validation Master Plan Audit Reports template Sample IQ/PQ/OQ Protocols System Maintenance Documentation Continuous validation plan 21 CFR part II validation protocol for Digital signatures Rigorous Change Control And Problem Reporting User Acceptance/Integration Testing Protocol User related application SOPs templates Functional Requirement Spec’s (FRS) COMPUTERIZED SYTEMS VALIDATION – GAMP4 GUIDELINES

22. A provider of specialty pharmaceutical products based in Minneapolis, Minnesota Pharmavision has been customized to Paddock's needs and addresses the company's core business process and key manufacturing areas; Procurement and Sales and Distribution Inventory Management and Warehouse Management Process Manufacturing and Quality Management Finance, Profitability Analysis and Reporting ASP plus Hosting is powered by AT&T's Ecosystem Success story – Paddock Laboratories Inc.

23. A provider of specialty respiratory, cough/cold, pediatric and central nervous system products and maintains a manufacturing facility in Decatur, USA Pharmavision has been implemented to the company's core business process and key manufacturing areas, the company went live in Dec 2002: Med Pointe's financials, order management, procurement, inventory management, batch management and lot trace ability, process manufacturing, quality management, distribution, DEA reporting, custom interfaces and charge back processes Effectively employed the solution in only six months Success story – MedPointe Inc.

24. A provider of specialty respiratory, cough/cold, pediatric and central nervous system products and anti cancer drugs maintains a manufacturing facility in Indonesia Pharmavision has been implemented to the company's core business process and key manufacturing areas, the company went live in July 2002: Combiphar’s financials, order management, procurement, inventory management, batch management and lot trace ability, quality management, distribution, custom Warehouse management solutions and localized Legal requirements were customized in the Pharmavision Effectively employed the solution in only six months Success story – PT. Combiphar

25. LG Life Sciences (LGLS) is a leading pharmaceutical Company based in Seoul, Korea Pharmaceuticals Division, Agrochemicals Division, animal health Division Antibiotic Factive developed by LG Life Sciences has obtained the formal approval from the U.S. Federal Drug Administration, becoming the first Korean new medicine to be endorsed by the prestigious American agency Confronted with ongoing regulatory constraints imposed upon by the FDA. The most significant issue is upon others 21CFR Part 11 Decision was made on SAP Best practices with Pharmavision and Computer systems validation and Part 11 validation in 2003 Project was successfully completed in Jan 2004 USFDA inspection in Jun 2004 accepted the validation of the computer systems Success story – LG Life sciences, Korea

26. DKSH is a leading Pharmaceutical and Healthcare distributor globally Sole distributor for multinationals like GSK, Roche and Novartis Decided on a centralized SAP system based in Malaysia SAP successfully implemented in China, Vietnam, Indonesia, Thailand and Philippines cGMP compliance with 21CFR Part 210 Validation of computerized systems based on GAMP4 guidelines China rollout in 2005 Vietnam and Thailand in 2006 Philippines in 2007 Success story – Diethelm Keller Sieber Hegner Grp

27. Sterling Diagnostics Wella Products PT. Anugerah Pharmindo Lestari Qualigen Life Sciences SKW Bio systems PT. Combiphar Siemens Medical Systems EnMed Dade Behring Bristol Myers Squibb Wyeth Labs Johnson & Johnson Eli Lily Glaxo Smith Klein Paddock Labs Warner Lambert Purdue Pharmaceuticals Med Pointe Other Engagements in Life Sciences Industry Pharma Formulations, Diagnostics, Bio Tech, Clinical Trials

28. 21 CFR Part 11 in SAP Sample

29. Integration with Document management system for on-line S.O.P’s Digital signatures for Resource check Electronic Batch Record

30. Electronic SOP in Batch Records

31. Notes for Resource status with digital signatures Electronic Signatures

32. Deviation rules, check and approval procedures

33. Custom reports in Production planning and Inventory Mgmt. Custom Reports

34. Custom movements for consumption in Batch reworks Batch Re-work Audit trail report

35. Audit Trails in SAP Demo

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