SAP in regulated pharmacetical industry - Overview

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

11. SAP Best Practices for Pharmaceuticals

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

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

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

36. More Information: Contact [email_address] Questions?