Seminar SAP Life sciencesChandra Shekar CV, Soltius Singapore Pte Ltd Competence Manager Life sciences______________________ Presented to :Korean Pharmaceutical Industry ParticipantsPresented by :

Pharmaceutical IndustryGlobal and Korea An Overview

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

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

Korean Pharmaceutical Companies(Source : KPMA, 2006)

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

Regulations in Pharmaceutical Industry An Overview

USFDAMCAMHRAMCCTGAcGMP and Regulatory Compliance handling & ValidationInternational Regulatory agenciesUNITED STATES FOOD AND DRUG ADMINISTRATIONMEDICINES CONTROL AGENCYMEDICAL CONTROL COUNCILTECHNICAL GUIDANCE AGENCYWORLD HEALTH ORGANIZATIONSoftware compliance requirements for the above are the key features of SAP Best practices and PharmavisionKorea GMP

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 countriesUSFDA 21 CFR United States Food and Drugs Administration 21 Code of Federal Regulations

21CFR, part 11FDA'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 210FDA'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 PharmaceuticalsRegulations in the Pharmaceutical Industry

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

SAP Best Practices for Pharmaceuticals

What is SAP Best PracticesProduct descriptionDeliverablesConcept of UseSAP Best Practices: InstallationQuick InstallationSAP Best Practices ToolsBuilding Block PrincipleBuilding Block ApproachBuilding Blocks Overview ListPreconfigured Business ScenariosBenefits of SAP Best PracticescGMP compliance in the GMP relevant functional modules

SAP Best Practices

SAP Best PracticesWith SAP Best Practices Traditional projectTime and effort savings

Working prototype

Get a living and fully documentedprototype within days that you can rapidly turn into a productive solutionEnable fast and easy implementa-tion of mySAP Business SuiteIdentification and anticipation of reusable business processes and project activities

SAP Best Practices Deliverables StructureDefinition and documentation of integrated business processesPreconfigured configuration settingsand installation automation

for all scenariosPreconfiguration settingsMaster dataConfiguration DocumentationInstallation AssistantPreconfigurationDocumentationBP Scenario overviewBP Business process proceduresInstallation instructionStep-by-step guide to be used together with the Installation AssistantBest Practices Configuration Guide

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 materialsSome GMP relevant functionsSAP GMP Relevant modules for 21 CFR Part 210 Compliance

Production Planning (PP Module) Process execution (PI Module) Materials Management (MM Module)

Return and Complaints Processing Batch Recall QM in Manufacturing QM in Sales QM Basics PP-PI Basics Some GMP relevant functions contdSAP 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 ConfigurationOther 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)

InvoiceSAP Integration model for Pharmaceutical industryMaterial Availability CheckcGMP and USFDA

ComplianceAsset ManagementQuality ManagementQuality ManagementSales &DistributionProductionPlanning in Process Ind.MaterialsManagementFinance &ControllingCustomerSales OrderShipmentAccounts ReceivableCredit ManagementTransfer of RequirementsGoods Issue to SalesGoods ReceiptInvoice Receipt

Purchase OrderAccounts PayableAccounting DocumentProduction & Operation CostGoods issue to Process OrderProcess Order ReceiptSales Forecast / PlanVendorMaterial Requirements

Pharmavision

SAPBest Practices+Add-onsSOLTIUS Pharma ExpertisePharmavisionPharmaceutical Industry specific Add-ons

Pre-configured Features

Enhanced Features

Custom Features

Validation Support Features

What is Pharmavision ?

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

Pharmavision comes with support for21 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 Specs (FRS)

COMPUTERIZED SYTEMS VALIDATION GAMP4 GUIDELINES

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.

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 monthsSuccess story MedPointe Inc.

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:Combiphars 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 monthsSuccess story PT. Combiphar

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

DKSH is a leading Pharmaceutical and Healthcare distributor globallySole 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 2005Vietnam and Thailand in 2006Philippines in 2007Success story Diethelm Keller Sieber Hegner Grp

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 IndustryPharma Formulations, Diagnostics, Bio Tech, Clinical Trials

21 CFR Part 11 in SAP Sample

Integration with Document management system for on-line S.O.PsDigital signatures for Resource checkElectronic Batch Record

Electronic SOP in Batch Records

Notes for Resource status with digital signatures Electronic Signatures

Deviation rules, check and approval procedures

Custom reports in Production planning and Inventory Mgmt. Custom Reports

Custom movements for consumption in Batch reworksBatch Re-work Audit trail report

Audit Trails in SAP Demo

More Information: Contactcvchandrashekar@gmail.com

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