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Seminar SAP Life sciencesPresented to : KoreanPresented by :
Pharmaceutical Industry Participants
Chandra Shekar CV,Soltius Singapore Pte Ltd Competence Manager Life sciences
______________________
Pharmaceutical Industry Global and KoreaAn Overview
Global Pharmaceutical Industry
Annual Average Growth of 10%
(Source : BCC, Inc. "World Pharmaceutical Markets" 2004) Estimated US $ 900 Billion in 2010
Korean Pharmaceutical Industry
(Source : KPMA *** Excludes API/Intermediates)
Korean Pharmaceutical Companies
(Source : KPMA, 2006)
Korean Pharmaceutical Companies
SAP Best Practices implementation with Pharmaexpress**
USFDA inspection in 2004-2005 accepted the Computer systems validation
(Source : KDRA, 2006)
(** Pharmaexpress renamed Pharmavision in 2005)
Regulations in Pharmaceutical IndustryAn Overview
International Regulatory agenciesWORLD HEALTH ORGANIZATION Korea GMP
UNITED STATES FOOD AND DRUG ADMINISTRATION
MEDICINES CONTROL AGENCY
MEDICAL CONTROL COUNCIL
TECHNICAL GUIDANCE AGENCY
cGMP and Regulatory Compliance handling & Validation
MCA USFDA MHRA MCC TGA
Software compliance requirements for the above are the key features of SAP Best practices and Pharmavision
Regulations in the Pharmaceutical Industry 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 Administration21 Code of Federal Regulations21CFR, 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 paper21CFR, part 210
FDA's Current Good Manufacturing Practices in Manufacturing, Processing, Packing, or Holding of Drugs; general21 CFR, part 211
FDA's Current Good Manufacturing Practice for Finished Pharmaceuticals
What is USFDA 21 CFR Part 11 ?A set of rules formulated by USFDA governing access, storage, retrieval, control and security of Electronic records A set of rules governing security, control and use of electronic signatures The basis by which Electronic records and signatures may be used as equivalents to paper records and traditional handwritten signatures
Examples of E-recordsBatch 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)
SAP Best Practices for Pharmaceuticals
SAP Best Practices 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 PracticesTraditional project
Enable fast and easy implementaWorking prototype tion of mySAP Business Suite With SAP Best Practices Demonstration of a solution that is easy to: identify
with implement adapt to specific requirementsGet a living and fully documented prototype within days that you can rapidly turn into a productive solution
Time and effort savings
Identification and anticipation of reusable business processes and project activities
SAP Best Practices Deliverables Structure
Documentation BP Scenario overview BP Business process procedures Installation instruction
Preconfiguration Preconfiguration settings Master data Configuration Documentation Installation Assistant
Step-by-step guide to be used together with the Installation Assistant
Best Practices Configuration Guide for all scenarios
Definition and documentation of integrated business processes
Preconfigured configuration settings and installation automation
Some GMP relevant functions 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
SAP GMP Relevant modules for 21 CFR Part 210 ComplianceProduction Planning (PP Module) Process execution (PI Module) Materials Management (MM Module)
Some GMP relevant functions contd Return and Complaints Processing Batch Recall QM in Manufacturing QM in Sales QM Basics PP-PI Basics Cross-Company Delivery Integration of DMS Engineering Change Management Stability Study in QM Part 11 Tool Configuration
SAP GMP Relevant modules for 21 CFR Part 211 ComplianceSales and Distribution module (SD Module)
SAP GMP Relevant modules for 21 CFR Part 210 and 211Quality management (QM Module) Warehouse management (WM Module)
Other SAP GMP Relevant modules for 21 CFR Part 210 CompliancePlant Maintenance (Instrument calibrations and Equipment history) Project Systems (R&D Projects) APO (Batch recall network)
SAP Integration model for Pharmaceutical industryCustomerSales Order Shipment Credit Management Sales Forecast / Plan
Sales & DistributionInvoice
Material Availability Check Transfer of Requirements Goods Issue to Sales
cGMP and USFDAMaterial Requirements Compliance Production & Operation Cost Goods issue to Process Order Process Order Receipt
Production Planning in Process Ind. Quality Management
Materials Management Quality ManagementPurchase Order Goods Receipt Invoice Receipt
Accounting Document
Accounts Receivable
Finance & Controlling
Accounts Payable
Vendor
Asset Management
Pharmavision
What is Pharmavision ?
SAP Best Practices
+SOLTIUS Pharma Expertise
Add-ons
Pharmaceutical Industry specific Add-ons
Pre-configured FeaturesEnhanced Features Custom Features
Validation Support Features
Pharmavision
Features - Pharmavision ?Enhanced and Custom features Enhanced Change Management Enhanced Quality control
Manufacture at riskQuality status label management Batch re-work process Pipe line material Inspection Audit Trails
Ship on holdCustom inventory movements Manufacturers part control Custom reports Batch classification
Custom PI sheets (Electronic Batch records - 21 CFR Part 11)
Pharmavision comes with support forCOMPUTERIZED SYTEMS VALIDATION GAMP4 GUIDELINES 21 CFR PART 11 VALIDATION USFDA GUIDELINES
Validation Master PlanSample IQ/PQ/OQ Protocols Continuous validation plan
Audit Reports templateSystem Maintenance Documentation Functional Requirement Specs (FRS)
User Acceptance/Integration Testing Protocol User related application SOPs templates 21 CFR part II validation protocol for Digital signatures Rigorous Change Control And Problem Reporting
Success story Paddock Laboratories Inc. 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 MedPointe 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 months
Success story PT. Combiphar
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 months
Success story LG Life sciences, Korea LG Life Sciences (LGLS) is a leading pharmaceuticalCompany based in Seoul, Korea
Pharmaceuticals Division, Agrochemicals Division, animal healthDivision 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 Diethelm Keller Sieber Hegner Grp
DKSH is a leading Pharmaceutical and Healthcare distributorglobally
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
Other Engagements in Life Sciences IndustryPharma Formulations, Diagnostics, Bio Tech, Clinical TrialsBristol Myers Squibb Sterling Diagnostics Wella Products
Wyeth LabsJohnson & Johnson Eli Lily
PT. Anugerah Pharmindo LestariQualigen Life Sciences SKW Bio systems
Glaxo Smith KleinPaddock Labs Warner Lambert
PT. CombipharSiemens Medical Systems EnMed
Purdue PharmaceuticalsMed Pointe
Dade Behring
21 CFR Part 11 in SAPSample
Electronic Batch Record
Digital signatures for Resource check
Integration with Document management system for on-line S.O.Ps
Electronic SOP in Batch Records
Electronic Signatures
Notes for Resource status with digital signatures
Deviation rules, check and approval procedures
Custom Reports
Custom reports in Production planning and Inventory Mgmt.
Batch Re-work Audit trail report
Custom movements for consumption in Batch reworks
Audit Trails in SAPDemo
Questions?
More Information: Contact cvchandrashekar@gmail.com
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