pharma industry sap
DESCRIPTION
Pharma IndustryTRANSCRIPT
Seminar SAP Life sciences
Chandra Shekar CV, Soltius Singapore Pte Ltd Competence Manager – Life sciences
______________________
Presented to : Korean Pharmaceutical Industry ParticipantsPresented by :
Pharmaceutical IndustryPharmaceutical IndustryGlobal and KoreaGlobal 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 Regulations in Pharmaceutical IndustryIndustry
An Overview
USFDAMCA
MHRAMCC 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
GMP – Good Manufacturing Practices
GMP outlines the regulations and guidelines within a specific country for outlines the regulations and guidelines within a specific country for
medical products manufactured in that country or imported from other medical products manufactured in that country or imported from other
countriescountries USFDA 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 FDA's Standards for the use of electronic records and signatures as an equivalent and/or substitute for paper records and handwritten signatures equivalent and/or substitute for paper records and handwritten signatures executed on paperexecuted on paper
21CFR, part 210FDA's Current Good Manufacturing Practices in Manufacturing, Processing, FDA's Current Good Manufacturing Practices in Manufacturing, Processing,
Packing, or Holding of Drugs; generalPacking, or Holding of Drugs; general
21 CFR, part 211FDA's Current Good Manufacturing Practice for Finished PharmaceuticalsFDA's Current Good Manufacturing Practice for Finished Pharmaceuticals
Regulations 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)
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
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
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 signaturesA set of rules governing security, control and use of electronic signatures
SAP Best Practices for SAP Best Practices for PharmaceuticalsPharmaceuticals
• 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
SAP Best Practices
With SAP Best Practices
Traditional project
Time and effort savings
Working prototype
Get a living and fully documentedprototype within days that you can rapidly turn into a productivesolution
Demonstration of a solution that is easy to:
identify with implement adapt to specific
requirements
Enable fast and easy implementa-tion of mySAP Business Suite
Identification and anticipation of reusable business processes and project activities
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
ConfigurationDocumentation
Installation Assistant
PreconfigurationDocumentation
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
• 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
• 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)
SAP 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
• 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)
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
• 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)
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)
Invoice
SAP Integration model for Pharmaceutical industryMaterial Availability Check
cGMP and USFDAcGMP and USFDA
ComplianceCompliance
Asset Management
Asset Management
Quality Management
Quality Management
Quality Management
Quality Management
Sales &Distribution
Sales &Distribution
ProductionPlanning in Process Ind.
ProductionPlanning in Process Ind.
MaterialsManagement
MaterialsManagement
Finance &ControllingFinance &Controlling
CustomerCustomerSales Order
Shipment
Accounts Receivable
Credit Management
Transfer of Requirements
Goods Issue to Sales
Goods
Rece
ipt
Invoice
R
ece
ipt
Purch
ase
O
rder
Accounts Payable
Accounting DocumentProduction & Operation Cost
Goods issue to Process OrderProcess Order Receipt
Sales Forecast / Plan
VendorVendor
Material Requirements
Pharmavision Pharmavision
SAPBest 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 ?
Enhanced and Custom featuresEnhanced and Custom features
Enhanced Change ManagementEnhanced Change Management Enhanced Quality controlEnhanced Quality control
Manufacture at riskManufacture at risk Ship on holdShip on hold
Quality status label management Quality status label management Custom inventory movements Custom inventory movements
Batch re-work process Batch re-work process Manufacturers part control Manufacturers part control
Pipe line material Inspection Pipe line material Inspection Custom reports Custom reports
Custom PI sheets (Electronic Batch records - 21 CFR Part 11)Custom PI sheets (Electronic Batch records - 21 CFR Part 11)
Features - Pharmavision ?
Audit Trails Audit Trails Batch classification Batch classification
Pharmavision comes with support for…
21 CFR PART 11 VALIDATION – USFDA GUIDELINES21 CFR PART 11 VALIDATION – USFDA GUIDELINES
Validation Master PlanValidation Master Plan Audit Reports templateAudit Reports template
Sample IQ/PQ/OQ ProtocolsSample IQ/PQ/OQ Protocols System Maintenance DocumentationSystem Maintenance Documentation
Continuous validation planContinuous validation plan
21 CFR part II validation protocol for Digital signatures21 CFR part II validation protocol for Digital signatures
Rigorous Change Control And Problem ReportingRigorous Change Control And Problem Reporting
User Acceptance/Integration Testing ProtocolUser Acceptance/Integration Testing Protocol
User related application SOPs templatesUser related application SOPs templates
Functional Requirement Spec’s (FRS)Functional Requirement Spec’s (FRS)
COMPUTERIZED SYTEMS VALIDATION – GAMP4 GUIDELINESCOMPUTERIZED 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 months
Success 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:
•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
• 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 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
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 TrialsPharma Formulations, Diagnostics, Bio Tech, Clinical Trials
21 CFR Part 11 in SAP21 CFR Part 11 in SAP
Sample
Integration with Document
management system for on-line S.O.P’s
Digital signatures for Resource check
Electronic 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 reworks
Batch Re-work Audit trail report
Audit Trails in SAPAudit Trails in SAP
Demo
