Seminar SAP Life sciences
Presented to : Korean
Presented by :
Pharmaceutical Industry Participants
Chandra Shekar CV,
Soltius Singapore Pte Ltd
Competence Manager – Life sciences
______________________
Pharmaceutical Industry
Global and Korea
An 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
Industry
An Overview
International Regulatory agencies
WORLD HEALTH ORGANIZATION
UNITED STATES
FOOD AND DRUG
ADMINISTRATION
MEDICINES
CONTROL
AGENCY
Korea GMP
MEDICAL
CONTROL
COUNCIL
TECHNICAL
GUIDANCE
AGENCY
cGMP and Regulatory Compliance handling & Validation
USFDA
MCA
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 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
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-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)
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 Practices
Traditional project
With SAP
Best Practices
Enable
fast and
easy implementaWorking
prototype
tion of mySAP Business Suite
Demonstration of a solution that
is easy to:
 identify
with
 implement
 adapt to specific
requirements
Time and effort savings
Get a living and fully documented
prototype within days that you
can rapidly turn into a productive
solution
Identification and anticipation of reusable business processes
and project activities
SAP Best Practices Deliverables Structure
Documentation
 BP Scenario overview
 BP Business process procedures
Preconfiguration
 Preconfiguration
settings
 Master data
 Installation instruction

Step-by-step guide to be used
together with the Installation
Assistant
 Configuration
Documentation
 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 Compliance
Production 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 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)
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)
SAP Integration model for Pharmaceutical industry
Sales Order
Shipment
Customer
Sales &
Distribution
Credit Management
Material Availability Check
Transfer of Requirements
Goods Issue to Sales
Invoice
cGMP and USFDA
Sales Forecast / Plan
Accounting Document
Production &
Operation Cost
Materials
Management
Quality
Management
Finance &
Controlling
Accounts Payable
Asset
Management
Goods Receipt
Invoice Receipt
Accounts Receivable
Compliance
Material Requirements
Purchase Order
Production
Planning in
Process Ind.
Quality
Management
Goods issue to Process Order
Process Order Receipt
Vendor
Pharmavision
What is Pharmavision ?
SAP
Best Practices
+
Add-ons
Pharmaceutical Industry specific
Add-ons
SOLTIUS
Pharma
Expertise
“Pharmavision”
•
Pre-configured Features
•
Enhanced Features
•
Custom Features
•
Validation Support Features
Features - 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
Audit Trails
Batch classification
Custom PI sheets (Electronic Batch records - 21 CFR Part 11)
Pharmavision comes with support for…
COMPUTERIZED SYTEMS VALIDATION – GAMP4 GUIDELINES
21 CFR PART 11 VALIDATION – USFDA GUIDELINES
Validation Master Plan
Audit Reports template
Sample IQ/PQ/OQ Protocols
System Maintenance Documentation
Continuous validation plan
Functional Requirement Spec’s (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:
•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 – LG Life sciences, Korea
• 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 – Diethelm Keller Sieber Hegner Grp
• 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
Other Engagements in Life Sciences Industry
Pharma Formulations, Diagnostics, Bio Tech, Clinical Trials
• Bristol Myers Squibb
Wyeth Labs
Johnson & Johnson
Sterling Diagnostics
Wella Products
• PT. Anugerah Pharmindo Lestari
Eli Lily
Qualigen Life Sciences
Glaxo Smith Klein
SKW Bio systems
• Paddock Labs
• PT. Combiphar
• Warner Lambert
• Siemens Medical Systems
• Purdue Pharmaceuticals
• EnMed
• Med Pointe
• Dade Behring
21 CFR Part 11 in SAP
Sample
Electronic Batch Record
Digital signatures for
Resource check
Integration with
Document
management system
for on-line S.O.P’s
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 SAP
Demo
Questions?
More Information: Contact
cvchandrashekar@gmail.com