Seminar SAP Life sciences

Presented to : Korean Pharmaceutical Industry Participants

Presented by : 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 Korea GMP

UNITED STATES MEDICINES MEDICAL TECHNICAL

FOOD AND DRUG CONTROL CONTROL GUIDANCE
ADMINISTRATION AGENCY COUNCIL AGENCY

cGMP and Regulatory Compliance handling & Validation

MCA
USFDA MCC TGA
MHRA

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
Enable fast and
Working easy implementa-
prototype
tion of mySAP Business Suite
With SAP
Best Practices Demonstration of a solution that
is easy to:
 identifywith
 implement
 adapt to specific
requirements

Get 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 Preconfiguration

 BP Scenario overview  Preconfiguration

 BP Business process procedures settings
 Master data
 Configuration
 Installation instruction Documentation
 Step-by-step guide to be used
 Installation
together with the Installation
Assistant
Assistant
 Best Practices Configuration Guide

… for all scenarios

Definition and documentation of Preconfigured configuration settings

integrated business processes 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 • Cross-Company Delivery
• Batch Recall • Integration of DMS
• QM in Manufacturing • Engineering Change
• QM in Sales Management
• QM Basics • Stability Study in QM
• PP-PI Basics • 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
Material Availability Check
Sales Order
Customer Shipment Sales & Transfer of Requirements

Credit Management Distribution Goods Issue to Sales

Invoice
cGMP and USFDA
Sales Forecast / Plan

Goods issue to Process Order

Production Process Order Receipt
Planning in Compliance
Material Requirements
Materials
Management
Process Ind. Accounting Document
Quality Production & Quality
Operation Cost
Management Management

Purchase Order
Invoice Receipt
Goods Receipt
Finance & Accounts Payable Vendor
Accounts Receivable
Controlling
Asset
Management
Pharmavision
What is Pharmavision ?

SAP
Best Practices + Add-ons
Pharmaceutical Industry specific

Add-ons
SOLTIUS • Pre-configured Features
Pharma
Expertise
• Enhanced Features

• Custom Features

• Validation Support Features

“Pharmavision”
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 Sterling Diagnostics

Wyeth Labs Wella Products

Johnson & Johnson • 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