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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 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 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 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 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
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 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


Customer
Sales Order Shipment Credit Management Sales Forecast / Plan

Sales & Distribution


Invoice

Material Availability Check Transfer of Requirements Goods Issue to Sales

cGMP and USFDA


Material Requirements Compliance Production & Operation Cost Goods issue to Process Order Process Order Receipt

Production Planning in Process Ind. Quality Management

Materials Management Quality Management


Purchase 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 Features
Enhanced Features Custom Features

Validation Support Features

Pharmavision

Features - Pharmavision ?
Enhanced and Custom features Enhanced Change Management Enhanced Quality control

Manufacture at risk
Quality status label management Batch re-work process Pipe line material Inspection Audit Trails

Ship on hold
Custom inventory movements Manufacturers part control Custom reports 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


Sample IQ/PQ/OQ Protocols Continuous validation plan

Audit Reports template


System 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 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 Wella Products

Wyeth Labs
Johnson & Johnson Eli Lily

PT. Anugerah Pharmindo Lestari


Qualigen Life Sciences SKW Bio systems

Glaxo Smith Klein


Paddock Labs Warner Lambert

PT. Combiphar
Siemens Medical Systems EnMed

Purdue Pharmaceuticals
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.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 SAP


Demo

Questions?

More Information: Contact cvchandrashekar@gmail.com

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