A B

C D

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郭红星 医药工程项目及管理经验分享

Pharmaceutical engineering project and management experience sharing

Reliable, Effective project management

The 5th Vogel Pharmaceutical Engineering International ForumMay 13th . 2013, Beijing, China

Horch Guo, Hongxing.guo@yahoo.comShanghai Roche Pharmaceutical Ltd.

VOGELVOGEL Content

PART I: PHARMA ENG. PROJECT MGMT

PREFACE

PART II: KEY POINTS IN PHARMA ENG.

PROJECTS MGMT

PART III: PRACTICAL APPROACHES & CASE

STUDY TO PHARMA ENG. PROJECTS

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PART I: PHARMA ENG. PROJECT MGMT

PREFACE

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Project & Project Management

Project:“A temporary endeavor undertaken to create a unique product, service or result”Program:

“A group of related projects managed in a coordinated way to obtain benefits and control not available from managing them individually.”

Operation:

“An organizational function performing the ongoing execution of activities that produce the same product or provide a repetitive service ”

Project Management:“ The application of knowledge , skills, tools and techniques toproject activities to meet the project requirements”

PMI PMBOK Fourth Edition

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Facility /Equipments projects

New builds ,Retrofit Facilities

New Equipment or Equipments line

Decommissioning and Demolition

Improvement projects

Product, Facility, Process and Equipment improvements

Audit preparation and subsequent improvement

Product Portfolio projects

New product and product transfer

Technology Transfer

IT & Automation projects

ERP implementation

System Functionality Upgrade

Process Control System (MES)VOGELVOGEL5

Pharma Eng. Project Classification Pharma Eng. Project Classification

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CriteriaSmall-scale

projectProject Facility

RetrofitNew BuildGreenfield

NewProductTransfer

NewProduction

line

Organizationalcomplexity(Departments)

2~3 > 3

Technical Complexity(Quality, Process, etc)

Noaffect Impacts

Human resource requirements(Manpower Days)

80~200 > 200

Costs(K CNY) 300

~8,000 > 8,000

Duration(Months) > 2 >6

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164

A B

C DPharma Eng. Project Life Cycle Model

Project Initiation (PI)

Feasibility study

Conceptual development (CD)

CAPEX planning

Project Planning (PP)

Basic design (BD)

Project Planning

Project Execution (PE)

Detailed design (DD)

Procurement

Construction & Commissioning (CC)

Qualification

Project Handover (PH)

Validation & Start-up

1.Feasibility 2.CD

4.BD 5. Planning

3. CAPEX

6.DD 7.Procur. 8.CC 9.Quali

10.Validation & Start up

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PART II: KEY POINTS

IN PHARMA ENG. PROJECT MGMT

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Pharma Project Management Framework –classic triangle to 9 knowledge areas

VOGELVOGEL9 Whac-a-mole ?

Time

Cost QualityPMI 9 knowledge areas

Classic Triangle

Pharma Project Management Framework –9 Knowledge Areas ,Mgmt Process & Life Cycle

10

Mgmt Process

Knowledge area

Quality Mgmt

Risk Mgmt

Time Mgmt

Cost Mgmt

Scope Mgmt

HR Mgmt

Integration Mgmt

Communication Mgmt

Procurement Mgmt

Initiating Planning Execution Controlling Closing

MA

INSU

PPO

RT

CO

RE

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World Tier

State Tier

Organization Tier

Bureau Tier

Company & Peers Tier

Pharma Project Quality Management–Quality & Compliance tiers

12

FDA Foreign Inspections in China, Y2010

cGMP Deficiencies Percent

Inadequate Lab controls 23%

Buildings/Facilities 7%

Control components, Intermediates, Raw material 7%

Records/Reports 7%

Invalidated Lab test methods 5%

QA systems 5%

EquipmentCleaning/Maintenance, CV 5%

Equipment design, size, etc. 5%

Packaging/labeling 5%

Lack of inadequate SOPs 5%

Deviation from DMF/ANDA 4%

FDA Foreign Inspections in Europe, Y2010

cGMP Deficiencies Percent

Inadequate Lab controls 13%

QA systems 11%

Lack of inadequate SOPs 10%

Equipment cleaning/Maintenance and CV 8%

Records and Reports 8%

Process Validation 8%

Production process control 7%

System Qualification (IQ/OQ) 5%

Invalidated Lab test methods 5%

Inadequate Environmental Control 4%

Pharma Project Quality Management–cGMP Deficiencies Focused

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A B

C D

165

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Pharma Project Quality Management–Poor Quality& incompliance results

13

Pharma Project Quality Management

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QMS: ISO 9001:2005 Project lifecycle Quality management

14

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魏文王问扁鹊曰：’子昆弟三人其孰最善为医？’扁鹊曰：’长兄最善，中兄次之，扁鹊最为下。’魏文侯曰：’可得闻邪？’扁鹊曰：’长兄於病视神，未有形而除之，故名不出於家。中兄治病，其在毫毛，故名不出於闾。若扁鹊者，镵血脉，投毒药，副肌肤，闲而名出闻於诸侯。’

《鶡冠子·卷下·世贤第十六》。

Pharma Project Risk Management –Case 1: Bian Que & brothers

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ICH Q9- Quality Risk Assessment ModelICH Q8/9/10- Patient linked risk assessment

Pharma Project Risk Management –Quality based Risk Assessment Model

PM & Stakeholder

Team Members

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Pharma Project HR Management –Case 2: The Journey to the West

Cos

t and

sta

ffing

leve

l

Time

Initial phase Intermediate phase Final phase

Planning Implementation

Costof Scope Changes

Curveof Life Cycle

Impactof Scope Changes

Pharma Project Schedule & Cost & Scope Magement

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166

A B

C D –Integration & Interfaces Management

Take high level view of the project from start to finish.

Consolidate and integrate many project activities and will make decision where to apply resources allocation in order to execute the project to achieve the goal.

“Integration” means changes made in any one area of the project must be integrated into the rest of projects.

Integration

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Project Integration Management Project Integration Management-Case 3: Ding Wei “kill three birds with one stone”

丁谓 - 一举三得

“一举而三役济，计省费以亿万计”

挖沟取土，解决土源 引水入沟，运输建材 废土建沟，处理垃圾

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Project Communication ManagementCase 4: Messager game

21

Conflict Management

orange

arrange

arrow

apple opera

apollo

ExecutiveLeadership

ProjectLeadership

WorkingTeam

Internal Team

ProjectLeadership

WorkingTeam

External team from Vendors

SPOC

Qualified vendor List ! Sustainable vendor evaluation criteria!

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Project Purocurement Management-Lifecycle purocurement process

t+1

Projectsupport&tracking

t+2

Vendorrevaluation.

5 4 3 2 1 0

tProject-/DemandPlanning

BiddersSelection

Requestforproposal(RFP)/Invitationto Bid (ITB)

Bidevaluation,auditing& Final Negotiation

Award PurchaseOrder/contracts

t+3

Closing

PART III: PRACTICAL APPROACHES & CASE

STUDY TO PHARMA ENG. PROJECTS

MGMT

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Pharma Eng. Project- PI Phase-Case Study : State-of-art CIP tablet compression system - Created PM Manual, Integrated Org-chart & RACI matrix

24 Project Delegation tool -RACI Matrix

Created PM Manual

Integrated Org-Chart

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A B

C D

167

Pharma Eng. Project- PI Phase-Case Study : State-of-art CIP tablet compression system - Global alignment feasibility study

China

Italy

Brazil

Mexico

25

Pharma Eng. Project- PI Phase-Case Study : State-of-art CIP tablet compression system -Occupational Exposure Limits’ Risks & Technology

26

Pharma Eng. Project- PI Phase-Case Study : State-of-art CIP tablet compression system –Quantitative evaluation summary

DRIVERS Vendor A Vendor B Vendor C

High Containment

Max Output

Production Flexibility

WIP/CIP Level

Investment Budget

Delivery Time

After Sales Services Quality

Spare Parts management

References

Layout Study

Qualification & Validation supports

Automation level27

Pharma Eng. Project- PI Phase-Case Study : State-of-art CIP tablet compression system –CAPEX Finiancial Appraisel Project EVA evaluation

28

Eng. project EVA breakdown Finiancial Appraisel

Pharma Eng. Project - PP Phase-Case Study: State-of-art CIP tablet compression system

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Pharma Eng. Project - PP Phase-Case Study : State-of-art CIP tablet compression system –Project Schedule

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168

A B

C D

Pharma Eng. Project - PP Phase-Case Study : State-of-art CIP tablet compression system –ICH Q9 Quality Risk Management (QRM) & RACI

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QRM Program SME Quality Decision Makers

QRMLead

Facilitator Site RMC

Initiate QRM Plan

- Develop Plan C C A/R I C

- Approve Plan R A/R R I I

Risk Assessment

-Plan for Risk Assessment C A/R R

-Execute Risk Assessment(Identify, Analyze, Evaluate)

R R A R

-Finalize Risk Assessment R R A R

-Approve Risk Assessment R

Risk Control

-Risk Control Decision (Reduce/AcceptRisk)

I R A/R R C

-Risk Reduction Implementation R R A R I

QRM Report I R A/R A I

Risk Review I R A R

QRM Documentation A/R R

Pharma Eng. Project - PP Phase-Case Study : State-of-art CIP tablet compression system –ICH Q9 Quality Risk Management (QRM) in V model

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Pharma Eng. Project - PP Phase-Case Study : State-of-art CIP tablet compression system –Project Execution Plan (PEP)

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Pharma Eng. Project - PE Phase-Case Study : State-of-art CIP tablet compression system –System Process P&ID

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Pharma Eng. Project - PE Phase-Case Study : State-of-art CIP tablet compression system

-Site construction

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3D simulation

35

Pharma Eng. Project - PE Phase-Case Study : State-of-art CIP tablet compression system

-Cost tracking profile

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Down payment

2nd payment

3rd payment

Final payment

Add order

Cos

t

ScheduleM

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A B

C D

169

Pharma Eng. Project - PE Phase-Case Study : State-of-art CIP tablet compression system –Project Change Management

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Reasons:

System/Plant/Location:Brief Description of Change:

Initiator: Date: Signature:Change Type:□Scope □Incident □Design □Execution □Transfer□Estimate

Reason for Change:□Safety □GMP □Function □Cost □Schedule □Authority

Brief description of solution/Alternatives:

Quality Impact Schedule Impact Cost Impact

Approval : Date: Signature:

Approval: Date: Signature:

Pharma Eng. Project - PH Phase-Case Study : State-of-art CIP tablet compression system

-Project Handover

38

No. Item Requirements Referencedocument

CompliesYes/no

Signature,Date Remarks

1 General documents

- Design and construction documents- As built Drawings- Change Management Summary- Completion Punch list-Training documents

2 Building -Final facilities walkdown Conducted-Authority permissions-Final Certificate of Occupancy -Building/Facility Turnover Checklist

3 Process -List of equipment, system-O&M Manual ,Certification, Assemble drawing and so on (including mechanical installation, electrical principle and wiring).--All test record, FAT,SAT, Qualification , validation Document-Detailed list of spare parts for 2 years operation-Maintenance plan-Tools list

4 Control System

-Data Migration Complete-Passwords for operation and setting-Configuration Management Procedures-Defect Management Procedures-Disaster Recovery -Source Code & coding standard

Project Handover list

Pharma Eng. Project - PH Phase-Case Study : State-of-art CIP tablet compression system

-Lessons LearnedFeasibility CD CAPEX BD Planning DD Procur. CC Quali Validation &

Start up

1st LL workshop 2nd LL workshop 3rd LL workshop Final LL workshop

Project Success-What went well

General Learning & Findings

Unintended Consequences, Impacts to the Project and Recommendations – What did not go well?

RCA Analysis for High Impact Incidents

LL Action Items

Description Factors that Promoted this Success

Description Identified By

What point? What was the impact? recommendations

Define Factors Corrective Action

EffectiveSolutions

Items Action Items Responsibility Deadline

Engineering Project Lessons Learned Report

39

Useful links:PM:

www.pmi.org

www.ispe.org

Global Authorities:

www.ich.org

www.fda.gov

www.ema.europa.eu

www.pda.org

www.pics.org

More information....

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Q & A

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Thanks for your attention!

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