Guideline - CoE PH Project Governance

Document No.
Ver Date Status Page

PEM-0100.00.00-01N00-001-PH-0 1.0en 2021-03-15 EFFECTIVE 1 of 26
Title
Guideline - Project Governance for Global Projects in CoE Pharma
Business area HC-PH
Location Global
Management of this Document

Role Name Signature
Responsibility Title Date
Irene Stabl Digital unterschrieben

Author Support to Global PMO,
Subject Matter CoE Pharmaceuticals, Irene Stabl von Irene Stabl
Datum: 2021.03.08
Owner Hospital Care Division, B. Braun 11:53:01 +01'00'
Melsungen AG
daufpede daufpede
Peter Daufenbach Digital signiert von:
Reviewed Director Innovation & Strategy,
Subject Matter Global Process Engineering, CoE
Expert Pharmaceuticals, Hospital Care Datum: 2021.03.15
Division, B. Braun Melsungen AG 15:10:52 +01'00'
Juan Gil Béjar Digitally signed

Reviewed Director Global Product Lifecycle
Subject Matter
Expert
Management, CoE Pharmaceuticals,
Hospital Care Division, B. Braun
gilbjode by gilbjode
Date: 2021.03.15
Melsungen AG 15:23:42 +01'00'
Rildo Feirrera-Campos Digital

Reviewed Senior Project Manager, Digital Rildo Ferreira unterschrieben von
Rildo Ferreira Campos
Subject Matter Process Dev., CoE Pharmaceuticals,
Expert Hospital Care Division, B. Braun Campos Datum: 2021.03.16
Melsungen AG 14:19:33 +01'00'
CKN 110 - Project Governance

Alternate Document No.
Document No. Ver Date Status Page
Title
Dr. Sandra
Dr. Sandra Fürmeier Digital unterschrieben von Dr. Sandra
Fürmeier
Approved Director Project, Portfolio and Alliance DN: cn=Dr. Sandra Fürmeier, o=B.Braun
Melsungen AG, ou=Director Project-
Global PMO Management, CoE Pharmaceuticals,
Fürmeier
Portfolio- & Alliance Management,
CoE PH Hospital Care Division, B. Braun email=sandra.fuermeier@bbraun.com,
c=DE
Melsungen AG Datum: 2021.03.16 15:49:39 +01'00'
Digital
Dr. Michael
Approved Dr. Michael Pietsch
Business Owner Senior Vice President, CoE unterschrieben von
Dr. Michael Pietsch
Pietsch
CoE PH Pharmaceuticals, Hospital Care
Division, B. Braun Melsungen AG Datum: 2021.03.16
15:47:15 +01'00'
Approved
CKN Workgroup
Mazdak Mahdavi-Azar
Senior Manager, Corporate Project
mahdma Digital unterschrieben
von mahdmade
de
Datum: 2021.03.08
Lead Management Office, B. Braun SE
16:14:10 +01'00'

Title
Table of Contents
Page
1 INTRODUCTION ...................................................................................................................................... 4
1.1 DOCUMENT OWNERSHIP & AUTHORITY.............................................................................................. 4
1.2 PURPOSE & SCOPE .......................................................................................................................... 4
1.3 RELATIONSHIP TO OTHER DOCUMENTS ............................................................................................. 4
2 OVERVIEW .............................................................................................................................................. 4
3 PROJECT GOVERNANCE ..................................................................................................................... 5
3.1 IMPORTANCE OF PROJECT GOVERNANCE .......................................................................................... 5
3.2 PROJECT CATEGORIZATION .............................................................................................................. 5
3.3 PROJECT GOVERNANCE DECISION AUTHORITIES & RESPONSIBILITIES IN COE PH (GLOBAL PROJECTS)6
3.4 PHASE GATE APPROVAL DECISIONS AND PHASE GATE READINESS REVIEWS IN COE PH (GLOBAL
PROJECTS) ...................................................................................................................................... 8
3.4.1 Specific Product Lifecycle for Pharmaceutical Products in CoE PH ....................................... 11
3.4.2 Phase Gate Approach for Global Product Development Projects: ......................................... 12
3.4.3 Phase Gate Approach for Global Product Modification (PLCM) Projects in CoE PH: ............ 17
3.4.4 Phase Gate Approach for Global Technical Projects in CoE PH: ........................................... 18
3.4.5 Global Digitalization Projects:.................................................................................................. 20
3.5 PROJECT GOVERNANCE PLAN ......................................................................................................... 21
3.6 PERIODIC PROJECT (PERFORMANCE) REVIEWS BY MANAGEMENT .................................................... 22
3.6.1 Regular Monthly Project Review Meetings (within regular PG meetings) .............................. 22
3.6.2 Extended Project Performance Review Meetings for Category A Projects ............................ 23
3.7 PROJECT MANAGER APPOINTMENT & LIMIT OF AUTHORITY ............................................................... 24
4 APPENDICES TO THE GUIDELINE ..................................................................................................... 25
M1 VERSION HISTORY .............................................................................................................................. 26
M2 CHANGE SUMMARY ............................................................................................................................ 26

Title
1 INTRODUCTION
1.1 DOCUMENT OWNERSHIP & AUTHORITY

This document is based on PEM Guideline – Project Governance PEM-0100.00.00.-01N00-001-0-0
and is issued by Global PMO Pharma
1.2 PURPOSE & SCOPE

This document defines Project Governance for Global Projects at the CoE Pharma
Project Governance is focused on the project lifecycle. Project Governance refers to the set of
policies, regulations, functions, processes, procedures and responsibilities that define the
establishment, management and control of projects, programs and project portfolios.
1.3 RELATIONSHIP TO OTHER DOCUMENTS

Input Documents
• PEM-0010.00.00-00010-001-0-0 PEM@B. Braun Guide
This document shall be read in conjunction with;

• PEM-0100.00.00-01N00-001-0-0 Guideline – Project Governance
• PEM-1030.20.00-10B01-001-0-0 Standard – Phase Models & Project Process Maps
• BPP-HC-DIV 2251 - Process Map (Project Process Map for Capacity Expansions and
replacement Investment Projects within Global Process Engineering in CoE
Pharmaceuticals)
• BPP-HC-DIV 1502 - Phase Gate Decision Making in Project Management Board (PMB)
CoE Pharmaceuticals
2 OVERVIEW
This guideline describes how the PEM requirements for Project Governance will be fulfilled for global
projects with different project types, categories and Managed Portfolios in CoE Pharma.
The CoE Pharma Managed Portfolios for global Projects are:

• Product Dev. / F Global Product Development Projects CoE PH
• PLCM / S Global PLCM Projects CoE PH
• Technical / T+U Global Investment Projects to extend/maintain production capacity CoE PH
• Digitalization & Organizational / N+S Global Digitalization & Organizational Projects CoE PH

Title
3 PROJECT GOVERNANCE
3.1 IMPORTANCE OF PROJECT GOVERNANCE

Please refer to PEM Guideline – Project Governance PEM-0100.00.00.-01N00-001-0-0
Project Governance is established at the end of project initiation DI3 phase.
3.2 PROJECT CATEGORIZATION

Project categorization is a means of describing the size of business impact, complexity and risk
associated with the project.
Table 3.1 PEM Requirements for Project Categorization
PEM Requirement Details Valid for Project

Requirement Categories
02.01 Project 1. All projects are categorized in accordance with the A, B, C, D
Categorization standard categorization scorecard (implemented as a
worksheet or on-line system)
2. Project Categorization is used to define management
escalation levels for project planning approval, decision
making & issue / risk escalation
3. Project Categorization is completed as preliminary at
DI1, and finalized by DI2 of the Acquisition Cycle prior to
project Go / No Go decision. At DI3 Project Categorization
is reviewed / confirmed prior to Project Charter Approval.
4. Project Categorization is updated for decision support at
each Phase Gate or in response to any significant change
in project scope, risks or the project environment
Initial categorization takes place in the Project Portfolio process and is documented in the general
PEM-IT management and reporting system.
In all phases before DI3 Portfolio Management Teams (PfMTs) are responsible for categorization.

Title
3.3 PROJECT GOVERNANCE DECISION AUTHORITIES & RESPONSIBILITIES IN COE PH (GLOBAL PROJECTS)
Project Governance decision ‘Authorities’ are individuals, committees or boards that have sufficient
experience, influence and authority within the organization to make decisions which are binding on
the project and the organization.
Table 3.2 PEM Requirements for Project Governance Decision Authorities

02.02 Project 1. Responsibilities of Project Governance Decision A, B, C, D
Governance Authorities (individuals, committees or boards) are defined
Authorities & 2. Project Governance Decision Authorities are required to
Responsibilities have sufficient representation, competence, authority and
resources to enable them to make appropriate decisions
without further consultation with other project stakeholders
3. Project Governance decision authorities are defined at
appropriate levels of management in accordance with the
Project Category
02.02 Project A, B, C, D
4. Project Sponsors are appointed for all projects
Sponsors
02.02 Steering 5. Project Steering Committees are appointed where A, B, C, D
Committees necessary for projects involving cross-functional / cross-
business unit activities
Project Governance decision authorities are defined at appropriate levels of management in

accordance with the Project Category.
Figure 3.1 Project Governance Levels derived from Project Categorization

Title
One project should have maximum two escalation and decision levels.
Projects of category A3, B3, B2, C3, C2, C1 and D are expected to have rather only one escalation
level.
Projects with high business impact and high complexity as B1, A2 and A1 are expected to have rather
two escalation levels depending on the phase gate approvals.
Decisions can be escalated from PG2 to PG1 or from PG1 to PG0. The PG levels are defined in the
Project Governance Plan.
For the CoE Pharma projects types the following definitions for the Project Governance Authority Level
apply:
Table 3.3 Project Governance Authorities per Project Type and Category
Project Type Project Category
A B C D
Global Product PG1: Project Sponsor / PMB Project PG1: Project PG1: Project
Development Management Board (part: Product Sponsor and / or Sponsor
Projects Development Projects) represents PMB
regular decision making authority.
Further escalation (if required) or
particular decisions (for A1, A2, B1) go
to the CoE Pharma Steering (PG0) (to
be defined in Project Governance Plan).
Global Capacity / PG1: Project Sponsor / PMB Project PG1: Project PG1: Project
Investment Management Board (part: Technical Sponsor and / or Sponsor
Projects Projects) represents regular decision PMB
making authority.
to the CoE Pharma Steering (PG0) (to
be defined in Project Governance Plan).
Global PLCM PG1: Project Sponsor / PLCM Board PG1: Project PG1: Project
Projects represents regular decision making Sponsor and / or Sponsor
authority. PLCM
Further escalation (if required) or Operational
particular decisions (for A1, A2, B1) go Steering
to the CoE Pharma Steering (to be
defined in Project Governance Plan).
Global PG1: Project Sponsor / CoE PG1: Project PG1: Project
Digitalization Management Team represents regular Sponsor Sponsor
Projects decision making authority.
to the CoE Pharma Steering (to be
defined in Project Governance Plan).

Title
Table 3.4 Functional Representatives in CoE PH Project Governance Authorities

CoE PH Project Management CoE PH PLCM Board CoE PH Steering
Board (PMB)
• Head of CoE PH • Head of CoE PH • Member of the Board
• Head of Global R&D • Head of Global R&D • Head of CoE PH
Pharmaceuticals Pharmaceuticals • Head of Global Marketing &
• Head of Global Process • Head of Global Regulatory Sales HC
Engineering Affairs • Head of Division Controlling
• Head of Global Regulatory • Head of Global R&D HC & OPM
Affairs Pharmaceuticals • Head of Medical Scientific
• Head of Operations (Region) • Head of Quality Affairs
• Head of Quality Management PH • Head of Quality Management
Management PH • BU Heads (BC, CC) Global HC
• Head of Medical Scientific Marketing & Sales • Head of Strategic Purchasing
Affairs • CoE Controlling HC
• BU Heads (BC, CC) & VPs
Global Marketing & Sales additional as needed:
(BC, CC, Strat. Projects) additional as needed: • BU Heads (BC, CC) & VPs
• CoE Controlling • Head of Operations Global Marketing & Sales
(Region) / Plant Managers (BC, CC, Strat. Proj.)
additional as needed: • Head of Medical Scientific • Head of Global Process
• Head of Procurement Affairs Engineering
• Head of Supply Chain Mgt • VPs Global Marketing & • Head of Global R&D
• Head of GAMA Sales (BC, CC) Pharmaceuticals
• Head of Global Construction • Head of Global Regulatory
Mgt Affairs
• Product Managers Global • Head of Operations (Region)
Marketing & Sales (BC, CC) • Head of Quality Management
PH
• Head of Supply Chain Mgt
Moderation & facilitation: Global Moderation & facilitation: Head Moderation & facilitation: Global
PMO CoE PH of Global PPLCM Mgt CoE PH PMO CoE PH
3.4 PHASE GATE APPROVAL DECISIONS AND PHASE GATE READINESS REVIEWS IN COE PH (GLOBAL
PROJECTS)
Phase Gates are milestones at the end of a project phase at which the project must have important
decisions made by management allowing it to proceed to the next phase. Phase Gates are
milestones, at which a ‘hard stop’ occurs. The project does not proceed past a Phase Gate without a
formal decision being made.
The phase gate process for decision making consists of following key elements:
 Phase Gates are defined for important decision points during the project lifecycle
 Phase Gate decisions are made by the appropriate Project Governance Decision Authority
which are defined in the Project Governance Plan

Title
 Phase Gate decisions are documented in a Phase Gate Approval document or via an on-line
system
 Phase Gate decisions are communicated to appropriate stakeholders
 Phase Gate Readiness Reviews are conducted by the project team prior to Phase Gate
decision making to ensure all information is available to make a decision
 Phase Gates must be approved or given conditional approval (with conditions defined) in order
for the project to proceed to the next phase
Project Decision making follows a structured and predefined Phase Gate Process with defined
stages and decision points during project life cycle.
Phase Gates are milestones at the end of a project phase at which the project must have important
decisions made by management allowing it to proceed to the next phase. Phase Gates are
milestones, at which a ‘hard stop’ occurs. The project does not proceed past a Phase Gate without a
formal decision being made.
Prior to a Phase Gate Approval the Phase Gate Readiness Review has to be performed.
Responsibility for Phase Gate Approvals is defined in the Project Governance plan. Phase Gate
decisions are documented in a Phase Gate Approval document or via an on-line system.
Phase Gate decisions may include:

• Project Go / No-Go
• Investment Decision
• Key technological or solution selection
• Decision on which options or direction to take
• Approval of subsequent development or design strategy based on latest knowledge
Inputs for Phase Gate Approval Decisions focus on but is not limited to
• Outcome of Phase Gate Readiness Review (documented in Phase Gate Approval Readiness
Review document)
• (updated) Project Charter
• (updated) Project Business Case and Profitability
• (updated) Project Risk Register (Top 10 max.)
As a preparation for a Phase Gate Approval the Phase Gate Readiness Review focuses on but is not
limited to
• assessment of the outcome of the last stage
• assessment of associated risks before entering into the next phase
• (re)assessment of project budget and schedule for the next phase(s)
• (re)assessment of project business case and profitability
• assessment if deliverables fulfil the requirements
• fulfilment of all key points of the project type specific process map
For Phase Gate Approval Readiness Reviews and Phase Gate Approval Decisions and following
templates should be used:
Refer to PEM-Template: PEM-0100.00.30-10B10-001-0-0 Phase Gate Approval Readiness Review

Refer to PEM-Template: PEM-0100.00.31-10B10-001-0-0 Phase Gate Approval Decision
For Product Development Projects a particular SOP for Phase Gate Approval Decisions is in place,
see section 3.4.2.

Title
Table 3.5 PEM Requirements for Phase Gate Process

02.03 Phase 1. Phase Gates are defined for important decision points A, B, C, -
Gate Process for during the project lifecycle
decision making -
3. Phase Gate decisions are documented in a Phase Gate
Definition of
Approval document or via an on-line system
Phase Gates
4. Phase Gate decisions are communicated to appropriate
stakeholders
6. Phase Gates must be approved or given conditional
approval (with conditions defined) in order for the project to
proceed to the next phase
02.03 Phase A, B, C, -
Gate Process for 2. Phase Gate decisions are made by the appropriate
decision making - Project Governance Decision Authority which are defined in
Phase Gate the Project Governance Plan
Decision
Authorities
02.03 Phase A, B, C, -
5. Phase Gate Readiness Reviews are conducted by the
Gate Process for
project team prior to Phase Gate decision making to ensure
decision making -
all information is available to make a decision
Phase Gate
Readiness
Reviews

Title
3.4.1 Specific Product Lifecycle for Pharmaceutical Products in CoE PH

Phase Gate approaches for product related projects are driven by the specific phases of the Product Lifecycle.
Figure 3.2 and 3.3 describe the specific product lifecycle Phases for Pharmaceutical Products:
Figure 3.2 Specific Product Lifecycle for Pharmaceutical Products (part 1):
Figure 3.3 Specific Product Lifecycle for Pharmaceutical Products (part 2):
General definitions (see figure 3.4) are in place to differentiate Product Development and Product Modification
(PLCM) activities and therefore the entry points into the lifecycle phases.

Title
Figure 3.4 General Definitions for Product Development and Product Modifications (PLCM):
3.4.2 Phase Gate Approach for Global Product Development Projects:
Phase Gate Approach for 3 repeatable and representative types of Product Development Projects are
described in the following section.
Specific and more detailed information on Phase Gate Decision Making in Project Management Board (PMB)
CoE Pharmaceuticals for Product Development Projects is described the following SOP: BPP HC-DIV 1502.
Refer to IMS SOP:

BPP-HC-DIV 1502 - Phase Gate Decision Making Procedure for Product Development Projects in CoE PH
A. Development of New Drug
Figure 3.5 Overview Phase Gate Process for New Drug Development Projects

Title
Table 3.6 Phase Gate Details for New Drug Development Projects
Phase Gates for Development of New Drug:

Phase Phase Gate Name Result of previous Phase Transition Mandatory
Gate Phase/Approval to Phase
Gate?
G200 Project Charter Project Charter approval Development
(DI3) Approval Concept Definition
Y
& Planning Phase
G210 Development Concept Development Concept & Development &
& Project Base plan Project Base Plan approved Clinical Phase 1
Y
Approval & Ready for (Pre-formulations are tested,
first in human (Clinical characterized and proven
Phase 1) with regards to safety in
order to start Clinical Phase
I. All required data for
IND/IMPD are available.)
G220 or Product Ready for Formulation is tested, Development &
M220 Patients (Clinical characterized and proven Clinical Phase 2
N
Phase 2) with regards to safety in
order to start Clinical Phase
II. All required data for
IND/IMPD are available.
G230 Product Ready for Ensure that formulation is Clinical Phase 3 /
Large Pivotal Studies tested, characterized and Scale-up /
Y
(Clinical Phase 3) proven with regards to safety Regulatory Stability
and efficacy including target Batches
dosage in order to start large
pivotal studies Clinical Phase
III.
Confirm that all required data
for IND/IMPD are available.
Product & Process
Commercial Scale up
completed, manufacturing
process is scaled up and
CPPs confirmed
G300 Ready for Submission Formulation/drug product is Registration &
proven with regards to safety Launch Preparation
Y
and efficacy as well as with
regards to quality in order to
start registration process.
All data necessary for market
authorization application are
available and consistent.
G400 Ready for Launch All requirements for market Launch &
launch are fulfilled and PV/Production Start
Y
routine production set up and up
ready for commercial supply.

Title
G410 Ready for Project 6 months of Hand-over to

(DI4) Close-out commercialization in first routine /
Y
countries and handover to commercial / PLCM
product lifecycle (6 months post
management and launch) and ready
commercial manufacturing for Project Close-
organization completed out (DI5)
B. Development of Generic Drug / Major Reformulation

Figure 3.6 Overview Phase Gate Process for Generic Drug Development Projects
Table 3.7 Phase Gate Details for Generic Drug Development Projects
Phase Gates for Development of Generic Drug / Major Reformulation:

Phase Phase Gate Name Result of previous Phase Transition to Mandator
Gate Phase/Approval y Phase
Gate?
G200 Project Charter Approval Project Charter approval Development
(DI3) Concept Definition &
Y
Planning Phase
G210 Development Concept & Development Concept & Development
Project Base plan Project Base Plan
Y
Approval approved
G220 or Product Ready for Scale Product & Process Lab Scale-up &
M220 up (and Bioequivalence, scale Development Bioequivalence (if
N
if required) completed, product and required)
process design concept is
feasible and confirmed in
lab scale
G300 or Product Ready for Product & Process Pilot Implementation &
M300 Implementation & scale Development TechTransfer
N
TechTransfer completed, bioequivalence
confirmed
G310 Product Ready for Product & Process Regulatory Stability
Regulatory Stability Commercial Scale up batches
Y
Batches completed, formulation
tested, characterized and
proven, manufacturing
process is scaled up and
CPPs confirmed

Title
G320 Ready for Submission Formulation / drug product Registration &

is proven with regards to Launch Preparation
Y
quality in order to start
registration process.
All data necessary for
market authorization
application are available
and consistent.
G400 Ready for Launch All requirements for market Launch & PV/
launch are fulfilled and Production Start up
Y
routine production set up
and ready for commercial
supply
G410 Ready for Project Close- 6 months of Hand-over to routine
(DI4) out commercialization in first / commercial / PLCM
Y
countries and handover to (6 months post
product lifecycle launch) and ready for
management and Project Close-out
commercial manufacturing (DI5)
organization completed
C. Development of New / Next Generation Container / Delivery System
Figure 3.7 Overview Phase Gate Process for New Container System Development Projects
Table 3.8 Phase Gate Details for New Container System Development Projects
Phase Gates for Development of New Container/Delivery System (CS):

Phase Phase Gate Name Result of previous Phase Transition to Mandator
Gate Phase/Approval y Phase
Gate?
G200 Project Charter Approval Project Charter Approval Development
(DI3) Concept Definition & Y
Planning Phase
G210 Development Concept & Development Concept & Detailed Design
Project Baseplan Project Base Plan (Lab)
Y
Approval approved
M220 CS Ready for Product & Process Concept Development &

Title
Development & Scale development (Lab scale) Scale Up (Pilot) N

up (Pilot) Phase completed, product and
process design concept is
feasible and confirmed in
lab scale
G300 CS Ready for Product & Process Pilot Implementation &
Implementation & Development (Pilot Scale) TechTransfer
Y
TechTransfer completed, Design Freeze
for Packaging System (in
Pilot Scale)
G310 Product Ready for Product & Process Regulatory Stability
Regulatory Stability Commercial Scale up batches
Y
Batches completed, packaging
system incl. formulation
tested, characterized and
proven, manufacturing
process scaled up and
CPPs confirmed
G320 Ready for Submission Packaging System incl. Registration &
Formulation / drug product Launch Preparation
Y
is proven with regards to
quality in order to start
registration process.
All data necessary for
market authorization
application are available
and consistent.
G400 Ready for Launch All requirements for market Launch &
launch are fulfilled and PV/Production Start
Y
routine production set up up
and ready for commercial
supply
G410 Ready for Project Close- 6 months of Hand-over to routine
(DI4) out commercialization in first / commercial / PLCM
Y
countries and handover to (6 months post
product lifecycle launch) and ready for
management and Project Close-out
commercial manufacturing (DI5)
organization completed

Title
3.4.3 Phase Gate Approach for Global Product Modification (PLCM) Projects in CoE PH:
Figure 3.8 Overview Phase Gate Process for Product Modification (PLCM) Projects
Table 3.9 Phase Gate Details for Product Modification (PLCM) Projects
Phase Gates for Product Modification (PLCM) Projects:

Phase Phase Gate Name Result of previous Phase Transition to Mandatory
Gate Phase/Approval Phase Gate?
G420 Gap/Root cause Project Charter approval Gap / Root Cause
(DI3) analysis Analysis Y
G430 Ready for Product Remediation plan/proposal Product Modification
(DI4) modification of product modification
Y
approved
M440 Ready for Laboratory or scale up Regulatory Stability
Regulatory Stability activities completed / Risk- Batches
N
batches benefit assessment
(if applicable)
approved
G450 Variations of Product modification Variations of Dossier
dossier / Approval activities completed and (RMF) / Approval from
Y
from MoH documents effective / MoH
approval info from MoH
(if applicable)
received
G460 or RMF update & Update RMF after MoH RMF Update &
M460 implementation / approval, ChC activities Implementation /
N
Manufacturing of completed / Readiness to Manufacturing of
modified product continue manufacturing modified product (ChC)
modified drug product
G470 or Ready for routine Project Close-out Approval Hand-over to routine /
M470 commercial and handover commercial commercial production
N
(DI4) production activities production and ready for Project
Close-out (DI5)

Title
3.4.4 Phase Gate Approach for Global Technical Projects in CoE PH:
Phase Gate Approach for two repeatable and representative types of Technical Projects:
A. Capacity Expansions and Replacement Investments

Figure 3.9 Overview Phase Gate Process for Capacity Expansions & Replacement Investment Projects
Projects
Project Type: Capacity Expansions & Replacement Investment Projects
DI1 DI2 DI3 DI4 DI5
Feasibility Phase Conceptual Design Phase Basic Design Phase Detailed Design Phase Realization Phase Start-Up & Handover
Initiation Close-out
T10 T11 T20 T21 T30 T31
M100 G110 M200 M210 G300 G310 M400
Table 3.10 Phase Gate Details Capacity Expansions & Replacement Investment Projects
Phase Gates for Capacity Expansions and Replacement Investment Projects:

Gate Phase/Approval Phase Gate?
M100 Feasibility start Project approval – Start of Feasibility Phase N
Feasibility
G110 Feasibility approval, Feasibility approval Conceptual Design Y

Concept start Phase
M200 Concept approval, Conceptual Design Basic Design Phase N

Basic Design start approved;
released for Basic Design
M210 Basic Design Basic Design approved; Detailed Design Phase N
approval, Detailed released for Detailed
Design start Design
G300 Detailed Design Detailed Design approved; Realization Phase Y
approval, Realization released for Realization
start
M310 Site acceptance test Acceptance of Equipment Start-up & Handover N
finished, Handover to and Process – Guidance
Operations Handover to Operations
M400 Start of commercial Project Close-out approval Phase-out N
production

Title
B. Construction Projects
Figure 3.10 Overview Phase Gate Process for Construction Projects

Project Type: Global Construction Projects
DI1 DI2 DI3 DI4 DI5
Feasibility Phase Conceptual Design Phase Basic Design Phase Detailed Design Phase Construction & Commissioning Operation & Maintenance
Initiation Close-out
U10 U11 U20 U21 Phase U30 Phase U31
M100 G110 M200 M210 G300 G310 M400
Table 3.11 Phase Gate Details Construction Projects
Phase Gates for Global Construction Projects:

Gate Phase/Approval Phase
Gate?
M100 Feasibility start Project approval – Start of Feasibility Phase N
Feasibility
G110 Feasibility approval, Feasibility approval Conceptual Design Phase Y

Concept start
M200 Concept approval, Conceptual Design Basic Design Phase N

Basic Design start approved;
released for Basic Design
M210 Basic Design Basic Design approved; Detailed Design Phase N
approval, Detailed released for Detailed
Design start Design
G300 Detailed Design Detailed Design approved; Construction & Y
approval, released for Construction Commissioning Phase
Construction start
M310 Construction Acceptance Construction – Operation & Maintenance N
acceptance, Guidance Handover to Phase
Handover to Operations
Operations
M400 Building usage Project Close-out approval Phase-out N

Title
3.4.5 Global Digitalization Projects:
A. Project Type: Track & Trace Projects
Figure 3.11 Overview Phase Gate Process for Track & Trace Projects
Table 3.12 Phase Gate Details Track & Trace Projects
Phase Gates for Track & Trace Projects:

Gate Phase/Approval Phase
Gate?
G100 Project Charter Project and Budget Gap Analysis Y
Approval approved; Final Technical
(DI3)
Spec. released by MoH
M200 Gap-Fit Analysis Gaps to the existing T&T Process Design N

global processes and IT
architecture identified
M210 URS URS / Overall System Supplier Assessment N
Specification
G300 Contract Supplier, Equipment and/or Equipment & Solutions Y
Service Provider contracted Implementation
M310 L1-L3 Qualification Equipment qualified and L1-L5 Process integration N
individual sub-processes
implemented
M320 Overall L1-L5 All processes at global and Serialization / Aggregation N
Processes Validated local levels are validated / Reporting Start-up
G400 Legislation Deadline Regular operations: Close-out Y
Serialization, Aggregation
(DI4) Hyper-care
and Authority Reporting
B. Project Type: Other Digitalization Projects

Section will be added later.

Title
3.5 PROJECT GOVERNANCE PLAN
Table 3.13 PEM Requirements for Project Governance Plan

02.07 Project 1. A Project Governance Plan is defined which identifies A, B, -
Governance plan appropriate Project Governance & Corporate Governance
decision authorities for each project Phase Gate and for
issue / risk escalation in general
2. The Project Governance Plan incorporates a RACI matrix
identifying other parties to be informed or consulted at each
Phase Gate
3. Project Report Types and recipients are defined
02.07 Project 4. Project Governance plan optional -, C, D
Governance plan
The Project Governance Plan defines;

• The person, committee or board exercising Project Governance Authority at each of the
levels required for the Project Category
• The decision authorities related to Corporate Governance for Investment Approval
• Project Reporting requirements
• Decision making authorities at Phase Gates
• The role of other parties involved in the project
Refer to PEM-0100.00.10-01N02-001-0-0 Project Governance Plan
Blue prints of Project Governance Plans for the different project types (Project category A&B) are
available:
− Global Product Development Projects CoE PH: refer to Appendix 1

PEM-0100.00.02-01N00-001-PH-0
− Global Product Modification PLCM Projects CoE PH: refer to Appendix 2
PEM-0100.00.03-01N00-001-PH-0
− Global Capacity Expansions and Replacement Investment Projects / Global Construction
Projects: refer to Appendix 3
PEM-0100.00.04-01N00-001-PH-0
− Global Digitalization Projects: refer to Appendix 4
PEM-0100.00.05-01N00-001-PH-0
Gates / Milestones are agreed between PM and Project Sponsor for the individual project and
documented in the Project Governance Plan for the Project at DI3.

Title
3.6 PERIODIC PROJECT (PERFORMANCE) REVIEWS BY MANAGEMENT

Table 3.14 PEM Requirements for Periodic Project Reviews by Management
PEM Requirement Details Valid for

Requirement Project
Categories
02.04 Periodic 1. Periodic project (performance) reviews are conducted by A, B, -
Project Reviews management to assess project progress, foster frank
by Management - internal disclosure of project information, deal with issues &
Set up and ensure adequate support for project success
frequency
2. The Project Governance Authority level required to
participate in project performance reviews is determined by
the Project Category
3. The frequency of project reviews is defined in the Project
Governance Plan
5. Management decide when independent scrutiny of
projects and project management systems is required, and
implement such scrutiny accordingly"
02.04 Periodic A, B, -
4. Project Reviews are recorded and communicated to
Project Reviews
appropriate stakeholders
by Management -
Recording and
communication
02.04 Periodic 6. Management reviews may be limited to high priority and / -, C, D
Project Reviews or selected projects based on ‘traffic lights’ signaling issues
by Management requiring attention
3.6.1 Regular Monthly Project Review Meetings (within regular PG meetings)
Periodic project (performance) reviews are conducted by the defined project governance authority to
assess project progress, foster frank internal disclosure of project information, deal with issues &
ensure adequate support for project success.
Project performance reviews are administered and supported by the responsible for moderation and
facilitation of the according project governance committee (see table 3.4) and are part of the regular
PG meetings.
Input for periodic project (performance) reviews are standardized project performance measures
provided in standard project reports and the standard Project Dashboard via PEM IT.
The Project Manager is responsible to monitor and maintain the project related data in the PEM IT
system on a regular base to ensure that input data for project reviews by the according project
governance authority are correct and up-to-date.
The Project Dashboard Traffic Light format (see table 3.15) is used as input for regular monthly
standard reporting to the project governance authorities.
In general the Project Dashboard is presented by the responsible for moderation and facilitation of the
according project governance committee (see table 3.4).

Title
The project manager is expected to show up and participate to the regular project review meetings in
case:
- a red traffic light is set for the project (PM to provide info on countermeasures, options, support
required)
- a decision is required (PM to present options and recommendations for decision making)
Table 3.15 Standard Project Dashboard Traffic Lights for Monthly Reporting
Traffic Light Description

Project Status Indicates overall Project status
Cost Status Linked to Estimate at Completion : indicates budget compliance
Schedule Status Linked to Milestone Trend Analysis : indicates schedule compliance
Deliverable Status General indicator of project deliverables meeting intended purpose
(Quality)
Risk Status Indicator of high or changed risks
Resource Status Indicator of resource availability & performance
Required Decisions Indicator that the project requires a decision by management
3.6.2 Extended Project Performance Review Meetings for Category A Projects

With focus on Projects of Project Category A approx. twice a year more detailed Project Performance
Reviews are executed focusing on the assessment of project performance based on further standard
KPIs like:
• Milestone Performance
(via MTA – Milestone Trend Analysis, provides an easily visualized high level schedule
overview of key milestones, rising trend indicates slipping schedule)
• EAC: Estimate at Completion
(provides a complete cost overview, including: Approved budget adjusted with Approved
Changes, costs as shown in SAP, estimated costs to complete the project, probability
weighted Prospective Changes, remaining Provisional Sums, remaining Contingencies & Risk
Reserve)

Title
• Project Risk Level and Residual Risk

(Risk value is a monetarized estimate of probability weighted project risks. The project should
work to minimize & eventually eliminate residual risk)
• Number and % Changes & source of Changes
(The % change in costs due to Changes is a measure of the quality of previous works e.g.
completeness of design, quality of contracts; Analysis of the source of Changes provides
insight into problem areas such as scope management, incomplete / incorrect design inputs
etc.)
These extended project performance reviews are administered and supported by the responsible for
moderation and facilitation of the according project governance committee (see table 3.4) and are
part of the regular PG meetings.
The project manager participates to these extended Project Performance Reviews and is expected
to prepare and present the inputs and KPIs.
3.7 PROJECT MANAGER APPOINTMENT & LIMIT OF AUTHORITY

Table 3.16 PEM Requirements for Project Manager Appointment, Authorization & Release

1. The Project Manager is formally appointed to manage a A, B, -
project via a Project Manager Appointment Letter which
authorizes the Project Manager to act on behalf of the
company within the scope and for the duration of the project
2. Taking into account the Project Category and types of
02.06 Project
contract partners involved, project specific Limits of
Manager
Authority for commercial and contract matters are defined
Appointment,
Authorization & 3. The General Rights & Obligations of the Project Manager
Release within the organization are defined in a standard document
4. The Project Manager is released at the conclusion of the
project via a Project Manager Release Letter, or
automatically at a specified point in the project as defined in
the appointment letter
02.06 Project 5. Generally managed through the operative signature -, C, D

Manager rights of line management
Appointment,
Authorization &
Release
A common blueprint of PM Appointment Letter is available for all project types (Project category
A&B): refer to Appendix 5: PEM-0100.00.06-01N00-001-PH-0
It has to be adapted to individual project and specific needs accordingly.
PM release will be handled with project closeout report at DI5.

Title
4 APPENDICES TO THE GUIDELINE

Appendix 1: Blueprint Project Governance Plan for Global Product Development Projects in CoE PH
PEM-0100.00.02-01N00-001-PH-0
Appendix 2: Blueprint Project Governance Plan for Global Product Modification PLCM Projects CoE PH,
PEM-0100.00.03-01N00-001-PH-0
Appendix 3: Blueprint Project Governance Plan for Global Capacity Expansions and Replacement Investment
Projects / Global Construction Projects in CoE PH,
PEM-0100.00.04-01N00-001-PH-0
Appendix 4: Blueprint Project Governance Plan for Global Digitalization Projects in CoE PH,
PEM-0100.00.05-01N00-001-PH-0
Appendix 5: Blueprint PM Appointment Letter for Global Projects in CoE PH,
PEM-0100.00.06-01N00-001-PH-0

Title
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1.0 2021-03-15 First Issue I. Stabl
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Guideline - Project Governance for Global Projects in CoE Pharma

Business area HC-PH

Management of this Document

Irene Stabl Digital unterschrieben

Juan Gil Béjar Digitally signed

Rildo Feirrera-Campos Digital

CKN 110 - Project Governance

CKN 110 - Project Governance

CKN 110 - Project Governance

1.1 DOCUMENT OWNERSHIP & AUTHORITY

1.2 PURPOSE & SCOPE

1.3 RELATIONSHIP TO OTHER DOCUMENTS

This document shall be read in conjunction with;

The CoE Pharma Managed Portfolios for global Projects are:

CKN 110 - Project Governance

3.1 IMPORTANCE OF PROJECT GOVERNANCE

3.2 PROJECT CATEGORIZATION

Table 3.1 PEM Requirements for Project Categorization

PEM Requirement Details Valid for Project

CKN 110 - Project Governance

Table 3.2 PEM Requirements for Project Governance Decision Authorities

Project Governance decision authorities are defined at appropriate levels of management in

Figure 3.1 Project Governance Levels derived from Project Categorization

CKN 110 - Project Governance

CKN 110 - Project Governance

Table 3.4 Functional Representatives in CoE PH Project Governance Authorities

CKN 110 - Project Governance

Phase Gate decisions may include:

Refer to PEM-Template: PEM-0100.00.30-10B10-001-0-0 Phase Gate Approval Readiness Review

CKN 110 - Project Governance

Table 3.5 PEM Requirements for Phase Gate Process

CKN 110 - Project Governance

3.4.1 Specific Product Lifecycle for Pharmaceutical Products in CoE PH

CKN 110 - Project Governance

3.4.2 Phase Gate Approach for Global Product Development Projects:

Refer to IMS SOP:

A. Development of New Drug

CKN 110 - Project Governance

Phase Gates for Development of New Drug:

CKN 110 - Project Governance

G410 Ready for Project 6 months of Hand-over to

B. Development of Generic Drug / Major Reformulation

Phase Gates for Development of Generic Drug / Major Reformulation:

CKN 110 - Project Governance

G320 Ready for Submission Formulation / drug product Registration &

C. Development of New / Next Generation Container / Delivery System

Phase Gates for Development of New Container/Delivery System (CS):

CKN 110 - Project Governance

Development & Scale development (Lab scale) Scale Up (Pilot) N

CKN 110 - Project Governance

Phase Gates for Product Modification (PLCM) Projects:

CKN 110 - Project Governance

A. Capacity Expansions and Replacement Investments

DI1 DI2 DI3 DI4 DI5

M100 G110 M200 M210 G300 G310 M400

Phase Gates for Capacity Expansions and Replacement Investment Projects:

G110 Feasibility approval, Feasibility approval Conceptual Design Y

M200 Concept approval, Conceptual Design Basic Design Phase N

CKN 110 - Project Governance

Figure 3.10 Overview Phase Gate Process for Construction Projects

DI1 DI2 DI3 DI4 DI5

M100 G110 M200 M210 G300 G310 M400