Management of a

pharmaceutical project
Introduction
The practice of Project Management within the highly
regulated world of the pharmaceutical industry provides
unique challenges and opportunities. It is considered
good project management practice to integrate GxP
with relevant project management activities to ensure
that compliance risk is managed effectively and
proactively
provide guidance for Project Managers and other
professionals who are involved in projects in the
pharmaceutical industry
integration of risk management into specific aspects of
a project
Typical Pharmaceutical Drug Product Life
Cycle and the Scope of project management
Typical Project Life Cycle
Project Types
These project types could include:
Facility
New and Retrofit Facilities
New Equipment or Equipment Systems
Improvement
Product, Facility, and Equipment
Audit (Safety or Quality) Preparation and subsequent improvement (typically
linked to a facility)
Product
New Product and Product Transfer
Technology Transfer
IT
ERP Implementation
Typical Project Stage Gate
Approach
People Management
Roles and Responsibilities:
1. The Project Manager
Project Managers should manage communication,
knowledge transfer, project goals, and maintain a
conflict-free project delivery.
Project Management Capability:
Project Managers may need to coordinate a wide range of knowledge in
pharmaceutical industry projects and may not be a Subject Matter
Experts (SME) for the project type. Project Managers usually require the
ability to ask the correct questions and to respond to those questions
appropriately, by having an understanding of:
how to deliver successful projects in this highly regulated industry
the challenge of science driven projects
 Knowledge:
Has knowledge of the regulatory context in which a project is to be delivered.
Has knowledge of the project type in terms of the typical life cycle, risks, and
key success criteria.
Has knowledge of the critical pharmaceutical processes or technologies that
constitute a large part of the project
Understands how to engage with people.
Skills:
Able to manage at all levels throughout the organization with strong
communication skills and good political and cultural awareness.
Possesses appropriate project management skills:
Possesses appropriate leadership skills, e.g., thinking strategically, resolving
conflict, and managing key business relationships.
RACI Chart
R = Responsible who does the work to complete an
activity or task
A = Accountable who is ultimately accountable for the
correct completion of the activity or task
C = Consulted whose opinion is sought during the
completion of the task
I = Informed who is kept up to date about the progress
of a task and/or its completion