Project Management in Capital Projects in Pharmaceutical Industry
BY DIPEN SHROFF, PMP
In India, the growth and achievements of the pharmaceutical
industry in the past five decades have been phenomenal
and rated as one of the highest among developing
The pharmaceutical industry carries out a wide range of activities
as projects such as drug discovery, novel process for manufacturing existing products, drug delivery, and new technologies. In the case of bulk drugs or Active Pharmaceutical
Ingredients (API) industry, market projections or existing
requirements, backed by market research, trigger new projects. Based on this information, a pharmaceutical company’s
management takes a decision to go for a new manufacturing
facility within an existing plant (brown field) or at a new site (green field).
Summary of Project Activities
In the pharmaceutical industry, the below activities are covered
elaborately under the qualification and validation phase: Requirements for a new project are finalized by representatives
from various functions and the project team, who then work in close coordination with the purchase team for finalization
of contractors and material/equipment suppliers, and supply timelines. The execution phase is the most important phase that ends with commissioning of the plant and equipment trials. The project department, along with the cross-function team, checks the facility and equipment to confirm if the performance is as per the design intent.
Lesson Learned 1
One of the most commonly encountered problems during a pharmaceutical project is when the product or process by which it was to be manufactured undergoes change. This change may appear simple but it may pose a major challenge.
In this situation, the project and process engineering team tries to fit changed requirements in the plant that is partially erected.
Accommodating new products or changed process that was not the part of the original plan may require major changes
in the design of the project itself.
In project management terminology, this type of a change is called scope change that leads to change in project baselines. Sometimes even after the changes, the plant may not be suitable for production and the project may fail or get scrapped.
A major reason for failure is that a project is conceptualized on one specific product and its process. Rather than basing a project
on a single product or process, conceptualize a multi-product
plant with all the necessary equipment and systems for carrying out basic operations. If a different set of equipment is required for a group of products, change or eliminate that one group of products that will not impact the project so as to make it unviable.
This may increase the cost of the project marginally but will provide flexibility in changing products without compromising
the quality, regulatory, or safety aspects, and the plant can run viably for many years.
Lesson Learned 2
Sometimes due to financial constraints, during planning or execution
phase, management may decide to implement the project
in stages or phases. It may decide to initially construct one or two production blocks with all required ancillary facilities and keep the remaining production blocks for the second phase.
Due to various reasons, the second phase may not materialize. In this scenario, the capacity of the ancillary facilities crosses the reduced requirement. This can lead to an increase in overhead
and high operational costs that makes the product non-viable. Running these equipment and systems at a lower capacity
may not give an efficient output or damage the equipment. The higher utility cost may add to the product manufacturing cost.
As a prudent design, it is always good to opt for modular construction
of utilities and ancillaries, or even decentralized facilities.
The second option may result in a slightly higher manpower
cost to operate it but will provide the flexibility in facing waxing and waning production schedules due to unforeseen
There are many such lessons to be learned in pharmaceutical projects. To eliminate or reduce the risks of new projects, project
managers must collect lessons learned across the organization
to create a rich repository for new project managers to utilize.
(He has over 13 years of experience in the field of project management and production in the API industry. Currently, he is working with one of the top-most pharmaceutical companies in India.)