Letter from Managing Director, PMI India   |   Download a PDF version     
Cover Story  
By Invitation  
Article of the  
month  
Chapter News  
Champion Update  

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 countries.

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.

Recommendations

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.

Recommendations

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 circumstances.

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.)
back to top  back to top

© 2014 Project Management Institute, Inc. Brought to you by CyberMedia Services.


PMI Organization Center Private Limited
302-305, III Floor, Balarama, Plot No. C-3, E Block, Bandra Kurla Complex, Bandra (E), Mumbai, India 400 051
Phone: +91 22 2659 8659, Fax: +91 22 2659 2235.     www.pmi.org

"PMI", the PMI logo, "Making project management indispensable for business results", "PMI Today", "PMI Network", "Project Management Journal", "PMBOK", "CAPM", "Certified Associate in Project Management (CAPM)", "PMP", "Project management Professional (PMP)", the PMP logo, "PgMP", "Program Management Professional (PgMP)", "PMI-SP", "PMI Scheduling Professional (PMI-SP)", "PMI-RMP", "PMI Risk management Professional (PMI-RMP)", "OPM3", "PMI-ACP", "PMI Agile Certified Practitioner (PMI-ACP)", the PMI Educational Foundation logo and "Empowering the future of project management" are marks of Project management institute, Inc.

For a comprehensive list of PMI marks, contact the PMI Legal Department.