Case Studies in Pharmaceutical Project Management - Pharmaceutical Technology

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PharmTech Europe

Case Studies in Pharmaceutical Project Management
A technical forum featuring Catalent Pharma Solutions, SAFC, and Neuland Laboratories.

Pharmaceutical Technology
Volume 36, Issue 2, pp. s14-s22

Real-time project management

Saharsh Rao Davuluri, president of contract research at Neuland Laboratories

On-time execution of API project development is a challenge for manufacturers. Neuland Laboratories has designed its GuarD project-management system around the principles of critical chain project management (CCPM), a concept developed by Eliyahu Goldratt, a prominent management consultant, who introduced the theory of constraints business model. Unlike other project-management systems, CCPM emphasizes flexible start dates and shared project resources. CCPM also uses buffers as a shared project resource rather than an individual task resource, thus enabling the overall project to be completed on time without requiring the individual tasks to be completed on time.

Figure 1: (Neuland). A screenshot illustrating how a project’s progress can be tracked and how a user can participate directly through the GuarD web portal. (FIGURE 1 (NEULAND) IS COURTESY OF THE AUTHOR)
Process and organization. Neuland is an API and contract manufacturer based in Hyderabad, India. Almost 80% of the company's products are sold into the US and European markets, and these product must meet strict regulatory standards. In a typical year, Neuland scientists complete 30–40 projects ranging from complete API development, production of starting materials, and development of alternate processes for new molecular or chemical entities, as well as a variety of contract-manufacturing assignments for pharmaceutical ingredients and peptides. Depending on their complexity, projects may require process chemistry, analytical chemistry, technology transfer, production, developmental quality assurance, supply-chain management, regulatory affairs support, and project-management services.

Organizational framework and real-time monitoring. Under GuarD's CCPM approach, each project is broken down into its basic tasks by a cross-functional team. The project has a designated team leader, usually an experienced scientist from the process-chemistry department, and a project manager responsible for managing timelines and communications. The team leader is the technical head of the project and responsible for overall execution.

Once the project has been divided into the basic tasks and sub-tasks, the details are transferred to a Microsoft project software template. This ensures that all the dependencies, resource requirements, and tentative start and end dates are recorded. The project is not considered "live" until the cross-functional team signs off on the detailed project plan. The finalized project document is uploaded to a web portal, and managers update respective tasks and sub-tasks as the project progresses. Managers can make qualitative updates detailing how tasks are proceeding, or quantitative updates to help respective task managers track how long a task will take to complete. Teams are encouraged to make at least one status update per day.

The ability to make both qualitative and quantitative updates in the GuarD project-management system is highly useful. Personnel in downstream operations, and more importantly the client, get an accurate picture of progress upstream and can plan accordingly. Neuland's customers also can track a project's progress and participate directly through the GuarD web portal.

Benefits. A key advantage of the GuarD system is that its detail and interactive nature make it easier to promptly identify and manage delays at any step, thereby facilitating on-time completion. For example, when the process-chemistry department requires more time to complete their tasks, the project manager is immediately aware of the situation and can work with all task managers to identify opportunities downstream to recover that time. Although it is important for the project manager to investigate the reasons for the delay, the immediate focus is on finding ways to deliver a quality project on time. Solutions might include running additional shifts or vessels or staggering batches. In most cases, customers are invited to join these discussions and contribute to the solution based on their experience and priorities.

Customer trends: biopharmaceutical companies
Neuland's project-management system helps its clients in several ways. It provides a platform of almost 100% transparency, providing more insight than weekly calls or project reports. A smart phone app will soon allow customers to access their projects real-time. It also enables higher on-time completion rates. Although the GuarD approach cannot promise 100% on-time completion, it has enabled Neuland to make considerable progress towards this goal.


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