There are many elements of project management that are generic across both project and industry types; however, there are some specific challenges within the pharmaceutical industry. The ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry (PM GPG) was developed to address those challenges with certain key aims in mind (1). This formed the basis of the business case, which further detailed key objectives.
The first objective was to create a document to discuss and compile best practices for project-management concepts within the context of the pharmaceutical industry, which has unique needs and challenges. The second aim was to have the PM GPG serve as a toolkit to help pharmaceutical project managers deliver successful projects quickly. The developers set out to offer content that addresses managing risks common to pharmaceutical projects and to promote and support a common language for the pharmaceutical project-management community.
Once the business case for the guide gained ISPE approval, the project for developing the guide began. A project director and project manager were appointed, and a team of key stakeholders was formed. The team developed a vision of success for the project.
With this key structure in place, the core team agreed that for the team to achieve success, all had to behave as "good practice" project managers. The team had to use its combined project-management expertise to deliver quality content in an effective, value-added way. The fundamental philosophy driving the delivery was summarized in one phrase: "practice what we preach." In other words, the team needed to use good practice in project management throughout the guide project. The development of a robust project delivery plan (PDP), therefore, was a key requirement.
A PDP requires a project team to fully consider all elements of project delivery before actually starting to deliver the project. For example, in the PM GPG project, the PDP allowed the team to consider its strategy for stakeholder management before making any announcement requiring writers or reviewers involvement.
The approach to managing stakeholders involved working as a small core team to develop the guide structure and key concepts. Involvement of subject-matter experts (SMEs) was requested so that small chapter teams could be formed, each led by a member of the core team. A schedule was developed based on the agreed-on stage gates, and milestones were used to review progress with each chapter team.
In this way, the guide team avoided the usual collaborative document development process of starting with too many eager volunteers who slowly decline to be the active team of writers. In order to effectively engage the industry, the team needed to develop the guide quickly and in a lean manner. Those wanting to get involved, but without the time, were encouraged to get involved in the industry review, a crucial aspect of the whole process.