Abstract
A standard practice when qualifying a pharmaceutical Contract Manufacturing Organization (CMO) to complete work includes conducting an on-site quality audit. In the pharmaceutical manufacturing field, the quality audit is also designed to assure compliance with agencies such as the Federal Drug Administration (FDA) or the European Medicines Agency ( EMEA). During a routine quality audit, the core systems used for operation and control are examined to gain assurance that the CMO will successfully complete the contracted work. Although a quality audit may demonstrate that a CMO is compliant with regulatory requirements, the CMO may not be able to successfully meet project goals due to a less than effective project management system. A functional project management office (PMO) is a valuable core system that enables projects to proceed smoothly, offers client liaison, provides a mechanism for collaboration, and promotes mentoring within a facility.
A facility audit, which includes an assessment of the PMO, would explore the applications and systems used to facilitate project success. Specific to pharmaceutical manufacturing, this would include an assessment of communications not only within and between project teams, their management, and stakeholders, but also with regulatory agencies. Each part of the multidisciplinary team is required to adhere to guidelines specific to the pharmaceutical industry. As such, an evaluation of the systems that govern the project management responsibilities in the CMO could be considered a necessary part of the audit process. A Guide to the Project Management Body of Knowledge (PMBOK® Guide) offers guidance into the industry’s best practices; applying these practices and assembling an appropriate system of project management for a CMO would form a solid foundation and would stand up to such an audit.
Introduction
This paper focuses on the steps a PMO would take to assemble existing systems into an auditable format, which would allow an auditor to determine if the PMO was appropriately equipped to deal with the project management demands of a complex pharmaceutical process transfer and other project types handled by the PMO. This analysis will enable project managers to critically examine gaps within their own departments and to seek improvement, whether or not there is an impending potential for an audit.
The application of PMBOK® Guide practices to your pharmaceutical CMO PMO will help your organization:
- Gain an appreciation of systems, which enable excellence in project and program management in the pharmaceutical industry
- Gain an understanding of your own systems and the gaps that may exist
- Gain an understanding of how to evaluate project management systems at a CMO
- See which project management attributes are unique to the pharmaceutical industry.
A Foundation for Creating the Ideal Pharmaceutical PMO
Part of the responsibility of a high-functioning PMO is to identify and address the aspects of the PMBOK® Guide, which apply to each type of project handled within the department. The PMBOK® Guide spans a breadth of knowledge, which can be applied to all project management, whether the focus is on contract, capital, IT/IS, lean, process improvement, or finance projects. Part of the impact the PMO has on the group is to develop internal systems to enable competent management of any type of project that is routinely handled within the group.
Pharmaceutical project management may come in at several phases and may include program management practices. There may be a program or project that handles the development stage of a new drug substance, the varying phases of clinical trial manufacturing, the launch of commercial products, and, finally, the movement to routine commercial production. Project management for pharmaceutical projects must include multidisciplinary teams and has a heavy need for recognizing complex interdependencies on the demands of other projects and often other facilities.
Having systems in place, which address the predicted pitfalls in the progress of a pharmaceutical project, enhances the opportunity for success; the overall success depends heavily on the integration of individual successes.
Finding the Meaning in the PMBOK® Guide
Sound organizations utilize written project management guidelines (PMGs) to provide consistent application of best practices to better ensure dependable project success. As one initially delves into the PMBOK® Guide, it becomes apparent that it is no small feat to comprehensively apply its contents to organizational project management objectives. Each industry and project type will fully utilize only a subset of the guidelines given in the PMBOK® Guide. Distilling and organizing the contents into a sound set of PMGs applicable to a pharmaceutical CMO is a challenging endeavor; however, with patience, focus, and a clear understanding of PMBOK® Guide organization, one can assess the applicability of each Process Group as it intersects with respective Knowledge Areas and associated Processes.
The Intersection of the Pharmaceutical Contract Manufacturing and the PMBOK® Guide
Although pharmaceutical CMO projects do vary in complexity, the inputs, outputs, and completion goals are aligned. The essence of a pharmaceutical project involves converting an active ingredient into a usable drug product via manufacturing; in the paternal pharmaceutical business, this includes considerable attention to the safety aspects unique to products intended for injection. This aligns well with the need to develop PMGs. Several Knowledge Areas are specific to the pharmaceutical industry; refer to Exhibit 1 for the Knowledge Areas and Process Groups that are impacted and will be addressed. Simply, one assesses each process as it applies to the organization’s requirements and puts it into practice via the PMGs.
Exhibit 1 - Systems for enabling project success, by Process Group
Development of an overall set of guidelines for project management is a contributing factor to the success of a project; however, perhaps even more critical is the need for systems for carrying the project through each phase into completion. In the same way that a CMO client project has unique factors to address to cultivate success, each phase of that project is carried forward by applying best practices and developing appropriate tools. Understanding these needs, developing tools, and implementing systems to propel the project are the keys to success.
For the purpose of this discussion, the first assumption is that the project selection has occurred prior to introduction to the PMO. This is typical of the operation of some CMO operations, as the business is normally aligned with standard project risk practices. The next assumption is that the client has already assembled an appropriate team to handle the technical transfer. Therefore, the initiation process group is largely involved with the identification and assembly of the project team at the CMO, based upon the needs identified during project selection and the development of the preliminary scope document.
A consideration in forming the guidelines to address the pharmaceutical industry in particular is that drug product projects have an over-arching “triple constraint.” Each product must have demonstrated quality, safety, and efficacy. Due to these constraints, there is an even greater need for the PMO to adapt a system that enables and keeps on track a smooth technical transfer with these considerations in mind. Capital support and regulatory requirements are parts of the consideration; purchased capital equipment must conform to guidelines suitable for use in the industry, and the regulatory agencies are expected to audit all aspects of the technical transfer.
Applying the Process Groups and Creating a System
The PMG development process is probably best demonstrated via an example from one of the triple constraint Knowledge Areas. The scope Knowledge Area intersects with the Initiating and Planning Process Groups, presenting the requirement to address scope definition at this phase. Scope definition involves identifying and describing all project deliverables and associated activities. For similar projects, such as those common to a pharmaceutical CMO, a project scope template can be developed that is applicable to virtually all client projects. Effective pharmaceutical CMO project teams require project team participation from all functional areas (manufacturing, planning, regulatory, quality assurance, quality control, engineering, and validation); a possible template is shown in Exhibit 2.
Exhibit 2 – Scope Template
The Communication Knowledge Area also intersects with the Planning Process Group. This critical intersection aids in points of contact for all phases of the project, including those with the direct team members, management, stakeholders, and sponsors. Adapting a system at this intersection is useful for handling all activity Knowledge Areas, resource planning and risk management. Because client-based CMO projects typically have similarly-staffed teams, consistent communication requirements for management, sponsors and stakeholders, and common risks for project completion, one template may be developed to address several intersections at once.
Unique to the pharmaceutical industry, there are some common activities in the Execution Process Group focused on project quality, which can be rolled into a system. The pharmaceutical industry is partially defined by the fact that each product is considered unique; regardless of the fact that a CMO may have performed identical manufacturing activities on another product all technical aspects must be validated. In addition, for parenteral manufacturing, the activities must include sterility and environmental assurance for safety. Therefore, a system of preparation for known activities and for tracking those activities aids in propelling the project toward the next phase. An example of a knowledge management template is shown in Exhibit 3 below. This form is initiated during the execution phase and this is carried forward through project closure and maintained during the product lifecycle.
Exhibit 3 - Knowledge management
During the Monitoring and Controlling Process Group, the main systems used to assure CMO project management success are the continuing use of the project schedule, scope, and knowledge management documents. Of note for the pharmaceutical industry, it is acceptable for the schedule and scope to exceed initial understanding, as long as it’s controlled. Utilizing the systems described above, capturing scope changes with the scope change revision history will assure that the project is in control. The knowledge management document is used in this phase to track any and all deviations, excursions, and project impact occurrences.
Creating the Tools
It is necessary to develop tools that enable the PMO to best apply the identified PMBOK® Guide Processes into a cohesive PMG system. For example, as demonstrated in the preceding section, a project scope template is utilized to develop project scope in a standard way, such that all CMO project managers have a system to identify expected scope and to add scope as needed. To be effective, this scope documentation system should include approvals by both the CMO and client management. Additionally, a document to facilitate scope change needs to be implemented. In this way, added (or removed) scope is tracked and appropriately handled from a logistic and business perspective. Fundamentally, tools are required to ensure triple constraint Knowledge Areas (scope, cost, schedule) are under control.
Another significant tool is required to ensure that the project is well documented and communication is consistent among project managers. This tool can be described as the action item spreadsheet, for which software such as Microsoft Excel is ideal. An example of such a tool is shown in Exhibit 4. Its principle components include a description of the action item, the individual responsible for the action, the due date, and the current status of the action. This communication tool keeps track of the action and also can be used to archive the history. In addition, data sheets can be maintained within the same principle spreadsheet to include a risk register, document tracking, team participation, and other salient project team tracking. Regardless of your role on the team, this communication tool is one central location to receive levels of detail as needed.
Exhibit 4 - Action Item Spreadsheet
Pharmaceutical products that are handled within a CMO may be at the development phase, clinical trial phase, commercial product phase, routine production or transitioning to generic production. Regardless of the phase of the product, the product life cycle comes into play for project management. Despite the fact that the project has solid deliverables and an ending point, the product itself will continue through the life cycle. Therefore, knowledge management is a critical system for pharmaceutical project management.
The system for knowledge management relies on an automatic update to a body of knowledge specific to each product. As such, the system must be put into place at the initiation of each project and must be updated throughout the project. The quality of this system depends upon consistent document practices and reliable updates. This includes all activities that contribute to the development of technical information, the transfer of critical project points, deviations, excursions, validation activities, procedural updates, and lessons learned. The document must be accessible when the product itself advances through the product life cycle.
As an example, if one facility was responsible for product development, there would be a single knowledge management document, which, upon project closure, would be part of the product package. If the product then advanced to clinical trial phase, this knowledge management document would be reviewed upon project selection to assist in risk analysis. A new knowledge management document would be initiated for the next phase, and so on. The system must be robust; all critical knowledge must be captured and retained in order to assure the next phase will also be successful, even if there is a large time gap between product phases.
Training the Personnel
For the PMG system to be successful, the PMGs must be supported and enforced by the organization from top to bottom. A significant part of this required organizational culture change involves PMG training of personnel from each project team member functional area, a human resource Knowledge Area requirement to develop the project team. Project team PMG training is an ongoing requirement, which must be formally documented. PMGs are regularly updated due to ongoing lessons learned and in order to keep current with PMBOK® Guide best practices.
Increased success of any endeavor is found when the technical aspects of a new process undergo training. Department-specific training is tracked by having as deliverables training documentation from functional area departments that participate on project teams.
Comments on Seamless Transfers Among Project Managers
One of the benefits of the PMG system is increased effective human resource utilization. Because projects are consistently managed via the PMGs, any project manager trained in those PMGs can readily take over a project at any stage. Furthermore, team members trained in the PMGs can temporarily manage team meetings. Because the system is consistently applied and understood, there is no impact to project quality when temporary or permanent changes are made to project managers or functional area team members. Another major benefit of a consistently applied and understood project management system is that management and stakeholders readily understand project status and project management issues.
Guidelines for Self-Evaluation of the Project Management Systems
Once PMGs are in place, the organization can evaluate performance based on successful execution of the PMGs. This involves creating metrics as well as routine evaluations of the project manager and project team member performance measured against PMG requirements. The projects themselves can be audited on a routine basis. Use of tools, timeline and scope performance, and project quality metrics can be applied. A good approach is for PMO management to routinely evaluate project managers. The project managers can evaluate team members, and team members can evaluate project managers. If the PMGs are aligned with the PMBOK® Guide, the organization is, in effect, measuring project manager performance against best practices. The PMGs should undergo revision on a routine and as-needed basis to keep up with the organization’s need or current trends.
Part of ongoing PMO evaluation is based on client feedback. Lessons learned from client feedback as well as daily operations are easily captured and integrated into PMG systems as revisions to the PMGs.
Project Management System Challenge Questions
- Do you have a documented project management system consisting of written PMGs based on PMBOK® Guide best practices?
- How is your PMO organized? How is management kept abreast of project status/issues?
- Are your project managers certified PMPs?
- Who is trained in the PMGs?
- Does your PMO maintain performance metrics?
- What happens once there is agreement on the project?
- What project management tools do you use to give assurance that the project will be successful?
- Do you capture lessons learned? How?
- Do you perform project risk assessments?
- Do you have a notification/problem-solving process when the product/process is jeopardized?
- Do your project teams have representation from each discipline?
- How do you manage scope? Schedule?
- What is your communication plan?
Self-Evaluation for Continuous Improvement
A pharmaceutical PMO interested in continuous improvement may request and receive performance feedback from clients. It is also important for PMOs to hold weekly staff meetings in which issues encountered each week are openly discussed and systems are subsequently improved based on these discussions. It is necessary to ask functional areas to provide feedback or insight into PMO areas needing improvement. In effect, one needs to establish and maintain a continuous improvement culture. This includes reviewing the PMBOK® Guide to ensure continuous refining and application of best practices.
Likewise a CMO may question clients regarding their expectations from the PMO project team. In this way, both facilities are educated and potentially learn about any gaps there are between the established systems and client expectations.
