BREAKING THE CYCLE WITH A SYSTEMS APPROACH
A systems-based approach is the key to breaking the cycle of GMP failure. FDA has identified six subsystems (See Figure 1)
reflected in the pharmaceutical GMP. Together these subsystems make up a quality system. A systems approach leads to effective
and sustainable corrections to FDA inspectional findings or a Warning Letter. The most significant benefit, however, is that
it proactively prevents GMP problems.
Figure 1. The diagram below shows the relationship among the six subsystems in pharmaceutical manufacturing—the quality system
and the five manufacturing systems. The quality system provides the foundation for manufacturing systems that are linked to
and function with it to achieve compliance and consistently produce a quality product.
FDA first recognized the value of a quality system approach to GMPs in its 1996 publication of the Quality System Regulation
for Medical Devices. FDA realized that a quality system provides the means for assuring consistently high quality of healthcare
USING "CORE TEAMS" TO IMPLEMENT THE SYSTEM APPROACH
A systems-based approach to establishing a competent quality system can be effectively developed and executed using an interdisciplinary
team structure formed around the subsystems of the GMP regulations (for drugs or devices, Figure 2). Each core team, representing
a subsystem, is chartered to initially define the existing assigned subsystem and to assess its performance using various
quality data. Based on their findings and employing risk-assessment principles, each team designs a new subsystem assuring
the controls incorporated are commensurate with the risks posed. This may involve building on what exists, completely redesigning
it, or more commonly, doing both. This process frequently identifies opportunities to improve process efficiency in a context
that assures a proper balance between efficiency and compliance.
Next, the team creates documentation to support the level of controls that have been created. The team identifies metrics
to be used in assessing future performance, training needs and necessary linkages between the subsystems. The team also eventually
oversees the implementation of the new subsystem.
Critical to the success of this process is the interdisciplinary make-up of the teams—all stakeholders should be represented,
i.e., quality, manufacturing, research and development, engineering, marketing, etc. This enriches the talent pool that will
contribute to the creation of the subsystem and prevents the development of subsystems that are not workable throughout the
organization. Each team should have an external third-party expert member to provide an objective perspective, provide technical
and regulatory advice and aid the team in avoiding cultural "blind spots." A process facilitator can assure team efficiency,
achievement of milestones, and resolution of issues.
Figure 2. Core Team Structure Recommended organizational structure for a core team approach to creating an effective quality
system for a pharmaceutical company:
Overseeing the entire project is the steering committee that may be variously called the leadership or management team. It
consists of senior-most managers representing the various functional areas of the company along with a third-party senior
management expert for objective regulatory assistance. This team establishes the vision, provides the necessary resources
and commitment, assures linkages between the various teams, serves as the change agent for cultural and system issues, and
resolves issues that invariably surface during the course of the project. It also reflects senior management's commitment
to quality. A project manager is often required to assure the project is completed on budget and on time.