A Systems-Based Team Approach to GMP Compliance - - BioPharm International


A Systems-Based Team Approach to GMP Compliance

BioPharm International
Volume 19, Issue 9


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.
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.

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 products.


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.

Figure 2. Core Team Structure Recommended organizational structure for a core team approach to creating an effective quality system for a pharmaceutical company:
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.

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.

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