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


A Systems-Based Team Approach to GMP Compliance

BioPharm International
Volume 19, Issue 9


Documenting a quality system on paper is not enough to assure a company's regulatory or business health. If organizational values are not in sync with quality principles, procedures may get changed but behaviors may not. In this situation, any system corrections that are made will not last. The values reflected in the company's organization and support systems impact behaviors that ultimately influence the manner in which the quality system is executed. The manner in which employees are motivated, rewarded, compensated, and promoted influences their behaviors. Sometimes little attention is given to the behavioral impact these support systems have on a company's quality system implementation. The actions of management, particularly when in conflict with its words, communicate clear messages to the organization. Implementing a systems-based team approach to enhancing the quality system itself can have a positive effect on culture, but a concerted effort must be made by management to assure alignment of values with the quality system. This can be very difficult.

Using organizational development and management tools, the company must determine which assumptions and beliefs support or hinder successful implementation of a new quality system. Communication must be planned and managed to assure clarity, effective conveyance of key ideas, and consistent support of ongoing development. Support systems—particularly those involving human resources policies, compensation schemes, career planning, recognition and reward systems, hiring and promotion practices, among others—must be evaluated to assure alignment. Providing the necessary attention to organizational culture can speed the process of quality system implementation, as well as assure its ultimate success.


Establishing a quality system that meets a company's regulatory and business needs is challenging. Companies faced with real or threatened FDA sanctions are usually least prepared to react effectively. Frequently, their efforts of the past have been unsuccessful, leaving little insight into new approaches. However, even a company in this situation can develop a successful approach if it recognizes the value of a systems approach to creating a quality system, understands the value of a robust quality system in achieving regulatory and business objectives, and appreciates the impact and role of organizational culture. With this foundation, a process employing interdisciplinary, systems-focused teams can result in a sustainable, compliant quality system that can withstand regulatory challenge and achieve efficiencies that meet the business needs of the company.

Ron Johnson is the executive vice president of The Lewin Group, a Quintiles company. Maxine Fritz is the vice president of pharmaceutical quality systems and validation services for Quintiles Consulting.

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