Who is Responsible for Quality & GMP Compliance?

Every employee has a responsibility to the company to ensure that his or her responsibilities are met, thus assuring a quality product is produced. Who is responsible for GMP Compliance?

Everyone.

Quality and GMP Compliance are independent of job title and salary and have no boundaries. Building quality into processes, systems, documentation, and the employee’s mindset makes sustainable compliance more achievable. Employees take ownership of the processes and take pride in their work. Ultimately the employees benefit by working in a challenging environment and the operation has a greater chance of meeting and even exceeding industry standards and FDA’s expectations. The goal is to have employees be an integral part of the company and know that their ideas and opinions are valued. Retention of valued employees becomes easier and the company can focus on strategic plans for growth and forward quality. Regulatory compliance should not be the goal-quality should be. Building quality into the entire process of an operation requires commitment by executive management and the allocation of adequate resources (personnel, facilities, training, etc.).