It is a current expectation that GXP regulated companies have implemented an effective quality management system. Essential elements of such a quality management system are quality risk management and senior management involvement. Although these elements are well known in quality management systems based on ISO 9000 standards, for many pharmaceutical companies they are new and therefore companies are often unsure where to start.
Together with the increased pressure to reduce costs it allows pharmaceutical companies to reassess the design and operation of their quality management system. Van Loosbroek Farma Consult can assist companies in assessing the appropriateness of their current quality management system and where necessary provide recommendations and develop solutions to redesign the system while keeping it simple, functional and relevant to the business operations.
It is our philosophy that a lean and effective quality management system is only possible if all required system elements are in place and interlinked, and the system is lived up to by the entire organization.