A day of training on the practical tools and background for implementing PQR. The responsibility for managing the Pharmaceutical Quality System (PQS or also called QMS) lies with management.
They determine the vision and direction of the organization and provide the necessary resources to foster a culture of quality. Because the quality system must align with business needs, the Management Review provides an excellent opportunity for management to assess the QMS.
The task of ensuring that the QMS is annually reviewed for effectiveness lies with the QA department. The achieved objectives are evaluated and new objectives must be established. During these sessions, the progress of the multi-year plan is also discussed.
All of this within the framework of continuous improvement of processes, products and the quality system itself. The Product Quality Review (PQR) serves a similar purpose and assesses, among other things, the consistency and adequacy of current processes.
It also examines how adequate the current specifications for starting materials and finished products are. Together, these two assessments form the basis for identifying improvement points for process and product. To ensure the assessments run as efficiently as possible, good understanding and organization are required.
