734 _ Industrial Pharmacy: A Comprehensive Approach Design and Content Consideration ‘The design, organization and documentation of the pharmaceutical quality system should be well structured and clear. So that it becomes useful for common understanding and consistent application. The well designed pharmaceutical quality system should assure the quality of outsourced activities and purchased materials too. For this it should include appropriate processes, resources and responsibilities. It should clearly mention the management responsibility also. Quality Manual It is a document that describes the pharmaceutical quality system of the company. It includes the description of the following: © Quality Policy of the company, * Scope of the pharmaceutical quality system, © The pharmaceutical quality system processes, their sequences, linkages and interdependencies should be identified. Process maps and flow charts can be used as tools to help illustrating pharmaceutical quality system processes in a visual manner; © Management responsibilities within the pharmaceutical quality system. Quality Policy Each manufacturing company should have a policy on quality of their products. tis the managements’ responsibility to define, display, and ensure. * Senior management should set up a quality policy that describes the overall objectives and direction of the company towards quality. * The quality policy should mention the expectation and compliance of the regulatory requirements, and should ease continual improvement of the pharmaceutical quality system. ‘* The quality policy should be known and understood by employees of all levels in the company. © The quality policy should be reviewed periodically for continuing effectiveness. Management Responsibility Leadership is necessary to set up and maintain a company-wide commitment to quality and for the performance of the pharmaceutical quality system. Responsibilities of the management are to: © participate in the designing, implementation, monitoring and maintenance of an effective pharmaceutical quality system, © demonstrate strong and visible support for the pharmaceutical quality system and ensure its implementation throughout their organization, Ul O <