Leadership, commitment and the active involvement of senior management are essential to the effective functioning of the PQS.
Senior management should provide evidence of its commitment to the development and implementation of the Pharmaceutical Quality System (PQS) by:
Senior management should stress the importance of compliance with regulatory/GMP requirements and the continual improvement in performance of the PQS. This should be explained in the quality policy.
The quality policy demonstrates senior management’s commitment to quality and to the provision of adequate resources.
Measures have to be initiated to ensure that the key statements of the quality policy become part of daily business. Therefore, the quality policy needs to be communicated and understood at all levels within the organization. Quality is the responsibility of all persons involved in a process.
To cope with the changes that inevitably occur in and around the organization, the quality policy should be reviewed for continuing suitability. The responsibility for these activities is clearly allocated to senior management.
Senior management is responsible for the quality planning of the organization.
Quality Planning may be driven e.g. by strategies and organizational objectives, by patient needs, by regulatory requirements, or by risk management. This may give rise to, e.g. skill and knowledge requirements, allocation of task responsibilities, resources (financial and infrastructure), performance indicators and contingency plans.
Senior management should establish Quality objectives that are known and widely used at all levels within the organization. They should be measurable and consistent with the quality policy.
The “SMART” criteria
should be applied to establish quality objectives.
The outputs of quality planning should be submitted for Management review (see GMP MANUAL chapter 1.D.1.7 Management review).
Senior management should make sure that responsibilities and competencies are defined for all profiles and that they are communicated to all levels within the organization.
People throughout the organization should be given the responsibilities and authority necessary to enable them to contribute to the achievement of quality objectives.
Senior management should appoint a representative who, irrespective of other responsibilities, is responsible and authorized:
This representative should report to senior management.
Senior management should determine and provide adequate and appropriate resources to implement and maintain the PQS, i.e.:
For more detailed discussion of resource management see GMP MANUAL chapter 1.D.2 Resource management.
Senior management should ensure that appropriate communication processes are established between all levels of the organization. This should include the communication of GMP and regulatory requirements as appropriate to each level in the organization. Quality issues should be considered as a standard topic on the agenda of all appropriate meetings. Procedures should exist for notifying responsible management of quality-critical situations in a timely manner.
Senior management should review the organization’s PQS at predefined intervals to ensure its continuing suitability, adequacy and effectiveness. This review has to include the assessment of opportunities for improvement and the need for changes to the PQS, including the quality policy and the quality objectives.
The review should also cover environmental, health and safety aspects. Records of management reviews are to be maintained.
A consolidation of available data is to be provided as input to senior management review to support their decision-making process.
These data include, but are not limited to:
The output from the management review should include any decisions and actions taken relating to:
The management responsibilities described in this section extend to the control and review of any outsourced activities. It has to be ensured that measures are in place to assure the quality of product and processes: