LOGFILE No. 02/2012 - Pharmaceutical Quality System (PQS)


Main Elements of a pharmaceutical quality system (PQS)

Management responsibility

Author: Lothar Hartmann Ph. D.

Management commitment

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:

  • communicating the importance of meeting patient needs as well as regulatory (GMP) and legal requirements, including environmental, health and safety aspects,
  • ensuring that the organization has knowledge of the regulatory requirements,
  • establishing quality policy,
  • ensuring that quality objectives are established,
  • defining responsibilities,
  • fostering continual improvement,
  • defining methods to measure the organization’s performance,
  • conducting regular management reviews,
  • ensuring the availability of sufficient resources (manpower, time and infrastructure).

Quality policy

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.

Quality planning

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

  • S =Specific,
  • M = Measurable,
  • A =Achievable,
  • R =Relevant,
  • T = Time-framed

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:

  • to make sure that the processes needed for the PQS are established, implemented and maintained,
  • to report to senior management on the performance of the PQS and any need for improvement.

This representative should report to senior management.

Resource management

Senior management should determine and provide adequate and appropriate resources to implement and maintain the PQS, i.e.:

  • human resources
  • financial resources
  • materials
  • infrastructure (facilities and equipment)
  • time.

For more detailed discussion of resource management see GMP MANUAL chapter 1.D.2 Resource management.

Internal communication

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.

Management review

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:

  • audit observations/results (internal and external audits as well as inspections
    by authorities),
  • supplier qualification,
  • product conformity (product quality review),
  • complaint, deviation and manufacturing changes
  • feedback from outsourced operations
  • risk assessments and trending
  • process performance, e.g. key performance indicators (KPI),
  • status of corrective and preventive actions (CAPA),
  • follow-up actions from previous management reviews,
  • changes that could affect the PQS,
  • recommendations for improvement.

The output from the management review should include any decisions and actions taken relating to:

  • continual improvement of the effectiveness of the PQS and its processes,
  • continual improvement of product (relating to customer requirements),
  • setting priorities of activities and
  • resources needed.

Outsourced operations

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:

  • Assessment, prior to outsourcing, of the suitability and competency of the contract acceptor
  • Definition of responsibilities and communication processes for quality-related activities laid down in a written agreement
  • Monitoring and review of performance of the contract acceptor.