Management Reviews

Last Updated on February 21, 2022

The management of DRAP has implemented and committed to continually improve its quality management system which is established in accordance to the standards of ISO 9001:2015 and legislative requirements of national regulatory system for therapeutic goods. Quality Management System of DRAP is aimed at enhancing access to quality assured, safe and efficacious therapeutic goods through a robust and well functioning national regulatory system for Universal Health Coverage and attaining Sustainable Development Goal 3. A Well-functioning regulatory systems able to apply globally accepted standards ensuring that the level of control is proportionate to the level of public health risk.

Developing, Implementing and continually improving Quality Management Systems for performing all regulatory functions within the mandate of DRAP, to ensure safety, quality and efficacy of therapeutic goods for the people of Pakistan

All Divisions and laboratories of DRAP are responsible for effective implementation of Quality Management System in their process and services being performed. The Authority has established a Management Review Committee which periodically monitor and review the performance of Quality Management System.

Pursuing its way to achieve the goals as set out in DRAP’s mission statement, Quality Management System is intended to ensure that quality is central to all aspects in the work by:-

  • Ensuring that a documented and effective Quality Management System conforms to the requirements of ISO 9001;2015,
  • Performance of the Quality Management System,
  • Analysis of risks and opportunities for improvements
  • Ensuring the standard process designed by the Divisions are delivering the intended results
  • Enhancing capacity building through training of staff to maintain an experienced team of regulatory personnel, committed to achieving quality objectives

The quality management system is being implemented by the collaborative effort of all DRAP’s staff, facilitated by a dedicated QMS Cell for enhancing communications within the organization and coordinate work. In addition, an Internal audits team has also been mandated to convene periodic internal audits for monitoring conformance to the standards and compliance to the legislative regulatory requirement. This helps management in monitoring of quality assurance to ensure that our system is operating at satisfactory level of effectiveness, and ultimately contributes to the improvement of systems and processes.