Last Updated on August 28, 2026
The management of DRAP is committed to maintaining and continually improving its Quality Management System (QMS), established and certified in accordance with ISO 9001:2015, applicable legislation and regulatory requirements for therapeutic goods. The QMS supports DRAP’s Mission and Vision by promoting effective, consistent, risk-based and internationally aligned regulatory processes that contribute to the protection and promotion of public health.
All DRAP offices, including Headquarters, Divisions, laboratories and field offices, are ISO 9001:2015 certified. The effective implementation, maintenance and continual improvement of the QMS is a shared responsibility across the organization.
To ensure the continued suitability, adequacy, effectiveness and alignment of the QMS with DRAP’s strategic direction, the Authority conducts periodic Management Reviews through the Management Review Committee (MRC). The MRC comprises the Chief Executive Officer and the 13 Directors of DRAP, providing an Authority-level forum for collective management review and decision-making on the performance and continual improvement of the QMS.
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
Management Reviews provide a structured mechanism for senior management to evaluate the performance and effectiveness of the QMS and consider, among other matters:
- Performance and effectiveness of the QMS and its processes;
- Progress towards established quality objectives;
- Results of internal and external audits;
- Feedback from stakeholders and other relevant interested parties;
- Performance of regulatory functions and key organizational processes;
- Status of actions arising from previous Management Reviews;
- Changes in internal and external issues that may affect the QMS;
- Risks and opportunities affecting regulatory and organizational performance;
- Adequacy of resources and organizational capacity;
- Training, competence and development needs of regulatory personnel; and
- Opportunities for improvement, innovation and enhancement of regulatory processes and services.
The Management Review process enables the MRC to assess whether established processes are delivering their intended results, identify areas requiring improvement, and make informed decisions regarding actions, resources, responsibilities and priorities necessary to maintain and enhance the effectiveness of the QMS. The QMS function facilitates the Management Review process by coordinating inputs from Divisions and offices, compiling relevant performance information, documenting decisions and recommendations, and monitoring the implementation of actions arising from Management Reviews.
An Internal Audit mechanism conducts periodic audits to assess conformity with ISO 9001:2015, established processes and applicable regulatory requirements. Audit findings, together with process performance, quality objectives, risks and opportunities, stakeholder feedback and other relevant information, form important inputs to the Management Review process. Management Reviews therefore provide a mechanism through which the CEO and Directors collectively evaluate QMS performance, identify strategic and operational improvement needs, and ensure appropriate actions are taken to strengthen regulatory processes and organizational effectiveness.
Through this systematic Management Review process, DRAP ensures that its QMS remains effective, responsive and aligned with its strategic direction, while fostering a culture of quality, accountability, risk-based decision-making, continual improvement and regulatory excellence across the organization.