Pharmacovigilance Quality management system – Introduction

Health agencies, in particular the US Food and Drug Administration (FDA) and European Medicine Agency (EMA) have detailed requirements on how to set up a quality system in pharmacovigilance to ensure the Quality. 

What a Quality System is, its purpose, and what it typically includes?

The pharmacovigilance quality management system (QMS) can be defined as the framework of the policies, procedures and systems that are necessary to ensure that the activities relating to the detection, assessment, understanding and evaluation of adverse effects or any other medicine-related problem relating to medicinal products are handled in compliance with applicable laws, regulations and company expectations.

The purpose of a QMS is to ensure that all pharmacovigilance activities are performed to the highest ethical standards and conform to relevant regulatory requirements and contractual obligations to any licensing partners. Key elements include a quality policy, an approved documented library of SOPs, quality control procedures, key performance indicators (KPIs), job descriptions, and training plans. It also cover organisational structure, responsibilities, procedures, processes and resources of the pharmacovigilance system as well as appropriate resource management, compliance management and record management.

A QMS is part of continuous process improvement. Within the QMS each process is reviewed through quality control steps within the process. The result of the quality control is measured against defined KPIs. Deviations from defined processes are identified, and those suggesting a quality issue are addressed through a root cause analysis followed by the creation of a corrective action and preventive action (CAPA) plan. Quality assurance can then check to ensure that quality is being managed within the pharmacovigilance department and that all quality issues are being addressed.

The quality system shall be based on all of the following activities:

• Quality planning: establishing structures and planning integrated and consistent processes; (ex: Clear written standard operating procedures) 
• Quality adherence: carrying out tasks and responsibilities in accordance with quality requirements ;
• Quality control and assurance: monitoring and evaluating how effectively the structures and processes have been established and how effectively the processes are being carried out; (ex: correct data entry and coding, audit system). 
• Quality improvements: correcting and improving the structures and processes where necessary