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PV Quality Management

A pharmacovigilance system is defined as a system used by an organisation to fulfil its legal tasks and responsibilities in relation to pharmacovigilance and designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance. A pharmacovigilance system, like any system, is characterised by its structures, processes and outcomes.

The quality system is part of the pharmacovigilance system and consists of its own structures and processes.

MAHs must have a Quality Management System (QMS) in place to support PV activities that have been implemented to meet PV guidelines.

The quality system covers:

  • Organisational structure
  • Responsibilities
  • Procedures and processes
  • Resources and resource management
  • Compliance management
  • Record management

The quality system comprises interlinked steps for planning, adherence, control & assurance, and improvement, which forms the quality cycle in GVP.

Quality Measurement

Quality should be measured and reviewed on a defined periodic basis. Checking and measuring quality is about the way in which the process has been conducted rather than the results.

It is measured in increasing frequency from regulatory authority inspection which provides an official review of the PV system, through to QA/ audits which give independent assurance of compliance at a single point in time, to the continual process of monitoring QC, which is a pivotal part of the QMS ensuring the required standards are being met.

Regulink’s PV service provides flexible support to its clients with all of the essential features of the pharmacovigilance quality management system:

  • PQMS build support (procedures, resources, training, record management, documentation)
  • Creation and maintenance of written procedures for PV (e.g. SOPs) with periodic review (e.g. annual) to ensure they reflect current practice
  • Creation of tactical level and strategic level audit plans
  • Representation/ participation in PV inspections and QA audits
  • Conduct mock inspections

OTHER PHARMACOVIGILANCE SERVICES

Whether it be the longer term engagement of a contract QPPV or specific pharmacovigilance activities, Regulink is here to support you in meeting your post-authorisation and clinical trial needs. From case processing to periodic reporting, and risk management to SOP development, find out more about our services here.

Pharmacovigilance System Master File (PSMF)

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Safety Reports

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Eudravigilance

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Risk Management Activities

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Case Management / Safety database/ Literature

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Risk Management Plan

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