Summary of GVP (Guideline on good pharmacovigilance practices ) modules- GVP I

 

(GVP) Module I – Pharmacovigilance systems and their quality systems

Anyone who starts working in PV or is working in PV has to know the GVP modules sooner than later. Although this documents are freely available on internet, we have to refer them on ongoing basis as per our questions rather than just reading it once. Also, despite reading them, they do appear overwhelming as its daunting to extrapolate what exactly is requirement. Hence my attempt to summarize it below.

This module describes the quality management systems that should be part of pharmacovigilance process. The details provided act like guiding principles of establishing pharmacovigilance processes in terms of SOP, Infrastructure, Technology, People and Organizational level expectations. It also provides insights into what are measures that are expected to showcase if the PV process is working efficiently.

Summarizing a high level points from the module for revision below.

In a nutshell, the expectations are below

Ø  Having a PV process that lay down in written agreements that PV process are robust, effective and legally complaint i.e. SOP, Work instructions, user manuals, trainings materials and records

Ø  Having system in place that can communicate and ultimately prevent or treat identified adverse reaction in patients and general population via different channels to HCP/Patients etc

Ø  Having process to disseminate most correct and current product related safety information to consumers and patients

Ø  Having process in place to collect AE, analyze and take actions via signal, risk etc. to ultimately prevent, correct or treat AEs

The module also provides insights on how MAH can ensure the process is effective by establishing measurable outcomes wherever possible to check if the QMS is working.

Usually below are some standard outcomes that are used as KPI (Key performance indicators): (Extrapolated from guidelines)

•      Serious and non serious cases submitted on time
•       PBRER, DSUR or any other aggregate report format submitted on time
•       Any signals detected and there submission on time
•      Any new risk or change in risk that was identified and how was it communicated to HCPs, Patients and consumers 
•      Any recent audit finding and how they were handled - measures taken and the timelines meet
•      Any non compliance in process- how they are tracked and corrective and preventive actions implemented

An audits are scheduled on set frequency internally and or risk based audits can also be conducted.

Other important details described in the module are below

1. Quality cycle and its steps 

2. Organizational level requirement for each process to have objective clearly defined in terms of roles, responsibilities, timelines, frequency etc

3. Involvement of leadership in each aspect of process to ensure PV process is efficient to meet legal obligations

4. Objectives of PV system to ultimately fulfill obligations for patient safety

5. Requirements for technology's and infrastructure and how to integrate quality.

6. Having compliance and record management system

7. Having system to track any non compliances i.e. audit, inspection, CAPA etc

For detailed read on the link below: 

https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-i-pharmacovigilance-systems-and-their-quality-systems_en.pdf

Written by:

Dr.shraddha Bhange.

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