(GVP) Module III – Pharmacovigilance inspections
Continuing the series on Guideline on good pharmacovigilance practices, in this blog i will jump right into module III having covered module I and II in previous blog.
This module describes the pharmacovigilance inspections, why are they conducted, what is the goal, who conducts and when are they conducted.
Overall, the module does go in more and clear details on expectations and its best to read module thoroughly and completely when one has to lead, participate or contribute to an inspection themselves.
1. What is inspection ?
An inspection is done by national competent authority (NCA) or EMA agency of MAHs systems, processes and personnel to ensure they are fulfilling all legal obligations required to ensure risk benefit monitoring of product authorized in EU for safeguarding patient safety.
2. When are inspections conducted?
1. Routine inspections : This are conducted routinely as per agency's risk monitoring based approach.
2. For cause inspections : This inspections are conducted when agency or NCA is inspecting any non compliance or failure of MAH to fulfill any PV obligations.
"As a general approach, a marketing authorization holder should be inspected on the basis of risk-based considerations, but at least once every 4 years"
Interesting examples given in module are below:
2. 1. Risk benefit balance
When MAH fails to inform about withdrawal or suspension of product
Any change in risk benefit was not communicated properly
2.2. PV obligations
Not submitting ICSR, PSUR or any other documents with quality and on time
2.3. Failure to respond to NCA/Agency requests
Not responding with adequate data and/or correct data at correct time
3. Who conducts inspections?
Inspector appointed and approved by agency and/or NCA.
4. Types of inspections:
4. 1. Routine inspections : Conducted routinely as part of risk based approach at agencies end.
4. 2. For cause inspections as noted above some of the causes.
4. 3. Pre authorization inspections : This inspections are conducted for MAH who are applying for first time authorization in EU and Agency/NCA wants to ensure MAH has robust, efficient PV process
4. 4 Post authorization inspections: This inspections are conducted as follow up to preauthorisation once the approval is granted to ensure the MAH is legally compliant and also has all the required process and systems in place
4.5 Announced and unannounced inspection- as the name suggests some inspection are preplanned and informed with agenda and details to MAH i.e. announced and some are unannounced when the agency/NCA has reasons to conduct the same
Other types are follow up, remote, system specific, product specific inspections.
5. Common process or systems that are inspected
1. ICSR- Death and SUSAR cases are picked up
2. Products- those that have been recently approved or have been identified with new signals/risks or safety concerns
3. Aggregate reports - PSUR for products that was delayed, inadequate or has inconsistent data
4. Signal or risk management : Signal process overall especially documentation of any downgraded or closed/invalid signals and for risks that have been recently identified and for which there are minimization measures in place
5. Products or clinical studies that are closed and have been used as basis for approval . Any study for which GCP inspection flagged an issue.
Ideally, the more detailed module should be referenced to know more about inspection planning, reasons, outcomes and expectations.
6. Outcome of inspections:
A MAH will be required to provide and responds with documented evidence to agency/NCA for every inspection observation, minor or major findings with stipulated timelines for every corrective or preventive actions. An agency or NCA may take action on MAH based on this which maybe - warning, withdrawal, suspension, conditional approval etc.
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