Key points
- Inspectors expect literature search strategies to be documented, reproducible, and capable of identifying relevant safety information.
- Database coverage must be justified and appropriate for the medicinal products being monitored.
- Search strategies must be version-controlled and updated when safety profiles or regulatory expectations change.
- Search execution must be evidenced through logs demonstrating when searches were performed and by whom.
- Governance processes must demonstrate that literature monitoring remains effective over time.
What inspectors expect
Each point below should be supported by controlled documents and traceable records.
- Literature search strategies are documented and reproducible.
- Database coverage is justified and appropriate for the product portfolio.
- Search execution logs demonstrate that literature monitoring occurs consistently.
- Search strategies are reviewed periodically and updated when required.
- Governance oversight confirms literature monitoring remains effective.
Summary
Pharmacovigilance literature search strategies determine how organisations identify potential safety information within the scientific literature. Inspectors assess whether these strategies are capable of identifying adverse reaction reports and whether they are controlled, reproducible, and governed appropriately. Evidence typically includes documented search strings, database coverage rationale, execution logs, and oversight demonstrating that literature monitoring remains effective throughout the product lifecycle.
Common questions
These are the questions this page is designed to answer directly.
- What do inspectors check in pharmacovigilance literature search strategies?
- How should literature search strategies be documented in pharmacovigilance?
- What databases should be used for PV literature monitoring?
- What evidence supports pharmacovigilance literature search strategies during inspections?
- What are inspection findings related to literature search strategies?
Evidence objects inspectors expect
Literature Search Strategy Document
- Documented search strings for each product or substance
- Defined scope of literature monitoring
- Version history for search strategies
Database Coverage Rationale
- Justification for database selection such as MEDLINE or Embase
- Documentation explaining how sources cover relevant safety information
- Evidence that literature sources are appropriate for the therapeutic area
Search Execution Log
- Logs showing when searches were executed
- Named responsible individual performing each search
- Evidence of exported search results or search outputs
Search Strategy Change Log
- Documented updates to search strings
- Rationale for changes to database coverage
- Evidence of review and approval for strategy updates
Search Governance Records
- Periodic review of search strategy effectiveness
- Governance meeting records reviewing literature monitoring
- Documentation showing that strategies remain aligned with product safety risks
Failure patterns
Search strategies exist but cannot be reproduced because the exact search strings or parameters were not documented.
Database coverage is insufficient or poorly justified, meaning relevant literature may not be captured.
Search logs are incomplete or inconsistent, preventing inspectors from verifying that searches were executed on schedule.
Search strategies are never reviewed or updated despite evolving product safety profiles.
Search documentation exists but does not match the way searches are actually executed.
What good looks like
- Search strategies are documented and reproducible.
- Database coverage is clearly justified and appropriate for the product portfolio.
- Search execution logs provide evidence that monitoring occurs consistently.
- Search strategies are periodically reviewed and updated when required.
- Governance oversight ensures literature monitoring remains effective.
Operationalisation
- Maintain controlled documentation for all literature search strategies.
- Record every literature search execution in a centralised search log.
- Review search strategies periodically to ensure they remain appropriate.
- Update search strategies when new safety information or regulatory expectations emerge.
- Retain evidence demonstrating that literature monitoring is functioning effectively.
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FAQ
What databases are typically used for pharmacovigilance literature searches?
Major biomedical databases such as MEDLINE and Embase are commonly used because they provide comprehensive coverage of scientific publications.
Do inspectors require documented search strings?
Yes. Inspectors typically expect search strings to be documented so that literature monitoring can be reproduced and audited.
How often should literature search strategies be reviewed?
Search strategies should be reviewed periodically to ensure they remain appropriate for the product portfolio and emerging safety information.
Can literature search strategies change over time?
Yes. Strategies should evolve as safety information changes, but updates should be documented and controlled.
What evidence demonstrates that literature searches were performed?
Execution logs, database outputs, and timestamps provide evidence that literature searches were performed according to schedule.
What is a common inspection finding related to literature search strategies?
A common finding is the inability to reproduce historical searches due to missing search strings or incomplete documentation.
Sources
Primary guidance used to inform this map. This page is a structured interpretation layer; always validate against the original source documents.
European Medicines Agency
- Good pharmacovigilance practices (GVP)View source
- GVP Module VI – Collection, management and submission of reports of suspected adverse reactionsView source
- Medical Literature MonitoringView source