1. Pharmacovigilance inspections: what HPRA expects
Michael McDonald, PhD
HPRA Veterinary Medicines Information Day
13 June 2018, Hilton Hotel Dublin Airport, Dublin.

2. Purpose of inspections
Monitor compliance of MAHs with their PhV obligations
Verify MAHs have a PhV system in place to assume responsibility for VMPs on the market so that appropriate action may be taken by the MAH when necessary
Verify MAHs have a QPPV at their disposal, who is responsible for the establishment and maintenance of the PhV system
Verify MAHs have a deputy QPPV available to them and that back-up procedures apply in case of absence of QPPV
Ensure corrective and preventative action is taken for any non compliances identified
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3. The HPRA inspection programme
Conducting inspections of veterinary MAHs since 2009
Eleven veterinary PhV inspections conducted to date
National inspection programme reviewed and developed annually
Coordination with European network for centrally authorised products
Inspections may be routine or targeted
Routine inspections
Targeted inspections
Part of ongoing monitoring programme
Specific issues are identified that indicate that a PhV system may be non-compliant or there is potential for increased risk of non-compliance
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4. MAHs may be prioritised based on factors such as:
Routine inspections
MAHs may be prioritised based on factors such as:
Number of MAs held
Type(s) of products authorised
Subcontracted PhV responsibilities
Significant organisational changes
PhV compliance profile
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5. Conduct of inspections
Typically, two to three days in duration
Inspection team consists of inspector(s) and one assessor
Key components examined:
Organisation inc. defined roles and responsibililities for PhV
The QPPV and deputy
The Detailed Description of the Pharmacovigilance System
The quality management system
Adverse event case processing and reporting
Periodic Safety Update Report preparation and submission
Signal management inc. safety variations
Contracts and agreements with third parties
Examined through combination of document review and interviews
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6. Conduct of inspections
Deficiencies categorised according to EU agreed definitions, as:
Critical
Major
Minor
Findings discussed with MAH throughout inspection, in so far as possible
Confidential inspection report prepared and issued to MAH
MAH response may request correction of any factual errors and should include proposed corrective and preventative actions
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7. Vet PhV inspection findings 2009-2018
Examples
Incomplete or late training
Written procedures for key PhV activities missing or not well defined
Late submission of PSURs or SAEs
Failure to submit follow-up information on AEs or incorrect classification of AEs
Top three areas
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8. Other common findings and how they can be avoided
Contractual agreements unclear with respect to PhV roles and responsibililties
24 hour access to QPPV
PhV audits – internal and external
Failure to define processes to ensure collection of AEs from all potential sources
Access to a veterinarian, if required
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9. Key areas examined during inspection
QPPV
Backup arrangements are clearly detailed
Adequate documentation is maintained regarding QPPV responsibilities and oversight
DDPS
DDPS regularly reviewed and maintained
Variations submitted to competent authorities as necessary
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10. Key areas examined during inspection
PSURs and AEs
SOPs are in place, adequately cover all activities, and are reviewed and updated as necessary
Accurate and complete records from time of case creation to close-out!
Timely reporting to HPRA
Contracts and agreements
Signed and dated contracts/agreements in place with all relevant third parties
Roles and responsibilities regarding PhV clearly defined
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11. Key areas examined during inspection
Signal detection and literature searches
Written procedures in place, with responsibilities and timelines clearly defined
Appropriate methodology, use of data sources and periodicity
Safety variations managed in a timely manner
Product quality complaints
Interface between Quality Assurance and PhV
Product quality complaint and AE logs review and reconciliation
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12. Key areas examined during inspection
Written procedures
Written procedures, defining processes for all relevant PhV activities
Periodic review, with subsequent updates where necessary
Training
Ensure all relevant personnel have received at least basic PhV training and that the collection of AEs is assured
Training records complete and up-to-date
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13. Queries?
For queries relating to the HPRA’s veterinary PhV inspection programme contact
For queries regarding specific PhV obligations for veterinary MAHs and the underpinning standards contact
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14. Thank you