Pharmacovigilance Inspections

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Objective of PV Inspections:

Pharmacovigilance specific inspections are conducted by the regulatory authorities to verify that pharma companies have adequate processes and comply with the existing regulatory requirements of PV. PV data & processes are also reviewed as a part of GMP and GCP inspections Objective of PV Inspections

Preparation- the key to success (1 of 3):

Review the findings of previous inspections, internal audits & third party audits Resolve all outstanding issues known for the system/facility to be inspected Review files and organization documents for completeness and validity, organize and update files and documents as appropriate Organize documents requested prior to inspection (if applicable) Preparation- the key to success (1 of 3)

Preparation- the key to success (2 of 3):

Inspection team Identify key sponsor contact (usually QPPv) for Europe Other members- scribe, leads for different functions (who will be interviewed), staff participating in introductory & closing meeting Preparation- the key to success (2 of 3)

Preparation- the key to success (3 of 3):

Don’t forget- Logistics- printing, photocopy, seating arrangement/ meeting rooms, lunch Best way to prepare Regular Self- inspection/ Internal Audits Preparation- the key to success (3 of 3)


This presentation is prepared from the book “Pharmacovigilance- An Industry Perspective” by Dr Deepa Arora This book includes a dedicated chapter on Pharmacovigilance Inspections Various subtopics covered in the chapter include: Source

PV inspections- subtopics (1 of 2):

Scope of pharmacovigilance inspections Practices that trigger PV Inspections Risk based inspections Data covered during the inspection Process of Inspection including Notification, introductory and closing meeting & highlighting the different approaches of various regulatory authorities PV inspections- subtopics (1 of 2)

PV inspections- subtopics (2 of 2):

Common inspection findings Grading of Inspection Findings How to prepare for pharmacovigilance inspections How to respond to the Inspection Report/ Form 483 Examples of potential inspection findings with potential corrective & preventive action PV inspections- subtopics (2 of 2)

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