Regulatory authorities conduct pharmacovigilance inspections of pharmaceutical companies to ensure adequate PV processes and compliance. Inspections review PV data and processes as part of GMP and GCP audits. Companies should prepare by resolving previous issues, reviewing files for completeness, and identifying contacts. It is best to regularly conduct internal self-inspections and audits. This information is from the book "Pharmacovigilance - An Industry Perspective" which provides an in-depth chapter on pharmacovigilance inspections.

2.  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

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)

4. 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

5. Don’t forget-
 Logistics- printing, photocopy, seating
arrangement/ meeting rooms, lunch
Best way to prepare
 Regular Self- inspection/ Internal Audits

6.  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:

7.  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

8.  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

9.  e-mail
info@pharmapublisher.com; pharmapublisher@y7mail.com
 By phone- call us at: +91-8108699389
 Cost of the book (includes delivery charges)
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