GVP – Module III: Pharmacovigilance inspections

REVISION 1 in force from: 16. 9. 2014

MODULE - FULL TEXT

Module III: Pharmacovigilance inspections (full text)

MODULE - DETAILS

III.A. Introduction

III.A. Introduction

III.B. Structures and processes

III.B.1. Inspection types

III.B.2. Inspection planning

III.B.3. Sites to be inspected

III.B.4. Inspection scope

III.B.5. Inspection process

III.B.6. Inspection follow-up

III.B.7. Regulatory actions and sanctions

III.B.8. Record management and archiving

III.B.9. Qualification and training of inspectors

III.B.10. Quality management of pharmacovigilance inspection process

III.C Operation of EU network

III.C.2. Role of the European Medicines Agency

III.C.3. Role of the European Commission

III.C.4. Role of the Member States

III.C.5. Role of marketing authorisation holders and applicants

III.C.6. Inspection fees

III.C.7. Transparency