Running Head: PHARMACOVIGILANCE AUDITS0Pharmacovigilance AuditsStudent details[Pick the date]
PHARMACOVIGILANCE AUDITS 1Table of ContentsIntroduction................................................................................................................................2Steps involved in pharmacovigilance audit................................................................................3Planning and preparation........................................................................................................3Audit conduct.........................................................................................................................4Reporting and follow up.........................................................................................................5CAPA.....................................................................................................................................5Conclusion..................................................................................................................................6References..................................................................................................................................8
PHARMACOVIGILANCE AUDITS 2Pharmacovigilance AuditsIntroduction Pharmacovigilance audits are the essential component of every pharmaceutical organization’squality management system. If it is conducted correctly, it can provide an impartial opinion of operational presentation of pharmacovigilance system, comparing the system against its own methods and regulatory guidelines. It makes sure that the system remains compliant withregulations 1.Pharmaco-epidemiology is defined as the study of the drugs used in a large population1. The pharmaco-epidemiological studies use pharmacokinetics and pharmacodynamics of a diseased person to predict the effects of the drugs on patient 2.The objective of a pharmaceutical audit is to evaluate the arrangement in a place to meet the regulatory needs applicable to systems of pharmacovigilance (PV). The audit also verifies that whether the arrangements are properly and consistently implemented, and appropriateness of the documentation. Importance of a pharmacovigilance audit To make sure compliance with organization procedure and global or local regulatory requirementsTo Make sure company regulatory criteria’s are met To evolve regulatory needs To increase regulatory inspection of risk To identify quality improvementsThe most effective PV audits contribute to find-out and rectified the compliance issues or adverse events in a cost-effective and well-planned manner 3.
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