The entry into force of the new legislation on pharmacovigilance in July 2012, established legal requirements for marketing authorisation holders to perform audits of their pharmacovigilance systems, including risk based audits of their quality systems.
Pharmacovigilance audit activities ashould verify the appropriateness and effectiveness of the implementation and operation of a pharmacovigilance system, including its quality system for pharmacovigilance activities.
Pharmacovigilance audit activities ashould verify the appropriateness and effectiveness of the implementation and operation of a pharmacovigilance system, including its quality system for pharmacovigilance activities.
The marketing authorisation holder shall place a note concerning critical and major audit findings of any audit relating to the pharmacovigilance system in the pharmacovigilance system master file (PSMF). Based on the audit findings, the marketing authorisation holder shall ensure that an appropriate plan detailing corrective and preventative action is prepared and implemented. Once the corrective and preventive actions have been fully implemented, the note may be removed.
Revipharm offers an external independent auditor to carry out routine audits. We can assist with preparation and implementation of the post-audit or post-inspection Corrective and Preventive Action Plan (CAPA).
For more information, please contact us or visit our website
Other related links:
Update date: 10-01-2016
Other related links:
- Literature review
- Pharmacovigilance system master file
- Qualified person responsible for pharmacovigilance in the EU
- Pharmacovigilance responsibilities of the MAH at EU
- Safety Data Exchange Agreements (SDEAs)
- Persona de contacto de Farmacovigilancia en España
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