EU Guidelines on Good Pharmacovigilance Practices (GVP Module IV), mandate that all Marketing Authorisation Holders (MAHs) perform audits of their Pharmacovigilance Systems.
The goals of these audits are to conduct a systematic, disciplined, independent, and documented process to obtain evidence of system function; to evaluate the evidence objectively and determine whether the system meets its goals; and then to contribute to improving risk management, control, and governance processes.
PVpharm provides a risk-based Pharmacovigilance Audit Service, which focuses on the areas of highest risk to an organisation’s pharmacovigilance system, taking into account applicable local regulatory requirements.
How does it work:
First, an audit plan is agreed between PVpharm and the client, including the areas to be audited. The length of the audit will depend on these areas. A standard pharmacovigilance audit can be conducted within 2 to 4 working days.
Then, the audit is officially announced and the audit agenda is created to facilitate the conduction of the audit. The relevant client documentation and processes will be exchanged and reviewed prior to the onsite audit with total safety and confidentiality.
During the conduction of the audit onsite, the rest of the documentation will be reviewed, and the main findings will be highlighted.
Finally, a preliminary audit report covering all the documentation and findings of the audit will be send to the client for review, and after the clients comments are processed, a final audit report will be generated, including the development and implementation of Corrective And Preventative Action Plans (CAPA).
If you are a sponsor of clinical trials, we can support you with GCP audits. These services help to ensure that adoption of the principles of GCP meet international standards where trials are conducted to test both medical and non-medicinal products such as nutritional foods or cosmetics. We can Document review and audit your SOPs, Clinical GCP Protocols and Reports. We can also audit your submissions for ethical approval, Trial facilities, Critical Phases of the trial, Quality Systems and we can also perform sub-contractor audits.
PVpharm can help to create a robust Quality System in Pharmacovigilance. We can adapt your SOPs to the latest GVP guidance or create the Pharmacovigilance Quality System to be compliant.
PVpharm can help you in the design and adaptation of your facilities. We can help you with the implementation and management of the quality assurance system, including the completion or review of all quality documentation. We can prepare you for the Competent Authority inspections, verification of suppliers and business partners and also with staff training.
PVpharm can help to create a robust Quality System in Pharmacovigilance, Clinical Trials and GMP. We can adapt your SOPs to the latest GxP guidance or create a brand new Quality System to be compliant with GxP regulations.