The audit in general is a systematic and independent examination of activities to determine whether the evaluated activities were performed according to defined requirements.
Pharmacovigilance (PV) system is defined as a system used by an organisation to fulfil its legal tasks and responsibilities in relation to drug safety. It is designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance. Pharmacovigilance tasks have to be carried out both for marketed and unmarketed products.
The PV audit activities verify, by evaluation of objective evidence, the appropriateness and effectiveness of the implementation and operation of a PV system including its quality system for PV activities. The audit evidence can be relevant and verifiable records, statements or any other information.
In accordance with the EU Guideline on good pharmacovigilance practices, Marketing Authorisation Holders (MAHs) are required to perform regular risk-based audits of their PV system, and can any time be inspected by a governmental or official drug regulatory authority, by license partners, internal auditors or others.
The aim of these audits is to conduct a systematic, independent, disciplined and documented process to obtain evidence of a functioning PV system; 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.
Dr. Haney Pharma provides PV Audits as well as advice and support to be well prepared for an external audit. Thus, all regulatory requirements are met. Dr. Haney Pharma as a Service Provider has an expert audit team with national and international audit experience and can adapt to a variety of situations to meet the expectations of its clients. While some clients prefer for contract auditors to use the SOPs of their organisation and associated tools, Dr. Haney Pharma can also provide its own document templates.