Confidence Beyond Compliance

According to the Guidelines on Good Pharmacovigilance Practices (GVP) Module IV pharmacovigilance audit activities should verify, by examination and evaluation of objective evidence, the appropriateness and effectiveness of the implementation and operation of a pharmacovigilance system, including its quality system for pharmacovigilance activities. In general, an audit is a systematic, disciplined, independent and documented process for obtaining evidence and evaluating the evidence objectively to determine the extent to which the audit criteria are fulfilled, contributing to the improvement of risk management, control and governance processes.

PharmaLex applies its broad and long-term experience and global network to fulfill the requested support regarding the planning and conduct of pharmacovigilance audits. There are written procedures in place regarding the conduct of individual audits and comprehensive experience regarding the planning of audits (strategic level audit planning, tactical level audit planning and operational level audit planning). As a matter of course, PharmaLex auditors also conduct audits in accordance with the respective client procedures on audits.

PharmaLex is committed to provide a unique service partnership that offers global experience and an experienced audit team to ensure a successful collaboration between the clients and PharmaLex. PharmaLex ensures independence and objectivity of the auditors and meets the highest auditing standards. The proficiency of our audit team is gained through a combination of education, work experience and training. All auditors demonstrate and maintain proficiency in terms of knowledge, skills and abilities required to effectively conduct and/or participate in pharmacovigilance audit activities.

Therefore, the PharmaLex auditors are able to conduct pharmacovigilance audits at headquarter level, at local level (affiliates, distribution or license partners, service providers) and/or process audits (e.g. preparation and maintenance of Pharmacovigilance System Master Files (PSMFs) or preparation Periodic Safety Update Reports (PSURs)).

Moreover, PharmaLex can also support the follow-up activities of audits or Health Authorities inspections (i.e. the management of corrective and preventive actions (CAPAs)), if required. The goal of CAPA management is to convey timelines for actions that are appropriate, relevant, and in line with the relative risk to the pharmacovigilance system and to ensure that CAPAs are implemented and documented appropriately.