Abstract
In a global quality assurance environment, a system audit of pharmacovigilance is undertaken to check whether regulatory requirements and company quality policy are fulfilled. The most serious abnormalities in this field are: overlooking serious adverse events; a deliberate or involuntary bias toward attenuation of seriousness or causality; and inconsistency between source documents, case documentation files, and reports to authorities. Limits of the audit mission should be first defined (only the pharmacovigilance department or will it be extended to the regulatory, biometric, and labeling departments?).
In-depth preparation, possibly aided by a specialist in pharmacovigilance, is necessary to know the requirements and the type of data. The following points will be examined:
Competence and experience of personnel in charge of documentation and causality assessment Adequacy, comprehensiveness, and realism of procedures, and A sample of cases of adverse events (available documentation).
Different functions should be considered:
How is documentation on cases gathered, completed, and checked? How is causality assessment done? How is the information on serious adverse drug reactions (ADR) distributed inside and outside the company? How is reporting to authorities (in different countries) done? How is coding of ADRs done and checked? What computer system is used, what can it do, and how well? How are decisions to improve drug safety made? Is there any preparation in case of a major crisis due to a traumatic safety problem ?
This type of audit, which is still not very common in practice, should become systematic in the future because the procurement of complete and credible information is of vital importance in the area of drug safety.
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