Audits
Independent auditing is an essential component of a company’s Quality Management System1,2 and one that is required by regulatory inspectors. If carried out properly, it will provide an unbiased opinion of operational performance, measuring this against its own procedures, and ensuring that the system itself remains compliant with shifting regulations.
PrimeVigilance Consultants have many years of experience of conducting pharmacovigilance audits worldwide, and can develop a programme with a client company to ensure that all elements of their pharmacovigilance System are covered as appropriate.
PrimeVigilance can audit pharmacovigilance operations at headquarter, national affiliate and distributor level, with follow-up audits if required to ensure corrective measures are completed appropriately.
Statutory pharmacovigilance inspections by regulatory authorities – especially in the EU – have become increasingly intensive and wide in scope in recent years. Effective pharmacovigilance audits help to identify and resolve compliance issues in a cost-effective planned manner, before the regulatory inspectors impose punitive demands on companies to carry out urgent remedy.
1Brown EG, Goldman SA. Preparing for regulatory inspection of company pharmacovigilance systems and practices in the European Union and United States. In Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA Professional. Royal Society of Chemistry, 2007
2Brown EG Preparing for a European pharmacovigilance regulatory inspection. Pharmacoepidemiol Drug Safety 2002 11 S238
Audits: Compliant and Prepared
- just one of the pharmacovigilance services from PrimeVigilance
For more information contact PrimeVigilance today