Pharmacovigilance audits are an essential component of any pharmaceutical company’s Quality Management System. If carried out correctly, auditing provides an unbiased opinion of operational performance of the Pharmacovigilance system, measuring the system against its own procedures and against the regulatory guidelines, and ensuring that the system itself remains compliant with the regulations.
Why are good Pharmacovigilance Audit practices so vital?
Statutory Pharmacovigilance inspections by regulatory authorities – especially in the EEA – have become increasingly intensive and wide in scope in recent years. GVP Modules III (Pharmacovigilance Inspections) and Module IV (Pharmacovigilance Audits) provide detailed requirements for the establishment of a good auditing programme by a Marketing Authorisation Holder.
Moreover, effective pharmacovigilance audits help to identify and resolve compliance issues in a cost-effective, planned manner, before the regulatory inspectors impose punitive and costly demands on companies to carry out urgent remedial actions.
Risk Based Pharmacovigilance Audits
Risk Based Pharmacovigilance Audits are conducted according to the need to identify problems at different stages of the drug safety processes. Expert advice is required to adequately develop and implement three distinct elements of good practice in order to gain the benefits of a comprehensively planned approach versus the cost of remedial actions.
1. Strategic long term planning
A 2 to 5 year high level scheme which lists audits, topics to be examined, the methods to be employed and the theoretical approaches underpinning this work. Your strategy should address all aspects of drug safety work, including:
all routine and extraordinary processes and tasks involved
the quality system which provides the framework for these activities
liaison with interested parties both within the company and externally
liaison with regulatory authorities
2. Developing A Robust Programme
The development of an approximately 12 month plan which forms the latest phase of the audit programme. This needs to deliver on the principles, structure and practices to be followed as stipulated throughout the Strategic Plan. The Programme needs to address areas which have required further input in the past, and those areas where a higher risk potential has been identified. It should then be the driver for all pharmacovigilance processes and tasks, the controls which operate around those and the relevant quality system. In accordance with legislation, these tactical audits must take place at regular intervals and reliable professional advice will therefore be required to ensure all practices are compliant.
3. Individual Audits
Each one needs an unequivocal and individualized plan from the very start. Every step, every aspect must be adequately documented, with clear evidence of the timeframes involved and the manner in which the work is to be undertaken, including standard methodologies and communications practices.
Reporting and Remedial Action
The results of audits must be communicated to upper management and regulators according to the highly specific framework laid down by EU drug safety law1. The formulation of responses from the company to regulators in relation to inspections requires a high level of expertise. Devising and implementing the appropriate Corrective and Preventive Action Plan (CAPA) is also an issue where professional support should be sought.
PrimeVigilance consultants and executives have many years of experience of conducting pharmacovigilance audits worldwide, and develop programmes with client companies to ensure that all elements of their pharmacovigilance system are covered as appropriate.
The team can audit pharmacovigilance operations at headquarter, national affiliate, distributor and partner level, with follow-up audits if required to ensure corrective measures are completed appropriately. The correct support at the correct time offers a superior strategy – one that is far more cost effective and reliable.
References 1. Brown 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 Brown EG Preparing for a European pharmacovigilance regulatory inspection. Pharmacoepidemiol Drug Safety 2002 11 S238