Download our self-assessment audit checklist
The recently-revised European pharmacovigilance regulations shift the emphasis of the audit process to the marketing authorisation holder. Now you must assess your own pharmacovigilance systems – including carrying out risk-based audits.
According to Steve Jolley, author of Whitehall Training’s online pharmacovigilance courses, the recent shift to self-auditing has become one of the biggest concerns for MA holders.
This article from Whitehall Training, summarises the key aspects that you must consider to carry out your own Pv audit. We have also included a more detailed, downloadable checklist so you can easily assess whether you are examining the right aspects of your Pv system in the correct way.
Risk-based approach…
Under the revised legislation, when preparing for an inspection from a European regulatory agency, your Pv system audits must use a risk-based approach. In other words, they must clearly define areas of the highest risk to your organisation’s pharmacovigilance system. The term “risk” is used here to mean the probability of an event occurring that will have an impact on the achievement of objectives. Factors like the severity of its outcome and/or likelihood of it remaining otherwise undetected also play an important role. Clearly the risk to public health is of paramount importance.
Risk is assessed at three levels – strategic, tactical and operational. To successfully implement a risk-based approach, auditors should use their assessments of each risk as a basis for the strategic, tactical and operational planning of audit activity.
Strategic risk planning…
This concerns long-term audit activities – usually covering a period of 3-5 years.
Your strategy should list all possible audits that could be performed as well as including an assessment of risk, resources and training needs. The purpose is to outline the areas highlighted for audit, the audit themes, and the methods and assumptions on which the audit programme is based.
Your audit strategy should cover the governance, management of risks and internal controls of all parts of the pharmacovigilance system. It must make allowance for organisational and staffing changes as well as acknowledging the outcomes of previous audits.
Download the Pharmacovigilance Audit Checklist for a more detailed list of aspects that should fall under the term, “Strategic Risk” in your audit process.
Tactical risk planning…
This comprises a series of one or more audits planned over a shorter timeframe – usually one year.
It is important to make sure that your programme of risk-based audits is approved by the head of the organisation and is supported by an appropriate risk assessment. Clearly, the programme should focus on the areas you have identified as high risk. However, it should also compensate for areas that may have received insufficient attention your under past audits. You should keep it sufficiently flexible to accommodate specific requests from management and those responsible for the organisation’s pharmacovigilance activities.
You must document the scope, objectives and timing of each audit within the programme. These details should stem from a risk-assessment. However, regardless of the risk-assessment, risk-based pharmacovigilance audits should be performed at regular intervals to assure that your system complies with the legislative requirements.
Download the Pharmacovigilance Audit Checklist to check that your audit is covering the right things under the term, “Tactical Risk.”
Operational risk planning…
It is vital that the conduct of planned audits follows written procedures and is in line with the risk-based audit. You must also define timeframes for all the steps required.
Reporting is an essential part of the process. The auditor’s findings must be recorded in a written report and communicated promptly to your senior management. Mechanisms must be in place to ensure that not only are audit findings and recommendations relayed to your organisation but also that you have the opportunity to relay feedback to the auditor. The way and speed in which information is transferred must be dictated by the relative risk level – hence the need for a grading system (defined in the Pv quality system) to reflect relative criticality of individuals risks. Serious concerns requiring urgent action must be communicated promptly to your senior management (as well as the auditor’s management, if they are different).
At the simplest level, weaknesses can be split into critical, major and minor:
Critical weaknesses – fundamental weaknesses within your Pv process that can affect the entire system. They may affect the safety, well-being or rights of patients, or could even pose risk to public health. The audit should recommend measures to address these issues, and these would normally require your organisation to act immediately.
Major weaknesses – substantial weaknesses in one or more of your Pv processes or a single weakness that adversely affects your entire Pv system. Major weaknesses may also affect the safety, well-being or rights of patients, pose risk to public health. However, in these cases, the effect is not considered serious. Again, the audit should recommend measures to address or reduce the impact of the issues, but they require your organisation to act promptly rather than immediately.
Minor weaknesses – relatively insignificant issues that are not expected the have an adverse effect on your Pv system as a whole or adversely affect patients and the general public. The audit should recommend actions to fix minor weaknesses that your organisation should be adopt within a reasonable time.
Download the Pharmacovigilance Audit Checklist for a more detailed list of aspects of your audit that fall under the term, “Operational Risk”.
Blog Author: Dr. P.V. Practice
www.whitehalltraining.com
Whitehall Training provides online training courses developed to meet the learning needs of both the clinical and pharmaceutical sectors. Clients range from clinical research doctors and nurses to international Pharma companies and CROs.
Students develop their skills and earn CPD points with industry-recognised compliance training. Trainers and administrators save time by assigning and managing licences with our easy-to-use admin system.
To date we have trained over 21,000 students across 40 plus countries.
Course Author: Steve Jolley
Steve is the author of a 4-module online pharmacovigilance course available through Whitehall Training. He is a subject matter expert in all areas of global safety compliance and signal detection, and is a frequent speaker at leading industry events with FDA and MHRA on the topics of auditing and signalling. For more information visit www.sjpharmaco.com.
