Postmarketing (PV) Auditing Services
Pharmacovigilance audits are a vital part of any pharmaceutical company’s Quality Management System. They need to be carried out periodically, but most importantly correctly. Auditing should provide an unbiased view of the operational performance of a Pharmacovigilance system. It should measure the system against its own procedures and see how well it is aligned with the regulatory requirements and guidelines. Accurate audits ensure that the system itself remains effective and compliant with the regulators.
Why good Pharmacovigilance Audit practices are so vital?
Statutory PV inspections by regulators have become increasingly obtrusive and wide in scope within recent years. GVP Modules III (PV Inspections) and Module IV (PV Audits) provide detailed requirements to produce a robust auditing program by a Marketing Authorization Holder.
An effective PV audit system helps a company identify and fix any compliance issues in a cost-effective and efficient manner. Most importantly it allows a company to avoid punitive damages and costly demands by the regulators.
Audit Know-how You Need for Postmarketing Pharmacovigilance
The goal of a pharmacovigilance (PV) audit is to use impartial evidence to evaluate and assess the correctness and effectiveness of the execution and operations of a PV system.
At Gemini Group, we offer professional PV auditors who are both unbiased and autonomous when reviewing your PV system. Our PV auditors are EU Qualified Persons for Pharmacovigilance (QPPVs) and have tremendously strong backgrounds in PV within global markets, so that they are fully competent in all PV legislation and recognize the practical characteristics of its implementation.
Three Pronged Risk Based Approach
As mentioned above, PV Audits are conducted to minimize risk and identify problems that may exist within a drug safety program. However, at Gemini Group we believe that a company should seek expert unbiased advice in order to properly develop and implement three critical components within their auditing process.
1. Long term strategic planning
We highly recommend that a company thinks long term and produces a 3 to 5 year high-level plan that clearly specifies audit schedules, topics to be examined, and various methods or techniques that will be utilized. This strategic planning should speak to all characteristics of drug safety work, including:
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All known processes and scheduled activities
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A detailed quality management system which provides the backbone for these processes and activities
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Qualified person who will act as the liaison between the company and external parties
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Qualified person who will be the point of contact for regulatory authorities
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Risk mitigation procedures
2. The Creation of a Multifaceted Auditing Program
We recommend creating a robust and detailed 18-month plan, which will form the basis of your audit program. This plan should include:
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The principles, structure, and best practices to followed
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Address pain points that have required further input in the past
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Identify higher risk potential areas
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A detailed QC program that offers checks and balances
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A precise schedule in which these tactical audits must take place
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Ensure all practices are compliant
3. Isolated Audits
Each audit must be properly documented and specific. Every step needs to be documented and the best practices used should be clearly represented.
Extensive Knowledge for Postmarketing Auditing
Our PV audit capabilities are all encompassing, covering not only PV, but also regulatory sciences, medical information, clinical, quality, and commercial departments.
Gemini Group PV auditors are an indispensible addition to your quality management system and help satisfy the requirements of applicable regulations, guidelines and standards. We make sure that you are always ready for an inspection. Our team has significant experience in conducting remote or on-site audits across all parts of your PV system. This can include audits of your company headquarters, affiliates, license partners, service providers, and distributors. We can of course also audit a range of specialized topic-specific areas to meet your business needs (e.g., case processing, aggregate reports, RMP and risk minimization, contractual partners, QMS, and PSMF).
In line with GVP Module IV and mentioned above, Gemini Group can help implement a risk-based approach to PV audits. We will create an appropriate audit strategy, effective audit program, and robust CAPA management system.
To help companies become inspection ready, our PV consultants provide targeted inspection readiness training, facilitate interactive interview practice, and advise on technical legislative requirements.