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First PV Inspection for Red Line
In February, Red Line Pharmacovigilance was inspected by the Medicines and Healthcare Regulatory Agency (MHRA), the UK’s regulatory ‘watch-dog’ for monitoring the safety, quality and performance of all medicines and medical devices.
As a pharmacovigilance and medical information outsourcing provider, Red Line Pharmacovigilance Ltd performs a pivotal role for pharmaceutical companies, managing all aspects related to safety, which includes any potential or actual harmful adverse effects caused by a medicinal substance. This process assists companies to constantly monitor the benefit-risk profile of their products, ensuring that the benefits of a medicinal product always outweigh any potential risks to the patient.
The MHRA Pharmacovigilance Inspectorate forms part of the Inspections and Standards Division of the MHRA and inspections are a way of assessing a company’s compliance with UK and EU legislation. Inspections are risk-based, determined following the completion of a ‘Compliance Report’ circulated to Marketing Authorisation Holders every 2 years. An organisation’s risk is determined using the compliance report, previous inspection history and reviewing internal organisational changes, thereby providing an overall risk assessment score. Inspections are then prioritised for companies with the highest risk assessment scores.
The inspection process has changed in recent years, with regulatory authorities taking a more ‘collaborative’ approach when identifying deficiencies within the company systems and procedures. Deficiencies are graded as critical, major and other. Critical findings are referred to the MHRA’s Pharmacovigilance Inspection Action Group (PIAG) for further recommendations on possible enforcement action required.
Every year the MHRA publish a ‘Pharmacovigilance Inspection Metrics Report’ which provides a summary of the inspection findings from the previous year. During the period, 1st April 2011 to 31st March 2012, the majority of critical findings were related to the control and maintenance of reference safety information, which includes documents such as the summary of product characteristics (SPC), patient information leaflets (PILs), investigator brochures and company core safety information (CCDS). It’s important to note that pharmacovigilance plays a key role in contributing to various safety sections of these reference documents, a fact that many SMEs do not fully understand. As such, a good working relationship between pharmacovigilance and regulatory affairs is of utmost importance to ensure critical findings are avoided.
Other key areas where critical findings are identified include case processing, PSUR production, on-going safety evaluation (signal detection), contractual agreements with third parties and/or licensing partners. Overall, the number of findings by the inspectorate has decreased dramatically since 2006, which is promising for the industry and shows regulators that companies are committed to the pharmacovigilance process.
At Red Line Pharmacovigilance Ltd, we see our first MHRA inspection as a milestone. Whilst the pre-inspection build up and preparation stages can be stressful, an inspection does offer a unique training opportunity for staff. The post-inspection de-brief should encourage staff to share their experiences and to identify key learning objectives.
The final outcome report and findings provide a good focus for the future development of the company and assists in providing a good platform for further client discussion. At Red Line we are fortunate to have a range of clients who value a good working relationship and embrace the ‘open-door’ policy we keep. We believe it is vitally important for the QPPV to foster a good working relationship with the MAH; it’s a key component that underpins the entire PV system.
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