Have You Been Inspected by the MHRA?

Mark James

By 2017-04-13

The Medicines & Healthcare products Regulatory Agency (MHRA) is the UK’s primary regulatory body for the pharmaceutical and medical device industry. Every year, this agency inspects dozens of companies for compliance with government regulations.

The Medicines & Healthcare products Regulatory Agency (MHRA) is the UK’s primary regulatory body for the pharmaceutical and medical device industry. Every year, this agency inspects dozens of companies for compliance with government regulations. In some cases, the inspections are triggered by a report or incident—but in many cases they are completely random. Many of these inspections turn up violations, often from companies that thought they were in full compliance. And once a violation is spotted by an inspector, the fallout can be much more expensive than it would have been to simply fix it in advance. That’s why so many of the leading medical companies rely on pharmacovigilance compliance consulting. They keep their organization in compliance from the outset, to avoid expensive problems later.

The most recent MHRA pharmacovigilance inspections report is a great example of this. In a twelve-month period, the MHRA conducted a total of 48 pharmacovigilance inspections. You might expect that this would have turned up less than 48 violations—but the truth is quite the opposite. These inspections turned up a staggering 351 violations. The majority of these were deemed either “major” violations or “critical” violations, each of which can bring major regularity backlash and expensive penalties, in addition to the cost and difficulty of fixing the violation itself. Once a company has these types of violations, it is likely to be re-inspected the following year—potentially revealing a new wave of unintended violations.

At SJ Pharma Consulting, we work to help keep your company off this list. Our pharmacovigilance compliance consulting gives you a range of options to assess your own operation and reach 100% compliance in advance of an inspection. We offer:

Online training. Many companies choose our cost-effective, high impact online compliance training. The advantage of an online training is you can easily put as many staff through it as you like. We will help your staff understand the regulations affecting your work, especially areas where companies commonly have unintended violations. We will equip them to identify and fix any problems in your compliance.

In-person training. The in-person training gives an on-the-ground instructor presence. It allows staff to get more in-depth feedback and personal, one on one time. It is the favorite choice of many of our customers.

A full pharmacovigilance audit. For those companies that will tolerate no expensive violations, a full pharmacovigilance audit is best. SJ Pharma has a custom 50-page checklist to make sure every aspect of your organization can pass an inspection, every time.

The MHRA found 42% more “critical” violations in the 2014-2015 report than in the previous year. This is widely seen to reflect more intensive scrutiny from regulators. There has never been a more important time to focus on compliance. How can SJ Pharma Consulting’s pharmacovigilance compliance consulting help you?