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Good Pharmacovigilance Practices: Open the Doors to the EU

February 10th, 2015 by

EU Good Pharmacovigilance PracticesThe pharmaceuticals you manufacture have massive potential. On one hand, they could represent a vital cure for struggling patients, but they might also cause someone to experience serious health complications. The quality of your products can’t be left to random measures, particularly in cases where something goes wrong with the production process. Implementing Good Pharmacovigilance Practices (GVP) helps you to catch safety breaches early, before they cause major issues.

Of course, GVP isn’t just a moral duty enacted by responsible manufacturers who want to improve their production facilities. In territories within the EU, GVP is essential to marketing your products, and it’s critical that you identify the appropriate guidelines when devising compliance strategies.

Where Are Good Pharmacovigilance Practices Defined?

The European Medicines Agency publishes and maintains GVP standards in the EU. These measures are designed to facilitate and partially standardize the way firms perform pharmacovigilance checks and procedures, but they’re also employed by pharmaceutical regulatory agencies in different EU Member States.

What Do GVP Standards Cover?

A quick glance at the most-recently published GVP guidelines reveals they address a number of topics such as medication errors and the management and reporting of adverse reactions. Some obvious factors, like general pharmacovigilance and risk-management systems, are to be expected. What many firms fail to anticipate is that the guideline also touches on often-overlooked facets of the marketing process, such as post-authorization safety studies and safety communication.

This broad scope means that almost anything you do in relation to your pharmaceutical products could require some form of GVP allowance, and the changes you have to implement may vary widely in complexity. As an example, suppose you decide to bring your standard operating procedures and GVP-mandated pharmacovigilance system master file into the modern era by storing related records and documentation on a networked computer system.

In such a case, you’d also need to become compliant with EU Annex 11’s IT security rules if you want your products to remain marketable.

Where Do You Need to Implement GVP?

Although it’s obvious that your chemical manufacturing facilities require GVP allowances, you can’t simply adopt a piecemeal approach that targets a few specific aspects of your organization as needed. For instance, the marketing teams that create your advertisement copy and write the descriptions and instructions in your medicine packages are just as bound by GVP as your research staff and chemical engineers are.

It’s essential that you implement these practices in a comprehensive fashion that facilitates the easy integration of your entire manufacturing, marketing, distribution and oversight operations. 

So where do you begin when it’s impossible to start everywhere all at once? Most firms initiate their implementation of GVP with a reflective self-assessment. By distinctly identifying the different facilities and processes they engage in on a routine basis, they often find it easier to reference applicable guidance and rules within the GVP annex. 

After discovering which regulations apply to you, it’s simply a matter of learning about industry standards designed to comply and implementing them. This is where GxP-CC comes in. With decades of practical experience helping international firms tailor their pharmaceutical practices to EU markets, these consultants understand how to help you build and maintain a more effective compliance system. Contact them today to plan your first step.

 

 

About this author:

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For over 15 years Mr. Francum has worked in regulated environments directing and orchestrating the various components involved in assuring compliance of the most stringent regulatory requirements. He is an internationally recognized expert and has extensive experience in over 25 countries including, but not limited to, the regions of North America, Latin America, Europe and the Middle East.

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