The Quality Review of Documents (QRD V9) update came into effect on January 28, 2022. The new version consists of a set of guidelines established by the European Medicines Agency (EMA) outlining the responsibilities and duties of those who ensure the quality of veterinary medicines. The update to V9.0 includes several key changes aimed at improving the overall quality of veterinary care and prioritizing animal welfare.
With that said, the effort to convert products to comply can be overwhelming at first when following a traditional track changes/copy-and-paste approach. Partnering with a vendor with the appropriate technology can help to simplify the approach, potentially minimize human intervention, and focus the manual effort on ensuring the highest-quality update.
Ultimately, the best starting point is having a well-rounded understanding of the guidelines, since they can be complex. Identifying a partner who is thoroughly familiar with these regulatory shifts is therefore essential. To start, let’s assess some of the key components of the QRD and then look at preparation for ensuring a seamless transition.
Key Guidelines from the QRD
Quality Management System
The regulation requires the implementation of a quality management system to ensure that veterinary medicines are manufactured and distributed according to the relevant regulations and standards.
The guideline emphasizes the use of real-world data to support the approval and post-approval monitoring of veterinary medicines. The qualified person (QP) is responsible for evaluating and interpreting real-world data and ensuring that it is properly documented and reported.
The QP will be required to oversee the design, conduct, and reporting of clinical trials to ensure that the results are reliable and that the study protocols follow ethical standards.
The QRD V9.0 requires the QP to verify that each batch of veterinary medicine produced complies with the relevant regulations and standards before release. The QP must also ensure that adequate quality controls are in place throughout the manufacturing process.
All relevant documents related to the manufacturing and distribution of veterinary medicines are required to be properly controlled and maintained. The QP must ensure that all documents are up-to-date and easily accessible.
Complaints and Adverse Reactions
The QRD V9.0 requires the QP to investigate and resolve any complaints or adverse reactions related to veterinary medicines and to report any significant issues to the relevant regulatory authorities.
How to Prepare for the QRD V9.0: Tips for Success
Understand the Guidelines
The first step in preparing for the QRD V9.0 is to familiarize yourself with the updated guidelines. Read through the guidelines carefully to understand the changes and the expectations of the regulatory authorities.
Assess Your Processes
Once familiar with the guidelines, take a close look at your current processes to determine if they need to be updated. Make changes as necessary to ensure that they align.
Invest in Technology
The QRD V9.0 update places a strong emphasis on the use of technology to improve veterinary care. Consider investing in technology that will help you collect and analyze real-world data, communicate with clients, and manage your patients' medical records.
Invest in Training
To ensure that you are fully prepared for the QRD V9.0 update, seek out training and education opportunities. Attend workshops, conferences, and webinars to learn about the latest developments and to stay up to date on best practices.
The QRD V9.0 update impacts all members of your veterinary team, so it's essential to collaborate and work together to ensure a smooth transition. Hold team meetings to discuss the updates, share best practices, and ensure that everyone is on the same page.
The update of the QRD V9.0 is a significant development in the veterinary industry. Assessing your existing processes and aligning to ensure you are adhering to these guidelines prepares you and your team for the changes and ensures that you are providing the highest-quality care for your animals.
TransPerfect Life Sciences has established a process enabling affected organizations to update their content in accordance with QRD V9.0 either as part of the process or as a proactive step. As part of this, we also provide regulatory consulting and guidance on the best approach for managing content and ensuring compliance with the guidelines.
Concerned about the volume of content requiring updating? We’ve developed a program that will define everything for you and can help you update all your products with an efficient and cost-effective, custom-built process. If you are curious to learn more, contact TransPerfect Life Sciences today to assess and implement a successful compliance strategy.