What is a VMP?
A VMP is a project action plan, which can be used to integrate qualification and validation activities into day-to-day business. It defines the systems and processes that require qualification, outlines the necessary qualification and validation activities, and clearly establishes tasks and responsibilities. Additionally, it provides an overview of the required time, capacity, and frequency for these activities.
Requirements
A VMP is not explicitly required, but planning and implementation of process validation is a result of numerous international standards such as ISO 13485 and the requirements of the FDA, MDR and IVDR. The VMP ensures product safety during production, logistics, and storage processes. It also covers contract manufacturing, ensuring that all qualification and validation requirements are met. Crucial to the successful implementation of the plan is management commitment and support.
Challenges
One of the top 10 findings in FDA audits is deviations in validation and qualification processes. One reason is the distance between Quality Management/Regulatory Affairs and Production. Many companies face challenges due to a lack of knowledge of regulatory requirements, which makes it difficult to implement the regulations correctly. In addition, there is often a limited understanding of manufacturing processes within QM/RA. To address these challenges, it is essential to provide qualified personnel and to implement effective project management to enable continuous planning and smooth execution.
Get ready to start!
Need help? A few recommendations for successful planning and implementation: Start by analysing your manufacturing system to gain a deeper understanding of your processes and identify any potential weaknesses at an early stage. A thorough risk analysis will help you determine the impact on product quality and safety. In addition, it is important to ensure that your staff are not only qualified but also available to carry out their tasks and responsibilities. Plan your sales activities in advance and integrate them into your daily workflow to ensure efficient execution. If you have any questions or need support, please do not hesitate to contact us.
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