Storing medicines comes with responsibilities, especially if you store them for longer than 72 hours. In the Netherlands, a wholesale license is required for long-term storage, and with it compliance with Good Distribution Practice (GDP) guidelines. But what exactly do these guidelines entail, and how do you ensure that you are fully prepared for inspections? In this blog, we discuss what is involved in storing pharmaceuticals and how to organize it properly.
How do you comply with GDP guidelines for drug storage?
Read how Dyzle ensures secure and validated data storage for the pharmaceutical and healthcare industries
What do GDP guidelines mean for your organization?
GDP guidelines were created to ensure the quality of medicines during storage and transport. For organizations with a wholesale license, these guidelines form the basis for a quality management system that validates and documents processes. This includes, for example, ensuring proper storage temperatures, conducting temperature studies and maintaining detailed documentation.
Complying with these guidelines is essential not only for the quality of your products, but also for maintaining your license. Control by the Health Care and Youth Inspectorate (IGJ) increasingly focuses on how organizations comply with GDP guidelines.
The importance of a Master Validation Plan
A Master Validation Plan (MVP) plays a central role in following GDP guidelines. It defines all the processes and procedures that contribute to the validation of your storage areas, temperature monitoring and critical control points.
With an MVP, you not only identify risks but also document how they are controlled. It provides insight into how consistency is ensured and how deviations are resolved. This makes it easy for you and regulators to assess whether your practices comply with guidelines.
Why a reliable partner is important
Following GDP guidelines can be challenging, especially if you do not have the necessary knowledge or resources. An experienced partner can support you in implementing a validation system, creating an MVP and preparing for audits.
A good partner not only thinks with you, but also provides scalable solutions that fit your specific situation. Whether it involves temperature studies, calibration or implementing temperature monitoring, a committed partner makes the process clear and manageable.
Conclusion
GDP compliance requires a structured approach and careful validation of your processes. With a well-drafted Master Validation Plan and the support of an expert partner, you will ensure that your storage and transportation processes comply with all guidelines. This provides assurance not only for your organization, but also for your customers and regulators.
Do you have questions about temperature monitoring in correlation with GDP guidelines? Contact our validation engineers for a free consultation.
