Difference in distribution inspections of medicines and medical devices

The key difference in the GDP (Good Distribution Practice) inspection for medicines and medical devices distributors lies primarily in the legislation and requirements that apply to each category, which also impacts the inspection process. Here’s an overview of how they differ: by Sandra Hillaert

Medicines (Pharmaceuticals):

The EU GDP Guidelines for medicines are clearly defined in Guidelines 2013/C 343/01 (human medicines) and Regulation 2021 1248 (veterinary medicines), which outlines the detailed expectations for the distribution of medicinal products. These guidelines are structured into ten chapters, which cover a wide range of requirements including storage, transportation, traceability, quality assurance, personnel and handling of complaints, returns and recalls.

Distributors of medicines must obtain a Wholesale Distribution Authorization (WDA) from the relevant national authority. This requires a specific inspection of the distributor’s operations, ensuring they comply with the comprehensive GDP framework. These compliance inspections are generally more thorough and structured, given the detailed and prescriptive nature of the guidelines. These inspections tend to focus on ensuring that these processes are followed correctly.

Medical Devices:

For medical devices, the relevant regulations are the EU MDR (Medical Device Regulation)? and the IVDR (In Vitro Diagnostic Regulation), which do not have a dedicated section for distribution practices. The absence of detailed and structured guidelines for medical device distribution means that the regulations are more general compared to pharmaceuticals. The MDR and IVDR state that distributors must ensure that while the device is under their responsibility, storage and transport conditions must comply with the manufacturer’s specifications. This is why, in some countries (like Belgium), guidelines for good distribution practices for medical device distributors have been developed separately, often in consultation with industry groups. These guidelines may include practices similar to those for pharmaceuticals, but they are not as robust or standardized across the EU. Unlike pharmaceuticals, distributors of medical devices are not required to hold a specific license such as the WDA. Some national authorities (like Belgium) only require a registration. This registration is usually simpler and does not require the same level of detail as a WDA.

In an inspection, the focus is on verifying adherence to the manufacturer's storage and transport conditions. A checklist, often based on guidelines developed by national authorities, is used to assess compliance.

An important difference is the requirement of materiovigilance for distributors of medical devices. The purpose of materiovigilance is to study and follow incidents that might result from using medical devices. It enables dangerous devices to be withdrawn from the market and to eliminate faults in medical devices with the intention of constantly improving the quality of devices and providing patients and users with increased safety. The process for the handling of incidents will be looked at during an inspection.

For pharmaceutical distributors that already have a WDA and a Quality Management System in place, medical device inspection tend to result in fewer observations, as the same systems generally cover the medical device guidelines as well. However, for distributors that do not have pharmaceutical experience, the inspection may be more challenging as they may not have systems in place to fully comply with even the basic distribution requirements for medical devices.

Conclusion

While both medicines and medical devices distributors are inspected by national authorities for compliance with their respective regulations, the key difference in the inspection process lies in the clarity of guidelines, the licensing requirements, materiovigilance, and the comprehensiveness of the inspection. Pharmaceutical distributors tend to face more prescriptive inspection criteria, while medical device distributors may experience a more flexible, albeit less standardized, inspection process. However, both sectors ultimately share a common goal—ensuring the safe and compliant distribution of products to end-users.

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