Ten Common Misconceptions in GDP Implementation Clarified

Good Distribution Practice (GDP) is a critical component in the pharmaceutical supply chain, ensuring that medicines maintain their quality and integrity from manufacturer to patient. However, implementing GDP guidelines can be complex, and misconceptions often arise. The Dutch Healthcare Inspectorate (Inspectie Gezondheidszorg en Jeugd, IGJ) has addressed several of these misunderstandings in their Q&A whitepaper on GDP.

In this blog post, we’ll explore the top 10 common misconceptions in GDP implementation and provide clarifications based on the IGJ’s guidance. As a leading training institution specializing in GDP and Responsible Person (RP) training PCS adopts these principles in it’s consultancy, audit and training services.

1. Misconception: A Wholesale License Is Not Required If You Don't Own the Medicines

Clarification: Even if your company stores medicines without owning them, you may still require a wholesale license. According to the IGJ, if you store medicines for longer than 72 hours, you must have a wholesale license in the Netherlands. This applies regardless of ownership because the activity involves holding stock, which is regulated under GDP guidelines.

2. Misconception: GDP Guidelines Apply Within Intramural Institutions

Clarification: GDP guidelines apply up to the door of an institution such as a hospital or clinic. Once medicines enter the institution, the responsibility for proper management and storage falls on the institution itself, not under GDP but under specific regulations applicable to healthcare providers.

3. Misconception: Manufacturers Don't Need a Wholesale License for Trading Within the EEA

Clarification: If a manufacturer trades medicines sourced from suppliers within the European Economic Area (EEA), they must obtain a wholesale license in addition to their manufacturer license. Trading activities, whether physical or financial, are considered wholesale activities under GDP regulations.

4. Misconception: A Wholesale License Allows Importing Medicines from Outside the EEA

Clarification: Importing medicines from outside the EEA requires a manufacturer license, not just a wholesale license. Import activities are strictly regulated to ensure that all imported medicines meet EU standards for quality and safety.

5. Misconception: Wholesalers Can Store Investigational Medicinal Products (IMPs)

Clarification: IMPs fall entirely under the responsibility of a manufacturer. Wholesalers, including contract warehouses, are not permitted to store or transport IMPs. The storage and distribution of IMPs must comply with specific regulations that are outside the scope of GDP.

6. Misconception: GDP Guidelines Apply to Medical Devices

Clarification: Medical devices are regulated under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), not GDP guidelines. While both sets of regulations aim to ensure product quality and patient safety, they have different requirements and scopes.

7. Misconception: Transporters Always Need a Wholesale License

Clarification: Transporters who only transport medicines and store them at one location for less than 72 hours do not need a wholesale license in the Netherlands. However, if they store medicines for 72 hours or longer, a wholesale license is required. Regardless of license requirements, all transporters must adhere to GDP rules related to transportation.

8. Misconception: Mean Kinetic Temperature (MKT) Can Justify Temperature Deviations

Clarification: MKT should not be used to compensate for inadequate temperature control during storage or transport. The IGJ emphasizes that MKT cannot replace proper temperature monitoring and control. Wholesalers must ensure that medicines are stored and transported within the temperature ranges specified by the manufacturer.

9. Misconception: Medicines Don't Need Physical Separation in Storage

Clarification: Medicines must be stored in separate, clearly marked areas that are only accessible to authorized personnel. This physical separation is crucial to prevent mix-ups and contamination, ensuring the quality and integrity of pharmaceutical products.

10. Misconception: Brokers Don't Need to Comply with GDP or Have a Quality System

Clarification: Brokers must comply with GDP guidelines as outlined in Chapter 10 of the GDP guide. They are required to have a quality system in place and must register with the appropriate authorities, such as Farmatec in the Netherlands.

Why Understanding These Clarifications Matters

Misconceptions in GDP implementation can lead to non-compliance, regulatory actions, and risks to patient safety. By understanding the correct interpretations of GDP guidelines, companies can ensure that they are meeting all legal requirements and maintaining the highest standards of quality in the distribution of medicines.

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Navigating the complexities of GDP regulations requires thorough knowledge and practical experience. As a specialized training institution, we offer comprehensive GDP and Responsible Person training courses designed to equip you with the necessary skills and understanding to ensure GDP compliance.