GDP compliance checklist: what you need for audits

What is GDP compliance?

As a result, essentially, GDP compliance means that your organisation demonstrably complies with the European guidelines for the distribution of medicines. In the Netherlands, the Healthcare and Youth Inspectorate (IGJ) supervises compliance.

Specifically, GDP compliance revolves around four pillars:

1. Likewise, Reliable measurement data — continuously measuring temperature and humidity with calibrated sensors
2. In addition, Alarms + follow-up — any deviation must have a documented action plan
3. Accordingly, Traceability and audit trail — all data must be irrefutable, immutable and exportable
4. For instance, Consistent reporting — standardised reports across multiple locations and periods

Who do the GDP guidelines apply to?

After all, in practice, the GDP guidelines apply to every organisation involved in the distribution of medicines:

• For example, Wholesale distributors of medicines (mandatory GDP licence)
• In fact, Hospitals and hospital pharmacies
• In contrast, Public pharmacies
• In other words, Logistics service providers (3PL) for pharmaceutical products
• However, Manufacturers of medicines (for distribution activities)
• Additionally, Importers of medicines from outside the EEA

However, Important: Every organisation holding a wholesale licence is required to appoint a Responsible Person (RP) who is ultimately responsible for compliance with the GDP guidelines.

The complete GDP compliance checklist 2026

Additionally, use the checklist below to assess your GDP readiness before your audit.

1. Quality Management System (QMS)

• All in all, Documented quality policy in place
• Furthermore, Procedures (SOPs) for all GDP-critical processes
• Moreover, Responsible Person (RP) appointed and registered with IGJ
• Subsequently, Annual management review planned and conducted
• Above all, CAPA system (Corrective and Preventive Actions) operational

2. Personnel and training

• On the other hand, All employees trained on GDP procedures
• Meanwhile, Training records maintained and up-to-date
• In particular, Job descriptions documented
• Consequently, Hygiene and conduct rules communicated

3. Premises and facilities

• As a result, Storage areas suitable for the products (ambient, cool, refrigerated)
• Therefore, Temperature mapping carried out and documented
• Notably, Separate storage zones for quarantine, rejected and approved product
• After all, Access control in place and logged
• At the same time, Pest control documented
• As a matter of fact, Cleaning schedules in place and signed off

4. Temperature monitoring

• Equally important, Continuous temperature monitoring active at all critical points
• Similarly, Sensors calibrated with a valid calibration certificate
• Specifically, Alarms configured with correct threshold values
• What is more, Alarm follow-up documented (who, when, what action)
• Nevertheless, Audit-ready data export possible (PDF/Excel)
• To illustrate, Data integrity assured (no manual modifications possible)

5. Documentation and traceability

• Likewise, All receipts and deliveries documented
• In addition, Batch traceability per product in place
• Accordingly, Expiry date control operational (FEFO)
• For instance, Returns policy documented
• For example, Recall procedure in place

6. Transport and suppliers

• In fact, Qualified transporters with GDP certification
• In contrast, Temperature during transport monitored (data logger or real-time)
• In other words, Supplier qualifications in order
• However, Contracts with GDP clauses with external parties

7. Complaints and recalls

• Additionally, Complaints procedure documented and active
• All in all, Recall procedure tested (mock recall)
• Furthermore, Notification to IGJ in case of incidents arranged

8. Internal audits

• Moreover, Annual audit schedule in place
• Subsequently, Internal audits conducted and reported
• Above all, Findings followed up with CAPA

Preparing for a GDP audit by IGJ

In fact, importantly, a GDP inspection by IGJ can be announced or unannounced. During an inspection, the inspector will look at:

• Whether your measurement data is correct and reliable
• On the other hand, How you detect and handle deviations
• Whether responsibilities are clearly assigned
• Whether your reports are consistent over time and across locations
• Whether your Responsible Person is demonstrably active

Practical step-by-step plan: 4 weeks before an audit

1. Meanwhile, Week 1: Conduct an internal self-assessment using the checklist above
2. In particular, Week 2: Check the calibration status of all sensors, update training records
3. Consequently, Week 3: Review all deviations from the past 12 months and ensure demonstrable follow-up
4. As a result, Week 4: Compile an audit folder with the key documents (QMS, SOPs, calibration reports, temperature data)

Common mistakes in GDP compliance

For example, based on IGJ inspections, these are the most frequent non-conformities:

1. Therefore, No demonstrable alarm follow-up — alarm goes off, but there is no documented action plan
2. Notably, Expired calibration certificate — sensors have not been calibrated on time
3. After all, Incomplete training records — employees cannot demonstrably prove they were trained
4. At the same time, Temperature mapping missing — storage area has not been mapped
5. As a matter of fact, No separate storage zones — quarantine product is not stored separately
6. Equally important, Manually modified data — audit trail not intact

Temperature monitoring and GDP: what is required?

Moreover, GDP requires that temperature conditions are measured continuously and automatically in all storage areas. Additionally, the minimum requirements are:

• Similarly, At least 1 sensor per 500 m³ of storage space (based on temperature mapping)
• Specifically, Measurement intervals of no more than 15 minutes
• What is more, Automatic alerts when threshold values are exceeded
• Nevertheless, Data storage for a minimum of 5 years
• To illustrate, Annual calibration of sensors with a traceable calibration certificate

As a result, Spotzone offers a complete solution for GDP-compliant temperature registration: view our GDP compliance solution.

10 frequently asked questions about GDP compliance

1. What does GDP compliance mean?

On the other hand, evidently, gDP compliance means that your organisation demonstrably complies with the European guidelines for the correct distribution of medicines. Furthermore, this includes reliable measurement data, alarms and follow-up, traceability and consistent reporting.

2. What are the GDP guidelines?

Accordingly, the GDP guidelines (Good Distribution Practice) are European rules that describe how medicines must be correctly stored and distributed to ensure quality and safety. In the Netherlands, IGJ supervises compliance.

3. Who supervises GDP compliance in the Netherlands?

Subsequently, the Healthcare and Youth Inspectorate (IGJ) is responsible for supervising GDP compliance in the Netherlands. Moreover, they can conduct both announced and unannounced inspections.

4. How do I obtain a GDP licence?

Therefore, a GDP wholesale licence is applied for at IGJ. Consequently, requirements include: a suitable location, a documented quality system, an appointed Responsible Person and demonstrable compliance with all GDP requirements.

5. What is a Responsible Person (RP) in GDP?

To illustrate, the Responsible Person is ultimately responsible for compliance with the GDP guidelines within a GDP-certified organisation. Therefore, this person must have demonstrable knowledge of GDP and be registered with IGJ.

6. How often must I conduct an internal GDP audit?

Specifically, the GDP guidelines require at least one internal audit per year. Similarly, the findings must be documented and demonstrable improvement actions (CAPA) must be implemented.

7. What are the temperature requirements for medicines?

As a matter of fact, most medicines are stored at room temperature (15–25 degrees Celsius), refrigerated (2–8 degrees Celsius) or frozen (below −18 degrees Celsius). In particular, the exact storage conditions are stated on the label.

8. How long must GDP documents be retained?

As a result, gDP documents, including temperature data, calibration reports and training records, must be retained for a minimum of 5 years. Specifically, for some products a longer retention period applies.

9. What is temperature mapping and is it mandatory?

What is more, temperature mapping is a study in which the temperature distribution within a storage area is mapped. Indeed, this is mandatory when commissioning a new storage area and after significant changes.

10. What are the consequences of GDP non-compliance?

In other words, in the event of non-compliance, IGJ may issue a warning, revoke the licence or suspend operations. Notably, non-compliance can also lead to product loss and reputational damage.

How Spotzone helps with GDP compliance

In addition, Spotzone offers a complete, GDP-compliant monitoring solution that keeps you audit-ready at all times:

• Likewise, Continuous temperature monitoring at all critical measurement points
• In addition, Automatic alerts when threshold values are exceeded
• Accordingly, Audit-ready reports on request, exportable as PDF or Excel
• For instance, Data integrity — immutable log
• For example, Calibration management — automatic reminders when calibration is about to expire

In fact, Schedule a free demo and discover how Spotzone makes your GDP compliance easier.