Voluntary GDP Certification: the case for why "getting a GDP certificate" is not as easy as it sounds

Increasingly, more Dutch transport companies transport medicinal products and want to have a GDP certificate to reassure their customers that they have implemented measures to safeguard quality and safety. That is reasonable. Yet, in many cases, these expectations do not fit from the outset: “We do not store medicinal products for more than 72 hours, so we don’t have to meet the GDP regulatory requirements.” This assumption is understandable, but not correct.

"No license" does not mean "no requirements"

However, even in cases in which a GDP license isn’t required, the fundamental question remains the same: Can you demonstrate that your procedures ensure the quality of medicinal products during transportation? Voluntary GDP certification ensures that you are implementing the applicable GDP regulations regardless of whether a GDP license is required or not.

Transporting medicinal products is not “simple.” In fact, many key risks occur during transport, which have to be controlled, like:

• temperature control and monitoring,
• deviations and incidents during transport,
• cleaning, maintenance, and qualification of vehicles and equipment,
• security against theft, tampering, etc.,
• traceability, documentation, and data integrity,
• complaints, recalls, and escalation procedures.

An audit of your company’s GDP implementation is an examination of evidence, not intentions

The key in a GDP audit is not only what you want to do, but what you can demonstrate:

• procedures consistent with daily operations,
• evidence that procedures have actually been followed,
• documented training and competence of personnel,
• logical and up-to-date risk assessments,
• follow-up of deviations and improvement actions.

If these basic elements are missing, major findings can be anticipated, as well as a delay in the certification process until corrective actions are taken.

The greatest underestimation: practice what you preach and keep it up!

The biggest effort for many transport companies is not the audit day or the implementation of the quality system, but rather living up to the standards you set in the quality system. As well as the motivation to do it; how do you keep yourself motivated to keep implementing these strict GDP standards in a challenging market where time and rates are always under pressure.

Here, PCS can help – not to produce paperwork, but to implement a process that will actually work in the day-to-day operations and be maintainable. Making a clear distinction between what you actually need to implement the GDP and what would otherwise be a time-wasting activity.

Cost of voluntary GDP certification

Costs depend on your scope, the maturity of your QMS, and the number of vehicles and locations. You should realistically expect to implement/create;

• a gap analysis and improvement plan
• procedures and records
• risk assessments and, where required, validation/qualification
• training and practical implementation
• audit preparation and follow-up of findings

The audit is usually the final step—not the starting point.

Conclusion

A voluntary GDP certificate has real value, but it is not a formality. GDP certification means demonstrable control over risks, processes, and people. That requires preparation, discipline, and usually more effort than initially expected.

If you want a clear picture of where you stand and what is truly required, start with a focused gap analysis and build a realistic plan toward audit readiness. This prevents surprises, delays, and unnecessary costs. Get in touch with PCS so we can help you in this exciting project.