4 common GDP pitfalls and how to avoid them

Avoid GDP pitfalls

1 Jun

By Tina Nørgaard

The benefits to the business in rigorous GDP compliance are multiple: In addition to maintaining the licence to operate, compliance with quality parameters are an efficient management tool.

However, as an RP through more than 20 years I have noticed that pharma companies and their supply partners often overlook these four essential elements of the GDP work:

Good Distribution Practice (GDP) is the set of rules pharma companies and their supply partners such as wholesale distributors must comply with in order to handle medicine in a safe and compliant way.

1. Anchoring distribution quality management in the organisation

Underestimating the importance of working systematically with GDP across the organisation is the root cause of most GDP problems I have witnessed.

The amount of documentation and the time necessary to proper GDP distribution quality management may seem excessive if you have not fully acquainted yourself with the GDP legislation. But GDP guidelines hold answers as well as suggestions on how to efficiently manage distribution quality.

Deeply anchoring the understanding of the guidelines and their importance in the organisation helps you foresee and mitigate risks and deviations which could harm your business and, ultimately, jeopardise patient safety.

2. Making GDP compliance a management priority

While specific GDP tasks can be outsourced to external providers such as PharmAdvice, the compliance responsibility remains firmly with the management of the company.

I recommend you view the quality management system (QMS) mandated by the GDP guidelines not as a tiresome duty but as an efficient management tool to ensure quality throughout your supply chain. If quality management is highly prioritised at management level, this attitude trickles down through the organisation, resulting in better practises, smoother operations and fewer findings during inspections.‍ ‍

By contrast, the authorities view a lack of management engagement in the GDP process as a red flag, often prompting further scrutiny.

3. Using the QMS systematically

When companies happily tell me they have no deviations, I immediately want to investigate whether the purpose of the quality work is being achieved. ’No deviations’ is not the main goal of distribution quality management, nor is it necessarily a testament to a perfect GDP process. Rather, it may be a sign that the organisation is not using their QMS systematically and has failed to detect and/or document deviations.

The systematic documentation throughout the supply chain of a medicinal product is crucial to ensuring patient safety. If, for instance, a patient experiences unusual side effects, you must be able to unravel the entire product journey like a ball of yarn, retracing the medicinal product’s path in an unbroken chain of documentation from the medicine reaching the patient to the earliest clinical trials until you find the reason.

4. Setting aside an annual budget for GDP

GDP compliance is an on-going process, not a one-off project, and a budget should be allocated to GDP compliance every year.

I see the QMS as a dynamic tool. SOPs must be continuously updated to reflect changes in legislation and practices, and staff must be trained annually. Processes must be monitored, deviations documented, inspections and audits handled every year.

In short, achieving and maintaining GDP compliance requires more than a licence and a few SOPs. It takes continuous attention, structured documentation and strong organisational anchoring, from top management to day-to-day operations.

Steer clear of the pitfalls with experienced support

If you're unsure whether your current setup meets the requirements, or if you're preparing to enter the Nordic markets, we'd be happy to support you. At PharmAdvice, we offer tailored GDP and RP services based on decades of experience with distribution quality management.

Get in touch to discuss how we can help ensure your GDP system is solid, compliant and serves your organisation’s quality objectives.