How to align your pharmaceutical supply chain with the crucial GDP demands.
Quality and integrity expectations are soaring in the life science industry. Adhering to Good Distribution Practice (GDP) is as a result crucial for pharmaceutical companies aiming for optimal results in projects, clinical trials, and supply chain management. John Coleman, Business Unit Director at YSDS Life Science, provides insights on achieving GDP compliance and leading the path to pharmaceutical excellence.
The pharmaceutical industry is a stronghold of innovation and progress. It thrives within a tightly regulated landscape, that ensures that every facet of the industry adheres to strict standards and guidelines to secure maximal patient safety. One of the aspects subject to stringent control is the logistics of the pharmaceutical sector, where precision and compliance play a pivotal role in maintaining the integrity of the entire supply chain.
Since 2013, Good Distribution Practice (GDP) has been ensuring that the quality of pharmaceuticals and related products is maintained throughout the distribution network. Failing to comply with these standards can cause regulatory punitive actions to be imposed on your business, putting it at risk for project failure and huge monetary loss.
Decoding the Essence of GDP
Good Distribution Practice (GDP) isn’t just a set of guidelines, it’s the guardian of pharmaceutical quality. It ensures that authorized medicines flow seamlessly through the distribution network, reaching consignees and outlets in their purest form. Compliance with GDP isn’t merely a checkbox; it’s a pledge to uphold EU legislation, maintain temperature intervals, thwart contamination, ensure optimal medicine turnover, and guarantee timely deliveries.
Overcoming Post-Pandemic Challenges
At the heart of Nordic pharmaceutical integrity stands Läkemedelsverket, the Swedish Medical Products Agency. With a vigilant eye, the agency orchestrates audits, including the pivotal audits, to safeguard that pharmaceutical companies align with the rigorous standards embedded in their distribution chains.
The aftermath of the disruptive COVID-19 pandemic has left the life science industry grappling with a backlog of essential audits. As operations resume, companies find themselves thrust back into the limelight of scrutiny, often unprepared and unaware of the intricate details of GDP. The result? Stress and anxiety permeate the industry as the specter of potential audit failures looms.
Being prepared is key for passing a GDP audit.
Mastering GDP Compliance
There are several things pharmaceutical companies must consider in order to ship their products successfully. Here are the three main points to consider.
1. Hire your logistics provider.
Contact a GDP certified logistics provider as soon as possible to:
– Mitigate delays and perform optimal planning through your different phases
– Increase success.
– Allow time for client specific quality agreements, SOPs, audits towards the logistics partner.
Why the emphasis on “as soon as possible”? Because the earlier you can include your logistics provider in your entire supply chain planning, the more effective, robust and cost mitigated it will be.
2. Comply with regulations and demanded documentation.
There are high expectations the pharma supply chain and every regulatory authority interprets the same regulations differently. Ensure that you – for your specific market – know what regulators require, what the latest regulations are and comply accordingly.
Furthermore, comply with providing the right documentation wherever it is required and/or recommended by your logistics provider to ensure an effective customs clearance process. Around 49 regulatory authorities are part of the Pharmaceutical Inspection Cooperation Scheme (PIC/S). They all follow the EU GDP guidelines, making it easy to keep track of what to document.
Please find a checklist of the regulations you need to follow and demanded documentation here.
3. Keep the patient in mind.
Understanding the dynamics of the market and evaluating the administrative complexities involved is essential. Nevertheless, it’s crucial to maintain a patient-centric perspective while doing so, with a focus on practicality and real-world applicability. It’s about empathy, understanding, and a commitment to improving the lives of patients, which is ultimately the core of the life science industry.
A new era of pharmaceutical excellence
Mastering GDP demands isn’t a mere task; it’s a transformative journey demanding a proactive stance and an intimate knowledge of regulatory standards. By embarking on the outlined steps, pharmaceutical businesses not only align with GDP requirements but also carve a path toward real quality and integrity in their distribution networks. This, in turn, contributes to the overarching safety and effectiveness of medicinal products, propelling the industry into a new era of excellence.
About YSDS Life Science
YSDS Science provides global logistics solutions for clinical trials, advanced therapy, biotech, and more. We offer tailor-made GDP-certified solutions for your time and temperature-sensitive products, with full end-to-end visibility. Expect nothing less than 24/7 service from a dedicated team of experts. We offer quality beyond the ordinary.
Visit our website here.
Find your local office here.
