GDP & it’s Vital Role in the Storage & Distribution of Clinical Trial Materials
Clinical trials are an important part of the drug development process, requiring careful planning and execution to ensure the safety and efficacy of the drugs being tested.
Good Distribution Practices (GDP) is an essential part of this, guaranteeing quality standards and guidelines govern the storage, transportation, and distribution of pharmaceutical products.
The strict standards and guidelines that govern GDP ensures that clinical trial materials are:
Stored under appropriate conditions given clinical trial materials often have specific storage requirements, such as temperature and humidity conditions, to maintain their stability. GDP ensures that storage facilities are equipped with appropriate infrastructure, including temperature-controlled environments, to meet essential requirements.
Properly packaged as adequate packaging is essential to protect clinical trial materials from physical damage and external influences during transportation. GDP guidelines define standards for packaging materials, labelling, and documentation, ensuring that materials remain intact and identifiable throughout the supply chain.
Tracked and documented; traceability and documentation play a crucial role in clinical trial material storage and distribution. GDP mandates accurate record-keeping, including batch numbers, expiration dates, and storage conditions. This information enables proper inventory management and ensures the integrity and authenticity of materials.
The strict governance of GDP ensures clinical trial materials are handled to meet the above conditions and minimise the risk of degradation or contamination, essential for maintaining the integrity of clinical trial materials throughout their lifecycle.
BS3 provides full clinical trial support, including validated storage and distribution of the investigational drug, as well as reverse logistics to manage the return and disposal of supplies at the end of the trial.
BS3 is ISO9001-2015 certified and adheres to GDP and GWP guidelines, ensuring strict standards are always followed and the investigational drug is properly handled, stored, processed and delivered to the clinical trial sites to schedule and in the most efficient manner. Contributing to the vital role of assisting to the overall quality of the clinical trial and increasing the chances of success in the drug development process.
In addition to this, BS3’s reverse logistics services ensure that any unused drug supplies are properly disposed of, or repurposed in compliance with regulatory requirements. BS3 currently services clients across S3, 4 and 8 trials.