The EU’s New GDP Guidelines for API Distributors
By Bertil Wagensveld, TAPI Global Logistics Director
In the ever-changing pharmaceutical industry, product quality standards must continue to be rigorous to ensure pharmaceutical products that go to market will be safe and effective. Regulatory agencies worldwide have long required drug manufacturers to meet strict guidelines. Now, one region is going a step further by requiring distributors of active pharmaceutical ingredients to meet quality guidelines for distribution.
In 2015, the European Commission enacted new guidelines governing good distribution practice (EU-GDP) for API distributors, the first binding document specifically regulating their distribution activities. The guidelines require API distributors to document how they maintain quality throughout every phase of distribution. The new guidelines ensure that API distributors enhance and document supply chain controls in several areas including quality management, organization and personnel, warehousing and storage, equipment, repacking and re-labeling, and dispatch and transport. They must also now track and record complaints, recalls, returned goods, and the handling of non-conforming materials.
Logistics service providers are now also being asked to meet the required guidelines for quality management systems, organization and personnel, and warehouse storage requirements, among others. Under the new GDP, for the first time distributors are also being required to document the names of their supplier, original manufacturer, and/ or shipping agent; the manufacturer’s batch number and certificate of analysis; purchase orders; and retest date or expiry date. The tighter controls are designed to keep falsified APIs from entering the supply chain, reducing the potential that counterfeit, substandard or incorrect ingredients will be sold to drug manufacturers.
TAPI begins extending the guidelines worldwide
From the day TAPI was founded more than 80 years ago, quality has been the foundation of everything we do, from development to distribution. Our rigorous standards ensure the quality and integrity of our products are maintained through the entire supply chain, and frequent inspections by regulatory authorities ensure we are in compliance.
Because TAPI follows its own strict internal standards and current Good Manufacturing Practices (cGMP), we were in compliance with most of the European Commission’s new guidelines before the latest directive took effect.The new guidelines primarily impact TAPI in two ways: we need to ensure service providers who transport our products are in compliance, and that our ambient products are transported in temperature-controlled conditions.
While the new guidelines apply only within the European Union, TAPI has begun implementing new procedures within our organization on a global scale. We regularly conduct global logistics forums to share best practices with all TAPI sites worldwide and are using e-learning to train employees in logistics, warehousing and distribution on all aspects of good distribution practice.
Temperature control is a hot topic
Distributors have long met requirements for handling cold chain products (2° to 8°C), but under the EU-GDP guidelines, API distributors must also ensure that ambient products are transported in temperature-controlled conditions as determined by the manufacturer. The EU requires them to document temperature-control methods for air, sea and road transport to customers in different locations in all seasons. One way TAPI reduces the risk of temperature deviations is the use of thermal blankets or other passive and active packaging solutions for air freight, reefer containers for sea freight, and temperature-controlled trucks for road freight.
Selecting the right service providers with good distribution practices for APIs is key for making sure your distribution network is compliant. At TAPI, we require our logistics service providers to meet the new GDP guidelines governing their operations to ensure they too are in compliance. We work very closely with our logistics partners to continuously track and document our shipments throughout our distribution network so the temperature requirements for our products are met. As part of TAPI’s culture, we strive for continuous improvement, so we are always evaluating the methods we use and looking for ways to make them even better.
The new EU-GDP guidelines have required procedural changes across the industry, and tighter controls and more transparency at each step will ensure API products are safer and high quality. At TAPI, we have developed industry-leading best practices and meet the latest regulatory requirements so our customers can be confident they are getting products they can trust.
Bertil Wagensveld is Global Logistics Director for TAPI, based in Amsterdam. He is an experienced supply chain professional with 15 years of experience in the Teva API Division. Prior to his current position, Bertil was responsible for logistics and order management within the commercial organization of Teva API.
To learn more about how TAPI is meeting the new EU-GDP guidelines, please contact us