ILC Dover Completes Rx-360 Packaging and Supply Chain Security Audit with no critical Observations
ILC-Dover completes a Rx-360 audit- a rigorous review of pharmaceutical supply chain security and materials.
ILC Dover successfully completed the Rx-360 Pharmaceutical Industry consortium audits for packaging and supply chain security. Rx-360’s mission “to protect patient safety by sharing information and developing processes to improve the integrity of the health care supply chain and the quality of materials within the supply chain” complements ILC Dover’s continuing commitment to quality, continual improvement and existing certifications such as ISO 9001.
As the industry leader in single-use powder containment, we provide process solutions to reduce powder dispensing times, stop contamination, and minimize waste. We make filling and sealing easy using with our rugged Amorflex ® anti-static single use containers. We have qualified solutions from media and buffer preparation to API manufacturing and oral solid dosage processing.
The recent assessment is conducted on a voluntary basis and encompasses a wide assortment of practices ranging from supply chain security, quality management, training, manufacturing practices and site and technological security and more. The audit spanned two days to complete a comprehensive sampling of the entire Pharmaceutical operation. At the conclusion of the audit no critical observations were noted. A unique feature of the Rx-360 audit process includes the ability of our customer base to access the actual audit report via Rx-360, enhancing transparency with our customers and potentially decreasing costs by eliminating or reducing the need for, or frequency of, site audits.
Starting in 2009, the Rx-360 consortium - currently with approximately 60 members -works to enhance supply chain security with a focus on assuring the quality and authenticity of pharmaceutical products. There is a need to establish best practices for supply chain security and a mission to share them. The audits encompass the entire supply chain from the origin of incoming materials to shipping of final products.
About ILC Dover
ILC Dover is a world leader in the innovative design and production of engineered products employing high-performance flexible materials. Since 1947, ILC has provided engineered solutions to complex customer problems. Known for its production of space suits for NASA, the company leverages its vast materials, engineering, process, and design experience to create high performance systems for a wide range of industries, including pharmaceutical and biopharmaceutical manufacturing, infrastructure flood protection, inflatable airships, and aeronautical and deep space systems. ILC Dover’s pharmaceutical division specializes in protecting workers and the medicines they are making using flexible single use containers to minimize contamination concerns.
ILC Dover – creating what’s next
Rx-360 was formed in 2009 to support an industry-wide commitment to ensuring patient safety by enhancing quality and authenticity throughout the supply chain. The mission of the organization was timely in light of growing attacks and threats to an increasingly complex and global supply chain. Millions of people around the world are treated every day with the vital medicines that pharmaceutical and biotechnology companies provide. Management of the pharmaceutical supply chain has become one of the top public health concerns with respect to consumer safety. The globalization of distribution for both drug components and finished products has introduced many complications that Rx-360 is positioned to help resolve. To learn more about Rx-360 or its joint audit program, go to the Rx-360 website at www.Rx-360.org