Issue link: https://www.e-digitaleditions.com/i/1462155
44 Pharmaceutical Technology QUALITY AND REGULATORY SOURCEBOOK EBOOK MARCH 2022 P h a r mTe c h . c o m Regulations: Supply Chain uct data must be recognized as a vital asset, and ongoing data management a fundamental priority. Time is short The manufacturers did not reach 90% barcoding success overnight. It took top-down organiza- tional and industry commitment, involving a con- siderable investment of time and resources. Each year, each barcode assessment revealed glitches and errors that needed fixing so the barcodes would scan properly. Syntax and printing issues had to be worked out. Lessons learned informed the suppliers' practices for improvements, based on these evaluations. Establishing interoperability is even more com- plicated. Organizations generally manage data differently, often using proprietary systems that are not designed to communicate with external entities in an interoperable manner. Incompatible data formats or unintended business processes can prevent effective exchange. Deep collabora- tion is needed to ensure compatibility. It will take time, and a period of trial and error is part of the process. Manufacturers should al- ready be work ing with distributors, so these distributors can work with their downstream partners, on testing information exchange. The deadline is perilously near if we consider the re- maining outstanding tasks to be completed. Keeping patients safe When all pharmaceutical supply chain stakeholders are sharing trusted, standardized data in real time, full traceability will be enabled and the DSCSA mis- sion fulfilled, ultimately helping protect patients' "five rights" of medication use: assuring that the right patient can receive the right drug, at the right time, in the right dose, and via the right route. References 1. GS1 US, "Progress on 2023 DSCSA Interoperability," gs1us. org, accessed Feb. 16, 2022. 2. FDA, Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act Guidance for Industry, Draft Guidance (CDER, CBER, June 2021). PT In this episode Pharmacutical Technology's Drug Solutions Podcast, Chris Spivey, Editorial Director, talks about the eco- nomic and geopolitical benefits of controlling pharmaceu- tical manufacturing through reshoring with Dr. Fernando Muzzio, distinguished professor of chemical and biochemical engineering, Rutgers University, and Frederic Kahn, VP Sales, Wavelength Pharmaceuticals. Supply chain fragility and geopolitical instability is discussed as background to in-shoring pharmaceutical manufacturing by Dr. Fernando Muzzio, distinguished professor of chemical and biochemical engineering, Rutgers University and Frederic Kahn, VP Sales, Wavelength Pharmaceuticals. This discussion covers reforming regulations and economic s, while introducing novel flow chemistries, robotics, digitalization, and a heightened agility for investment in education, national strategy, and communications. Click here to listen to this podcast. About Drug Solutions Pharmaceutical Technology presents the Drug Solutions pod- cast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest ques- tions—from the technologies, to strategies, to regulations re- lated to the development and manufacture of drug products. —The Editors of Pharmaceutical Technology Drug Solutions Podcast: Securing Manufacturing Independence Through Re-shoring Facilities to USA Lessons learned informed the suppliers' practices for improvements, based on these evaluations.