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Title II, the Drug Supply Chain Security Act (DSCSA), established requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain. These requirements included a ten-year timeline culminating in the building of "an electronic, interoperable system to identify and trace certain ...
Hazard analysis and critical control points is a methodology which has been proven useful. [21] Quality assurance extends beyond the packaging operations through distribution and cold chain management; Good distribution practice is often a regulatory requirement. Track and trace systems are usually required.
PAT is a term used for describing a broader change in pharmaceutical manufacturing from static batch manufacturing to a more dynamic approach. It involves defining the Critical Process Parameters (CPPs) of the equipment used to make the product, which affect the Critical Quality Attributes (CQAs) of the product and then controlling these CPPs ...
The Supply Chain Operations Reference (SCOR) model is a process reference model originally developed and endorsed by the Supply Chain Council, now a part of ASCM, as the cross-industry, standard diagnostic tool for supply chain management. [1]
Supply-chain management (SCM) has become increasingly relevant in theory and practice in light of more-complex supply chains. The SCM performs extensive operational tasks, including supply-chain controlling. Seuring [1] transfers the three main concepts of German supply chain-controlling literature into the specific demands of SCM:
The McKinsey 7S Framework is a management model developed by business consultants Robert H. Waterman, Jr. and Tom Peters (who also developed the MBWA-- "Management By Walking Around" motif, and authored In Search of Excellence) in the 1980s. This was a strategic vision for groups, to include businesses, business units, and teams. The 7 S's are ...
A supply chain is the network of all the individuals, organizations, resources, activities and technology involved in the creation and sale of a product. A supply chain encompasses everything from the delivery of source materials from the supplier to the manufacturer through to its eventual delivery to the end user.
Collaborative planning, forecasting, and replenishment (CPFR) is an approach to the supply chain process which focuses on joint practices.This is done through cooperative management of inventory through joint visibility and replenishment of products throughout the supply chain.