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The US Drug Supply and Chain Security Act (DSCSA), was enacted by Congress on November 26, 2013 and outlines requirements to build electronic systems that identify and trace prescription drugs distributed in the US. [8] By November 27th 2023, full electronic track & trace capability will be required for all partners in the supply chain. [9]
The pharmaceutical industry is a medical industry that discovers, develops, produces, and markets pharmaceutical goods such as medications and medical devices. Medications are then administered to (or self-administered by) patients for curing or preventing disease or to alleviate symptoms of illness or injury.
Example pharmaceutical packaging line. All aspects of pharmaceutical production, including packaging, are tightly controlled and have regulatory requirements. Uniformity, cleanliness , sterility, and other requirements are needed to maintain Good Manufacturing Practices. Product safety management is vital.
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.
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
Supply-chain risk management is aimed at managing risks in complex and dynamic supply and demand networks. [1] (cf. Wieland/Wallenburg, 2011)Supply chain risk management (SCRM) is "the implementation of strategies to manage both everyday and exceptional risks along the supply chain based on continuous risk assessment with the objective of reducing vulnerability and ensuring continuity".
A cold chain is a supply chain that uses refrigeration to maintain perishable goods, such as pharmaceuticals, produce or other goods that are temperature-sensitive. [1] Common goods, sometimes called cool cargo, [2] distributed in cold chains include fresh agricultural produce, [3] seafood, frozen food, photographic film, chemicals, and pharmaceutical products. [4]
Typically, supply-chain managers aim to maximize the profitable operation of their manufacturing and distribution supply chain. This could include measures like maximizing gross margin return on inventory invested (balancing the cost of inventory at all points in the supply chain with availability to the customer), minimizing total operating expenses (transportation, inventory and ...