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Validation involves collecting documentary evidence of all aspects of compliance. [20] 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.
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".
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 ...
The BSI Group undertakes an annual survey of supply chain risk exposure, identifying and updating the main supply chain security concerns. In its 2020 report, drug smuggling , cargo theft of pharmaceuticals and medical supplies and increasing warehouse and facility theft were identified as particular concerns.
To overcome these challenges, companies mitigate supply chain interruptions and reduce risk with strategies and tactics that address supplier-centric risk at multiple stages in the relationship: On boarding: Bringing suppliers into the operation with registration that includes: A centralized supplier registration portal
Prednisone is a glucocorticoid medication mostly used to suppress the immune system and decrease inflammation in conditions such as asthma, COPD, and rheumatologic diseases. [3] It is also used to treat high blood calcium due to cancer and adrenal insufficiency along with other steroids . [ 3 ]
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.
Operating and managing a global supply chain comes with several risks. These risks can be divided into two main categories: supply-side risk and demand side risk. [4] Supply-side risk is a category that includes risks accompanied by the availability of raw materials which effects the ability of the company to satisfy customer demands. [4]