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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.
ISO 10241-1:2011 Part 1: General requirements and examples of presentation; ISO 10241-2:2012 Part 2: Adoption of standardized terminological entries; ISO 10243:2010 Tools for pressing – Compression springs with rectangular section – Housing dimensions and colour coding; ISO 10244:2010 Document management - Business process baselining and ...
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]
For example, several types of microneedle patches have been developed for administering vaccines and other medications to reduce the risk of needlestick injury. [ 4 ] [ 8 ] Drug delivery is a concept heavily integrated with dosage form and route of administration , the latter sometimes being considered part of the definition. [ 9 ]
This area of concern is widening to include such considerations as the effect on local communities, the health and welfare of employees and a more thorough examination of a company's supply chain. One of the major frameworks used is the United Nations Guiding Principles on Business and Human Rights .