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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]
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 ...
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.
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.
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.
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]
Pharmaceutical publication planning involves developing a detailed plan that outlines the timely presentation of verified scientific and clinical data to appropriate types of healthcare professionals such as physicians, pharmacists, nurses, as a drug undergoes clinical trials and after it is marketed.
Pharmaceutical tablet presses are required to be easy to clean and quick to reconfigure with different tooling, because they are usually used to manufacture many different products. There are two main standards of tablet tooling used in pharmaceutical industry: American standard TSM and European standard EU.