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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.
Included here are companies engaged not only in pharmaceutical development, but also supply chain management and device development, including compounding pharmacies. Firms with no marketed products but which are working on pharmaceutical development as well as mature firms with a post-marketed portfolios have been included here.
The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products. [1] [2] The initial members comprised the 10 member countries of EFTA at that time.
The following is a list of countries by pharmaceutical exports.. Global sales from exported drugs and medicines by country total US$371.3 billion in 2018. Overall the value of drugs and medicine exports grew by an average 5.80% for all exporting countries since 2014 when drugs and medicines shipments were valued at $344.1 billion.
Drug packaging (or pharmaceutical packaging) is process of packing pharmaceutical preparations for distribution, and the physical packaging in which they are stored. It involves all of the operations from production through drug distribution channels to the end consumer.
The Site Master file contains specific and factual GMP information about the production and control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, the site master file needs to ...
More specifically, the ISPE's guide The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested ...