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USP establishes documentary (written) and reference (physical) standards for medicines, food ingredients, dietary supplement products, and ingredients. These standards are used by regulatory agencies and manufacturers to help to ensure that these products are of the appropriate identity, as well as strength, quality, purity, and consistency.
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Visual inspection is a common method of quality control, data acquisition, and data analysis.Visual Inspection, used in maintenance of facilities, mean inspection of equipment and structures using either or all of raw human senses such as vision, hearing, touch and smell and/or any non-specialized inspection equipment.
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Remote Visual Inspection or Remote Digital Video Inspection, also known as RVI or RDVI, is a form of visual inspection which uses visual aids including video technology to allow an inspector to look at objects and materials from a distance because the objects are inaccessible or are in dangerous environments. [1]
Cover of the European Pharmacopoeia, 11th Edition. The European Pharmacopoeia [1] (Pharmacopoeia Europaea, Ph. Eur.) is a major regional pharmacopoeia which provides common quality standards throughout the pharmaceutical industry in Europe to control the quality of medicines, and the substances used to manufacture them. [1]
USP 800 (Hazardous Drugs—Handling in Healthcare Settings) is a guideline created by the United States Pharmacopeia Convention (USP), as one of their General Chapters through which the USP "sets quality standards for medicines, dietary supplements and food ingredients".
The header identifies the FDA district office that performed the inspection, the date(s) of inspection, name and address of the facility that was inspected, the name and title of the individual to whom the 483 is issued to (usually the most responsible individual physically present in the facility), a brief description of the type of facility, and the facility's FEI (FDA Establishment ...