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USP Controlled Room Temperature
The USP Controlled Room Temperature is a series of United States Pharmacopeia guidelines for the storage of pharmaceuticals; the relevant omnibus standard is USP 797. Although 100% compliance remains challenging for any given facility, the larger protocol may be regarded as constituting a form of clean room which is included in a suite of best practice A best practice is a method or technique that has been generally accepted as superior to alternatives because it tends to produce superior results. Best practices are used to achieve quality as an alternative to mandatory standards. Best practice ...s. References Drug safety {{pharmacy-stub ...
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Temperature
Temperature is a physical quantity that quantitatively expresses the attribute of hotness or coldness. Temperature is measurement, measured with a thermometer. It reflects the average kinetic energy of the vibrating and colliding atoms making up a substance. Thermometers are calibrated in various temperature scales that historically have relied on various reference points and thermometric substances for definition. The most common scales are the Celsius scale with the unit symbol °C (formerly called ''centigrade''), the Fahrenheit scale (°F), and the Kelvin scale (K), with the third being used predominantly for scientific purposes. The kelvin is one of the seven base units in the International System of Units (SI). Absolute zero, i.e., zero kelvin or −273.15 °C, is the lowest point in the thermodynamic temperature scale. Experimentally, it can be approached very closely but not actually reached, as recognized in the third law of thermodynamics. It would be impossible ...
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United States Pharmacopeia
The ''United States Pharmacopeia'' (''USP'') is a pharmacopeia (compendium of drug information) for the United States published annually by the over 200-year old United States Pharmacopeial Convention (usually also called the USP), a nonprofit organization that owns the trademark and also owns the copyright on the pharmacopeia itself. The ''USP'' is published in a combined volume with the ''National Formulary'' (a formulary) as the USP-NF. If a drug ingredient or drug product has an applicable ''USP'' quality standard (in the form of a ''USP-NF'' monograph), it must conform in order to use the designation "USP" or "NF". Drugs subject to ''USP'' standards include both human drugs ( prescription, over-the-counter, or otherwise) and animal drugs. ''USP-NF'' standards also have a role in US federal law; a drug or drug ingredient with a name recognized in ''USP-NF'' is considered adulterated if it does not satisfy compendial standards for strength, quality, or purity. USP also ...
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Clean Room
A cleanroom or clean room is an engineered space that maintains a very low concentration of airborne particulates. It is well-isolated, well-controlled from contamination, and actively cleansed. Such rooms are commonly needed for scientific research and in industrial production for all nanoscale processes, such as semiconductor device fabrication, semiconductor device manufacturing. A cleanroom is designed to keep everything from dust to airborne organisms or vaporised particles away from it, and so from whatever material is being handled inside it. A cleanroom can also prevent the escape of materials. This is often the primary aim in hazardous biological engineering, biology, nuclear engineering, nuclear work, pharmaceutical industry, pharmaceutics, and virology. Cleanrooms typically come with a cleanliness level quantified by the number of particles per cubic meter at a predetermined molecule measure. The ambient outdoor air in a typical urban area contains 35,000,000 pa ...
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Best Practice
A best practice is a method or technique that has been generally accepted as superior to alternatives because it tends to produce superior results. Best practices are used to achieve quality as an alternative to mandatory standards. Best practices can be based on self-assessment or benchmarking. Best practice is a feature of accredited management standards such as ISO 9000 and ISO 14001. Some consulting firms specialize in the area of best practice and offer ready-made templates to standardize business process documentation. Sometimes a best practice is not applicable or is inappropriate for a particular organization's needs. A key strategic talent required when applying best practice to organizations is the ability to balance the unique qualities of an organization with the practices that it has in common with others. Good operating practice is a strategic management term. More specific uses of the term include good agricultural practices, good manufacturing practice, good labora ...
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