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  2. United States Pharmacopeia - Wikipedia

    en.wikipedia.org/wiki/United_States_Pharmacopeia

    Products that meet the requirements of the program can display the USP Verified Dietary Supplement Mark on their labels. [5] This is different from seeing the letters "USP" alone on a dietary supplement label, which means that the manufacturer is claiming to adhere to USP standards. USP does not test such products as it does with USP Verified ...

  3. Chemical purity - Wikipedia

    en.wikipedia.org/wiki/Chemical_purity

    USP grade is equivalent to the ACS grade for many drugs. NF grade is a purity grade set by the National Formulary (NF). NF grade is equivalent to the ACS grade for many drugs. British Pharmacopoeia: Meets or exceeds requirements set by the British Pharmacopoeia (BP). Can be used for food, drug, and medical purposes, and also for most laboratory ...

  4. IEC 62304 - Wikipedia

    en.wikipedia.org/wiki/IEC_62304

    The IEC 62304 standard calls out certain cautions on using software, particularly SOUP (software of unknown pedigree or provenance).The standard spells out a risk-based decision model on when the use of SOUP is acceptable, and defines testing requirements for SOUP to support a rationale on why such software should be used.

  5. USP 800 - Wikipedia

    en.wikipedia.org/wiki/USP_800

    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".

  6. Good manufacturing practice - Wikipedia

    en.wikipedia.org/wiki/Good_manufacturing_practice

    Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a manufactured product is safe for human consumption or use. Many countries have legislated that manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation.

  7. Clinical Laboratory Improvement Amendments - Wikipedia

    en.wikipedia.org/wiki/Clinical_Laboratory...

    Score 2 is assigned when the characteristics for a particular test are intermediate between the descriptions listed for scores of 1 and 3. [5] Criteria for categorization: Knowledge; Training and experience; Reagents and materials preparation; Characteristics of operational steps; Calibration, quality control, and proficiency testing materials

  8. Medical billing - Wikipedia

    en.wikipedia.org/wiki/Medical_billing

    Medical billing, a payment process in the United States healthcare system, is the process of reviewing a patient's medical records and using information about their diagnoses and procedures to determine which services are billable and to whom they are billed.

  9. Good laboratory practice - Wikipedia

    en.wikipedia.org/wiki/Good_Laboratory_Practice

    The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]

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