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The content and the format for drug master file used in United States differs from that used in European Countries to obtain market authorization (MA). The Main Objective of the EDMF is to support regulatory requirements of a medicinal product to prove its quality, safety and efficacy. This helps to obtain a Marketing Authorisation grant.
The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).
The American Medical Association (AMA) Physician Professional Data (formerly known as the AMA Physician Masterfile) includes current and historical data on all physicians, including AMA members and nonmembers, and graduates of foreign medical schools who reside in the United States and who have met the educational and credentialing requirements necessary for recognition as physicians. [1]
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.
Obtaining a certificate is voluntary in some fields, but in others, certification from a government-accredited agency may be legally required to perform certain jobs or tasks. Organizations in the United States involved in setting standards for certification include the American National Standards Institute (ANSI) and the Institute for ...
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A kardex (plural kardexes) is a genericised trademark for a medication administration record. [2] The term is common in Ireland and the United Kingdom.In the Philippines, the term is used to refer the old census charts of the charge nurse usually used during endorsement, in which index cards are used, but has been gradually been replaced by modern health data systems and pre-printed charts and ...
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