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  2. Good manufacturing practice - Wikipedia

    en.wikipedia.org/wiki/Good_manufacturing_practice

    Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies.Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, [1] cosmetics, [2] pharmaceutical products, [3] dietary supplements, [4] and medical devices. [5]

  3. Title 21 of the Code of Federal Regulations - Wikipedia

    en.wikipedia.org/wiki/Title_21_of_the_Code_of...

    The 600 series covers biological products (e.g. vaccines, blood): 601 Licensing under section 351 of the Public Health Service Act; 606 et seq. cGMPs for human blood and blood products; The 700 series includes the limited regulations on cosmetics: 701 Labeling requirements; The 800 series are for medical devices: 803 Medical device reporting

  4. Center for Drug Evaluation and Research - Wikipedia

    en.wikipedia.org/wiki/Center_for_Drug_Evaluation...

    The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and Research.

  5. Biomanufacturing - Wikipedia

    en.wikipedia.org/wiki/Biomanufacturing

    Products manufactured for medical or food use must be produced in facilities designed and operated according to Good Manufacturing Practice (GMP) regulations. Cleanrooms are often required to control the levels of particulates and microorganisms. Sterilization and aseptic processing equipment are required for production of injectable products.

  6. Validation (drug manufacture) - Wikipedia

    en.wikipedia.org/wiki/Validation_(drug_manufacture)

    This is to maintain and assure a higher degree of quality of food and drug products. "Process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.

  7. EudraLex - Wikipedia

    en.wikipedia.org/wiki/EudraLex

    Vol. 1: Pharmaceutical legislation: medicinal products for human use. ISBN 92-828-2032-7; Vol. 2: Notice to applicants: medicinal products for human use. ISBN 0-11-975780-X; Vol. 3: Guidelines: medicinal products for human use. ISBN 92-828-2436-5; Vol. 4: Good manufacturing practices: medicinal products for human and veterinary use. ISBN 92-828 ...

  8. Good laboratory practice - Wikipedia

    en.wikipedia.org/wiki/Good_Laboratory_Practice

    These regulations set the standards for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products such as food additives, drugs, medical devices, or biological products. [17]

  9. Good documentation practice - Wikipedia

    en.wikipedia.org/wiki/Good_documentation_practice

    Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.