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  2. Operations manual - Wikipedia

    en.wikipedia.org/wiki/Operations_manual

    The operations manual is the documentation by which an organisation provides guidance for members and employees to perform their functions correctly and reasonably efficiently. [1] It documents the approved standard procedures for performing operations safely to produce goods and provide services. [ 2 ]

  3. 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 ]

  4. Computerized system validation - Wikipedia

    en.wikipedia.org/wiki/Computerized_system_validation

    Similarly, The Rules Governing Medicinal Products in the European Union, Volume 4, Annex 11: Computerised Systems applies to all forms of computerized systems used as part of a GMP regulated activities and defines Computer System Validation Elements [2]

  5. User guide - Wikipedia

    en.wikipedia.org/wiki/User_guide

    User manuals and user guides for most non-trivial PC and browser software applications are book-like documents with contents similar to the above list. They may be distributed either in print or electronically. Some documents have a more fluid structure with many internal links. The Google Earth User Guide [4] is an example of

  6. Good automated manufacturing practice - Wikipedia

    en.wikipedia.org/wiki/Good_Automated...

    ISPE has published a series of good practice guides for the industry on several topics involved in drug manufacturing. The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture.

  7. Microsoft Office XML formats - Wikipedia

    en.wikipedia.org/wiki/Microsoft_Office_XML_formats

    Besides differences in the schema, there are several other differences between the earlier Office XML schema formats and Office Open XML. Whereas the data in Office Open XML documents is stored in multiple parts and compressed in a ZIP file conforming to the Open Packaging Conventions, Microsoft Office XML formats are stored as plain single monolithic XML files (making them quite large ...

  8. 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.

  9. Validation (drug manufacture) - Wikipedia

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

    The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide ...

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