enow.com Web Search

Search results

  1. Results from the WOW.Com Content Network
  2. 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. The second edition (GAMP5) was released in July 2022. [2]

  3. 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.

  4. File:Gitmo-sop.pdf - Wikipedia

    en.wikipedia.org/wiki/File:Gitmo-sop.pdf

    Short title: Microsoft Word - Camp Delta 1-3 28 Mar 03a.doc: Image title: Camp Delta SOP: Author: JDOG Ops, 132nd MP Co, 240th MP Co, 303rd MP Co, 344th MP Co, 438th MP Co, 984th MP Co, 785th MP Bn, 2/116 IN Bn, MWD Det and others to numerous to list

  5. GxP - Wikipedia

    en.wikipedia.org/wiki/GxP

    A "c" or "C" is sometimes added to the front of the initialism. The preceding "c" stands for "current." For example, cGMP is an abbreviation for "current good manufacturing practice". The term GxP is frequently used to refer in a general way to a collection of quality guidelines. [1]

  6. Validation master plan - Wikipedia

    en.wikipedia.org/wiki/Validation_master_plan

    The GAMP 5 standard recommends an approach to the creation of the plan. [3]Topics commonly covered include: Introduction, scope, responsibilities, description of facility and design, building and plant Layout, cleanrooms and associated controlled environments, storage areas, personnel, personnel and material Flow, water and solid waste handling, infrastructure and utilities, water system ...

  7. Good engineering practice - Wikipedia

    en.wikipedia.org/wiki/Good_Engineering_Practice

    Good manufacturing practice (GMP) Best practice; American National Standards Institute (ANSI) Institute of Electrical and Electronics Engineers (IEEE) European Medicines Agency (EMEA) Food and Drug Administration (FDA) Ministry of Health, Labour and Welfare (Japan) Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation ...

  8. Pharmaceuticals and Medical Devices Agency - Wikipedia

    en.wikipedia.org/wiki/Pharmaceuticals_and...

    Auditing of manufacturers to ensure they conform to Good Manufacturing Practice (GMP) and have a suitable Quality Management System (QMS) Post-marketing drug safety: The collection, analysis and distribution of data on the quality, efficacy, and safety data of medicines and medical devices; Advising consumers on approved products

  9. 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]