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  2. Validation (drug manufacture) - Wikipedia

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

    In the UK, computer validation is covered in Annex 11 of the EU GMP regulations (EMEA 2011). The FDA introduced 21 CFR Part 11 for rules on the use of electronic records, electronic signatures (FDA 1997). The FDA regulation is harmonized with ISO 8402:1994, [6] which treats "verification" and "validation" as separate and distinct terms.

  3. 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]

  4. List of European Union directives - Wikipedia

    en.wikipedia.org/wiki/List_of_European_Union...

    This list of European Union Directives is ordered by theme to follow EU law. For a date based list, see the Category:European Union directives by number . From 1 January 1992 to 31 December 2014, numbers assigned by the General Secretariat of the Council followed adoption, for instance: Directive 2010/75/EU. [ 1 ]

  5. EudraGMP - Wikipedia

    en.wikipedia.org/wiki/EudraGMP

    The database serves as a quick reference for checking the good manufacturing practice (GMP) of a potential contract manufacturer. One can search by the “company name, location, or certificate number and find details on the types of products or activities that the company conducts and the date of the most recent GMP inspection.” [ 3 ]

  6. 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]

  7. US manufacturing contraction slows in November, outlook uncertain

    www.aol.com/news/us-manufacturing-improves...

    WASHINGTON (Reuters) -U.S. manufacturing contracted at a moderate pace in November, with orders growing for the first time in eight months and factories facing significantly lower prices for inputs.

  8. Doctors Explain The Surprising Reason Birth Control Is Less ...

    www.aol.com/doctors-explain-surprising-reason...

    Ozempic and other GLP-1 agonist medications might interfere with birth control and give certain patients a fertility boost, say doctors.

  9. European Directorate for the Quality of Medicines & HealthCare

    en.wikipedia.org/wiki/European_Directorate_for...

    The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964: ETS 50, [2] Protocol [3]).