EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use

  title={EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use},
  author={I. Inactive Ingredients},
  journal={Handbook of Pharmaceutical Manufacturing Formulations, Second Edition},
  • I. Ingredients
  • Published 7 January 2021
  • Business
  • Handbook of Pharmaceutical Manufacturing Formulations, Second Edition
This guidance applies to capping operations performed as an aseptic process using sterilized caps or as a “clean process” that is performed outside the aseptic core using clean non-sterilized caps. It is important to note that there may be other additional regional/local area requirements or expectations for capping operations that supersedes the information specified within EU GMP Annex 1 that must be considered (e.g. Irish Medicines Board (IMB) or the Medicines and Healthcare Products… 

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Implementation of a quality assurance system according to GMP and ISO 9001:2008 standard for radiopharmaceutical production in a public research centre

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  • 2012
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The applicability of a so-called component approach and a scaling concept to calculate extractables data for sterile polyethersulfone membrane filters and filter capsules of different sizes is shown.

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  • W. Grimm
  • Environmental Science
    Drug development and industrial pharmacy
  • 1998
The adjustments that are necessary to extend the stability testing requirements for a registration application within the three areas of the European Union, Japan, and the United States to countries of climatic zones III and IV are described.