Good manufacturing practice (GMP) is the key part of the quality assurance for medicines in the European Economic Area (EEA). EU-GMP is to ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use in EEA. Volume 4 in Eudralex (EU Legislation) for "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively.
The EU-GMP Chapter App presents Part I (Chapter 1-9) and Part II of Volume 4 in Eudralex with user-friendly e-format. The users can easily reach to each part of the content. This is a convenient self-education and reference for all people working in pharmaceutical and biotech industries.
Keywords :EU-GMP, Good Manufacturing Practice, The European Medicines Agency, EMA, Eudralex, Regulation, Pharmaceutical, Biotechnology
The Internal Contamination Clinical Reference app is a reference tool to be used for educational and informational purposes only. The app provides information about internal contamination with a number of radionuclides and their medical countermeasure. The app estimates reference concentrations of radionuclides in urine using standard biokinetics models and assuming intakes equal to one Clinical Decision Guide (CDG) for each radionuclide based on hypothetical patient scenarios. The intended audience for the app is clinicians, health physicists, radiation safety officers, medical and public health laboratory scientists, or any other professional interested in internal contamination with radioactive materials and their medical therapy. Some basic understanding of concepts behind internal contamination and internal dosimetry are required to fully benefit from this application. The Internal Contamination Clinical Reference app features:
Reference information on a particular radionuclide or a medical countermeasure
Users can perform assessments based on hypothetical patient scenarios with each assessment projecting a reference concentration of radionuclides in urine based on user input
The assessment can be saved, edited and shared
For more information, please visit http://www.cdc.gov/nceh/radiation/ or email email@example.com.
This app was developed and produced by the Centers for Disease Control and Prevention http://www.cdc.gov and Oak Ridge Institute for Science and Education (ORISE) http://www.orau.gov/orise.htm through an interagency agreement with the U.S. Department of Energy (DOE). ORISE is managed by Oak Ridge Associated Universities under DOE contract number DE-AC05-06OR23100.