Quality Technical Agreement Eudralex

Certification by qualified person and release of batches (in service since 15 April 2016) Detailed Commission directive of 8 December 2017 on good manufacturing practices for test drugs covered by Article 63, paragraph 1, paragraph 2, regulation (EU) 536/2014 (applicable from the date of the regulation (EU) no. 536/2014. 536/2014 on clinical trials) Volume 4 of the section ”The rules for medicines in the European Union” contains guidelines for interpreting the principles and guidelines for good manufacturing practices for human and veterinary use, in accordance with the Commission`s directives 91/356/CEE, as amended by Directive 2003/94/EC; 91/412/CEE. New – Parametric release (Commissioning Deadline: December 26, 2018) For more information about the consultation, click here. the use of ionizing radiation in the manufacture of medicines Qualification and validation (in service since 1 October 2015) Production of dose-dose-dose-pressure aerosol preparations for inhalation European Commission, companies and industry; ec.europa.eu/enterprise/ new – Manufacturing of biological active substances and medicines for human use (in service since June 26, 2018). Manufacturing of products based on human blood or human plasma (May 2011) www.gmp-compliance.org/files/guidemgr/vol4-chap7_2012-06_en.pdf The following directive can be ordered from the address listed in the ”Source/Publisher” category. In cases where you can order on the Internet, we have set up a hyperlink. The manufacture of veterinary medicines, with the exception of immunotherapy drugs, is no longer applicable to innovative therapy drugs for which the Commission`s Directive on Good Manufacturing Practices of Innovative Therapy Medicines, published in Part IV of Eudralex Volume 4, which will be operational from 22 May 2018, applies.