A number of workshops (two in 2006 hosted by EDQM
and ICCVAM/ECVAM (reported by NIH, 2008) and one hosted by ZEBET in 2009 (Adler et al., 2010) attempted to bring the manufacturers together to progress the alternatives, but it is not clear how influential they were.
Detecting NDMA would have required gas chromatography coupled with mass spectrometry, a very sensitive level of testing, an EDQM
, The European Pharmacopea, EDQM
, Strasbourg, France, 8th edition, 2014.
25 percent of the manufacturing sites registered with EDQM
are from India.
In the absence of specific requirements at the European level, the Directorate for the Quality of Medicines & HealthCare of the Council of Europe (EDQM
) published a practical guide for manufacturers and regulators on metals and alloys used in food contact materials.
Where a raw material is the subject of a monograph of the European Pharmacopeia, it is, again, the applicant's responsibility to obtain a certificate of suitability that, where granted by the European Directorate for the Quality of Medicines (EDQM
), replaces the relevant data required in Directive 2001/83/EC.(14) Likewise, noteworthy is that, within the terms of Article 15 of the ATMP Regulation, it is the responsibility of "the holder of a marketing authorisation for an [ATMP]" to ensure that the individual product and its starting and raw materials can be traced from their sourcing.
WHO International Chemical Reference Substance (ICRS) for all samples analysed was obtained from the European Directorate for the Quality of Medicines and HealthCare (EDQM
), Strasbourg, France.
International institutions such as Interpol, the World Customs Organization (WCO) and The European Directorate for the Quality of Medicines (EDQM
) are working closely with governments and companies to create a global security system and strengthen regulations.
The company has filed four DMFs (Drug Master Files) for the pharmaceutical grade HA, passed the on-site inspection by US FDA, and obtained CEP certification from EDQM
(European Directorate for the Quality of Medicine & HealthCare).
, EUROPEAN PHARMACOPOEIA 7 0, metronidazole benzoate, 01/2008:0934.
Strasbourg, France: European Directorate for the Quality of Medicines & HealthCare (EDQM
) of the Council of Europe.
.eu/medias/fichiers/ The_Collection_Testing_and_Use_of_Blood_and_Blood_1.pdf, accessed on May 19, 2011.