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Susan Haigney is managing editor of BioPharm International, email@example.com.
The directorate highlights achievements accomplished during the year of its 50th anniversary.
On June 1, 2015, the European Directorate for the Quality of Medicines & Healthcare (EDQM) announced the publication of its annual report for 2014, which was also the agency’s 50th anniversary. Director Susanne Keitel detailed the directorate’s achievements during the past 50 years in the report’s forward. She also thanked the EDQM’s member states, saying “none of the EDQM’s achievements would have been possible without the unwavering support of its member states and all those who have helped build the EDQM and taken part in its activities.”
An update on EDQM’s status with the International Organization on Standardization (ISO) shows that EDQM has maintained ISO 9001:2008 certification for the evaluation of applications for monograph suitability in the European Pharmacopoeia (Ph. Eur.); management of site inspection programs; postmarketing surveillance studies for drug products and databases; coordination of Official Control Authority Batch Release procedures for biologicals; management and distribution of the writing and revision of Ph. Eur. texts; and performing laboratory studies. The EDQM laboratory underwent an ISO 17025:2005 audit by BELAC, the Belgian accreditation body. The audit maintained the lab’s certification as technically competent and “able to generate technically valid results.”
The report highlighted feedback from workshops performed during a three-day conference held in Strasbourg in October 2014 in honor of the 50th anniversary. The following are some of the highlights:
Monographs, general chapters, and reference standards added in 2014
The EDQM Annual Report mentions the adoption of 26 new monographs including two on patent-protected active substances: imatinib mesilate (2736) and rosuvastatin calcium (2631). Two new general chapters cover the topics of methyl, ethyl, and isospropyl toluenesulfonate in active substances (2.5.40) and monographs on herbal drug extracts (5.23). Additionally, 191 texts were revised, including Reference Standards (5.12) and the monograph on herbal drug extracts (0765).
The Ph. Eur. Commission adopted 76 batches of new reference standards and 172 replacement batches. Of the 55 assay reference standards established, 27 required collaborative study.
Manufacturers applied for 347 new Certifications of Suitability in 2014, up from 338 in 2013, and 1632 applied for revisions, up 15% from 2013. EDQM issued 355 new certificates and 1374 revised certificates in 2014.
Ph. Eur. Commission work programs initiated in 2014 included the following:
The Ph. Eur. Commission considered the following industry developments important in 2014:
The report goes on to detail EDQM event activities, results from a variety of working groups, training courses, and collaborative efforts by the Commission on a number of topics and initiatives from 2014. The full report can be downloaded from EDQM’s website.