EDQM Releases 2014 Annual Report

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 50^th 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.”

2014 workshops

The report highlighted feedback from workshops performed during a three-day conference held in Strasbourg in October 2014 in honor of the 50^th anniversary. The following are some of the highlights:

• Feedback from the “Experiences with European Pharmacopoeia Monographs and Expectations for the Future” workshop was positive, according to the report, with recommendations including, “early availability of reference standards, provision of guidance on the cross validation of alternative methods, and the frequency of revisions to cover impurity profiles and new scientific and regulatory developments.”

• A workshop on quality by design (QbD) revealed that participants felt that more experience in the application of QbD was necessary and analytical methods and manufacturing processes should be examined.

• Participants of the “Finished Product Monographs” workshop identified the dissolution test as crucial. They also requested more harmonization of monographs among different pharmacopeias.

• New guidelines regarding impurities were discussed during the “Impurities” workshop. Collaboration between the Ph. Eur. and the industry was considered crucial for the workshop participants. Support for the International Conference on Harmonization (ICH) Q3D guideline on impurities was also expressed.

• Combatting counterfeit and illegal drugs was the topic of the “Combatting Illegal Medicines” workshop. Participants recommended the development of strategies to raise awareness regarding counterfeit drugs, providing new monographs, and developing new approaches to the problem, including a link to pharmacovigilance signals.

• The “Biologicals” workshop attendees expressed the need for flexibility and harmonization. “The application of the P4 procedure was considered to be a two-phase process; as a starting point, an evaluation of users’ needs and the elaboration of monographs on innovator products were considered necessary, followed, as more biosimilars emerged, by further evolution and standardization of thinking,” according to the report.

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.

Work programs

Ph. Eur. Commission work programs initiated in 2014 included the following:

• a pilot phase for writing a product-specific monoclonal antibody monograph using a multisource approach in order to test such an approach

• approval of general principals for monographs on finished products containing chemically defined active substances

• addition of a general monograph on coprocessed excipients

• the appointment of members to the Live Biotherapeutic Products Working party

• collaboration on the “PaedForm” project to improve access to suitable and age-appropriate drugs for children.

Industry developments

The Ph. Eur. Commission considered the following industry developments important in 2014:

• implementation of ICH Q3D, Guideline for Elemental Impurities

• the approval of the Ph. Eur. bacterial endotoxins policy

• revision of guidance on second identification tests.

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.

Source: EDQM