EDQM Forms Working Group for General Methods Strategy

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 03-08-2015 18:42


The European Directorate for the Quality of Medicines and HealthCare (EDQM), which is responsible for the European Pharmacopoeia and the European biological standardization program, reports that European Pharmacopoeia Commission has appointed the chair and members of a specific Working Party (WP) to elaborate a new strategy for general methods.

"In order to stay state-of-the-art, it is crucial for the Ph. Eur. [European Pharmacopoeia] to closely follow new trends and technologies and to reflect them in its texts, where appropriate," said EDQM in a statement. "In this context, general methods are of specific relevance as they provide the ground-rules applicable to specific monographs and the need to have a thorough review of the adequacy of the existing texts has been identified as a priority by the Ph. Eur. [European Pharmacopoeia] Commission." The newly established WP will be in charge of defining the content and degree of detail to be provided. The outcome will be reflected in a guide for the elaboration of general methods to serve as a reference for the revision of general methods and the elaboration of future new ones.

The principles for elaborating the general chapters and monographs of the European Pharmacopoeia are continually adapted to keep pace with the regulatory needs of licensing, control, and inspection authorities in the public health area, and with technological and scientific advances and with industrial constraints. The European Pharmacopoeia Commission allocates the work to specially constituted groups of experts and working parties. The member of these groups come from regulatory authorities, official medicines control laboratories, pharmaceutical and chemical manufacturers, universities and research institutions.

Source: EDQM


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