During the recently held 56th meeting of the WHO expert committee on Biological Standardisation, the European Directory for Quality of Medicines (EDQM) was designated as a WHO collaborative centre for the establishment and distribution of International Standards for Antibiotics (ISA), sources at EDQM informed Pharmabiz.

The EDQM has taken over the responsibility for the establishment, storage and distribution of WHO ISA from the National Institute for Biological Standards and Control (NIBSC), with effect from May 4, 2006.

EDQM continues to distribute batches previously established and distributed by NIBSC using their previous identification code but adding the prefix 'ISA'. From now, EDQM will conduct international collaborative studies to replace batches or to introduce new international standards for which an ISA is needed, the sources informed.

These standards are essential in the standardisation and quality control of antibiotic material and pharmaceutical products. They are supplied for assays described in the specifications for quality control of antibiotic material.

ISAs are primary standards intended to establish national / regional secondary standards. ISAs should not be used as working standards in routine assays as they are produced in a limited quantity. Existing well-established secondary standards, which fulfill requirements such as regional, national or in house standards, should be used as working standards.