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- EDQM set to implement European Pharmacopoeia Version 6.8 in June 2010
European Directorate for the Quality of Medicines & HealthCare (EDQM) will
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EDQM set to implement European Pharmacopoeia Version 6.8 in June 2010
European Directorate for the Quality of Medicines & HealthCare (EDQM) will launch the European Pharmacopoeia Version 6.8 in a few weeks which will be implemented from June this year. Currently, the Pharmacopoeia published by the Council of Europe, will now be brought out by the EDQM. Among the new additions which include functionality-related characteristics of excipients also focuses on guidance to maximize the quality of organs, tissues and cells, besides record the success rate of transplants with the objective to minimize risks, according to Caroline Larsen Le Tarnec, head of the Public Relations & Documentation Division at EDQM. Tarnec was in India during the two-day IPA – EDQM – IPC Technical Conference 2010 organized by Indian Pharmaceutical Association (IPA) in collaboration with EDQM in Mumbai early this month which highlighted the latest on offer by EDQM Publications & Services. According to Kaushik Desai, member, executive council, Indian Pharmaceutical Association and CEO, Global Pharma Tech, there is a need to continuously update the quality standards. Therefore for EDQM this effort is a step in the right direction. The new version has also incorporated revisions in sections related to pesticide residues, microbiological examination of non-sterile products which covers microbial enumeration tests along with microbiological examination of non-sterile products that includes test for specified micro-organisms. There is also an update on chromatographic separation techniques, determination of ‘ochratoxin A’ in herbal drugs and microbiological quality of non-sterile pharmaceutical preparation and substances for pharmaceutical use, said Tarnec. There are also new indications of the status of pharmacopoeial harmonization between EP, USP and JP. This will cover electrophoresis, capillary electrophoresis isoelectric focus, peptide mapping, amino acid analysis, friability of uncoated tablets, specific surface area by gas adsorption, powder flow, optical microscopy and particle-size distribution estimation by analytical sieving. There are also separate guidelines on blood products and organ transplantation. The latter provides a guide to safety and quality assurance for the transplantation of organs, tissues and cells of human origin (allogenic and autologous) used for transplantation purposes. Further, the revised version has also incorporated approaches for quality assessment implementation of pharmaceutical care in practice and required competences and skills. In addition, technical guides for the elaboration of monographs on synthetic peptides and recombinant DNA proteins, structure & nomenclature of chemical formulae, herbal drug preparations besides fatty oils and derivatives, vaccines and other immunological human medicinal products are also provided. It has also given importance to check the authenticity of the the hologram on packs.
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