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EDQM Hosted Events International Meeting of World Pharmacopeias

In early October EDQM hosted the 4th WHO International Meeting of World Pharmacopoeias at its Strasbourg France headquarters. The meeting focused on harmonization and strengthening WHO’s role in developing global standards for the production and testing of medicines. That same week EDQM hosted its 50th anniversary meeting that included workshops on QbD, impurities, certification, and […]

EDQM CEP Form Updates

The application forms for requesting certificates of suitability (CEPs) were updated in late September to reflect recent changes to the EDQM guideline on the requirements for revision/renewal of CEPs to the European Pharmacopeia Monograph, issued in July 2014, as well as invoicing changes. These forms are meant to be used for applications submitted from October […]

USP Joins Alliance for Safe Online Pharmacies

USP announced in a mid-August press release that it had joined the Alliance for Safe Online Pharmacies “to combat the threat posed by the illegal online sale of medicines.” The USP release notes that “nearly 97%” of online pharmacies that do not comply with applicable drug laws and standards.

IPQ Monthly Update, July 2014

IPQ’s coverage during July focused heavily on the efforts worldwide to address the threats that loom along the global supply chain to the quality of the products that patients receive. Included in the July Monthly Update are stories addressing: ● APEC’s broad-based, multi-faceted initiatives ● pharmacopeial modernization and harmonization efforts, and ● FDA’s track and trace implementation. Also in this issue are valuable insights from FDA’s microbiology review staff on: ● top micro deficiencies in applications, and ● upgrading micro methods and processes....

Ph. Eur. Requests Comments on Inhaled Drug QC Methodologies

The Inhalanda Working Party of the European Pharmacopoeia issued an inquiry in August, seeking comments and/or data on Abbreviated Impactor Measurement(AIM) and Efficient Data Analysis (EDA) methodologies for the quality control of inhaled drugs. The working party is looking for information that shows whether AIM and/or EDA can be effectively used in the quality control […]

USP Official Chapter <787> and <1787> for Particulate Matter

USP issued a new official general chapter <787> in early August on particulate matter for sensitive protein formulations. Chapter <787> includes a testing framework for issues regarding the immunological effects of sub-10µm particles. Informational chapter <1787> accompanies the general chapter to provide guidance on sub-visible particles in the 2 to 100µm range and will become official […]

Pharmacopeial Modernization and Harmonization Efforts Spurred by Global Supply Chain Regulatory Needs; China’s Pharmacopeia Among Asian Participants

The risks to product quality in an increasingly globalized supply chain – a prime driver of the CMC and GMP agendas of regulatory agencies – are also pushing pharmacopeias around the world to speed up their efforts to harmonize and modernize the compendial standards that support these regulatory processes....

Annual Meeting of the National Pharmacopoeia Authorities (NPA) of the Ph. Eur.

In late May, the annual meeting of the National Pharmacopeia Authorities (NPA) of the European Pharmacopoeia took place in London. According to the EDQM press release, following the event, the main topics discussed were: ● the implementation strategy for the future ICH Q3D guideline on elemental impurities ● current quality topics that have a potential […]

USP Proposes New Standards for Organic Impurities

Appearing in the May-June 2014 issue of the Pharmacopoeial Forum (PF) were a draft chapter proposal and a draft chapter revision updating USP’s coverage of organic impurities. The revision of general chapter <1086> on drug substance/product impurities and the proposal for the addition of a chapter <476> on drug substance/product organic impurities, which will align […]

In mid-May, EDQM published a draft of its first finished product monograph, covering sitagliptin phosphate tablets, for comment. The monograph is available in the online forum Pharmeuropa. EDQM notes that “finished product monographs will be elaborated according to the same general principles as for other monographs in the Ph. Eur. to ensure the same high […]
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