• ICH Releases New Interchangeability Standard for Pharmaceutical Powders

    The International Conference on Harmonisation (ICH) has announced the release of a new quality document pertaining to the bulk density and tapped density of powders, saying two existing pharmacopoeial texts may be interchangeable within the ICH regions. The ICH is composed of three regions: the US, the EU and Japan. Two of the region's pharmacopoeias-the EU Pharmacopoeia and the US Pharmacopoeia-both have guidance documents available pertaining to the bulk density and ta...
  • USP Releases Overhaul of Impurities Testing Standards

    • 24 May 2012
    The US Pharmacopeia (USP), a standards-setting body for the content of medicines, has released two new standards to limit the presence of elemental impurities in medicinal products. The standards, <232> Elemental Impurities - Limits and <233> Elemental Impurities - Procedures , outline procedures on how to detect common impurities and sets limits on the presence of impurities to protect consumers from exposure. "Elemental impurities can occur naturally, b...
  • USP Plans to Launch Updated Heparin Standard to Ensure Safety

    • 23 May 2012
    The US Pharmacopoeia (USP) is announcing the impending launch of an updated standard meant to further boost the safety and quality of Herparin, contaminated supplies of which were associated with numerous deaths in 2007 and 2008.  "The third and latest round of revisions to USP's heparin standards will bring even greater sensitivity and precision to the tests and reference materials used to help ensure heparin quality," said USP in a statement. "In response to reque...
  • US, British Pharmacopoeias Tout Effort to Harmonize Drug Standards

    • 15 May 2012
    The US Pharmacopoeia (USP) and the British Pharmacopoeia (BP) have announced the harmonization of two drug product quality standards for two eye drop medications-a first for the two groups and an effort that could lead to more cooperation between the two groups in the future. The newly-harmonized standards cover dorzolamide hydrochloride ophthalmic solution and dorzolamide hydrochloride-timolol maleate ophthalmic solution, and are included in the Pharmacopeial Forum 38(...
  • USP Releases Proposed Standard on Supply Chain Integrity and Counterfeits

    The US Pharmacopeia (USP) released new proposed standards last week that are aimed at securing global supply chains and preventing counterfeit medicines from propagating. The standards-composed of a series of best practices-would ensure that: products are traceable to their original manufacturers; product integrity is ensured in both substance and identity; and product quality is maintained from manufacturer to consumer Further, the best practices would ensure th...
  • USP Releases Draft Standards for Probiotics and Microbial Food Cultures

    • 04 January 2012
    The US Pharmacopoeia (USP) on Tuesday released new draft standards to "help ensure the quality of probiotic food ingredients". The standards, released 2 January, are set to be incorporated in to the Food Chemicals Codex (FCC). The new standards- Microbial Food Cultures Including Probiotics- are contained within a new FCC Appendix and detail the essential quality specifications, intended uses in food, safety considerations, regulatory status, and purity of probiotics. ...