‘Informal’ Process May Speed Harmonized Quality Standards, U.S., UK Pharmacopeias Say
The U.S. Pharmacopeial Convention (USP) and the British Pharmacopoeia (BP) have developed two drug-product quality standards under a new, flexible approach that signals a drive toward speedier harmonization — and a potential break for drugmakers.
The standards developed under the new “informal” harmonization effort took only one year to reach draft status and resulted in the first drug products to be unified in advance of inclusion in their respective compendia, the pharmacopeias said May 15.
The draft standards relate to analytical procedures for eye drop medications dorzolamide hydrochloride ophthalmic solution and dorzolamide hydrochloride-timolol maleate ophthalmic solution.
Doing business in the EU, UK, Canada or Australia? Whether your concern is pharmaceutical R&D, clinical studies, manufacturing or marketing — when it comes to pharma compliance, there’s only one authority.
Produced by the British Pharmacopoeia Commission Secretariat, the British Pharmacopoeia 2012 is the leading collection of standards for UK medicinal products and pharmaceutical substances.
Available in print and CD-ROM this is a must-have source for an international business. Order your copy today!