Pharmaceutical manufacturing companies have been nervously awaiting the fallout from major modifications in the US Pharmacopeial (USP) Convention’s Chapter 41 minimum quality standards for weights and balances. The Chapter 41 standard, previously used in assays to determine drug content and potency, was last updated more than 20 years ago. A global team of experts drafted the new version, which was recently approved for release by the USP and which officially comes into effect in December 2013.
The actual results from the methods detailed in the new standard will probably be in a range similar to those in the previous standard, but the techniques required and the wording of the standards are more complex. While some have suggested that the modifications require the purchase of expensive, new high resolution measuring equipment or services from outside parties, in fact many laboratories can easily and efficiently comply using their existing equipment – if they understand the nuances of Chapter 41 and follow a few simple guidelines.
With the help of panels of experts, USP regularly updates and modifies the standards it sets for the identity, strength, quality and purity of medicines, food ingredients and dietary supplements manufactured, distributed and consumed worldwide.1 Chapter 41, which covers the minimum accuracy of weights and balances used to perform assays, was one of a few that had remained unchanged for 20 years.
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