White Paper | November 15, 2013

Don't Get Blindsided By New USP Quality Standards

Source: Sartorius Stedim Biotech

What to do (and what you don’t have to do) for measurements to meet new accuracy requirements

By Dirk Ahlbrecht, Sartorius Group

The U.S. Pharmacopeial Convention’s (USP’s) Chapter 41 minimum quality standards for weights and balances have been updated after twenty years – and every pharmaceutical manufacturer has been waiting to see what that means in practice when the standards go into effect in December 2013.

The Chapter 41 standards are used to make sure pharmaceutical manufacturers use “accurate” weighing equipment, for example, in assays to determine drug content and potency. It’s important to say right at the outset that the actual results you will get using the new weighing standards will mostly be very similar to those from the old standard, but the measurement techniques required and how you document compliance with the standards is a bit more involved than in the past.

One thing is certain – many laboratories can easily and efficiently comply themselves, using their existing equipment, if they take the time to understand the nuances of Chapter 41 and follow a few simple guidelines. Don’t get scared into purchasing expensive new high resolution measuring equipment or services from outside parties!


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