The most appropriate method is to use FDA’s risk-based approach, which evaluates each measurement according to such established risk analysis standards as those used in the failure modes and effects analysis (FMEA) approach, ensuring that the user will arrive at a proper and practical definition.Īs a manufacturer of premium lab balances, Sartorius has been thoroughly reviewing the challenges posed by the new Chapter 41 changes and has been assisting with interpretations to make compliance as easy as possible. In most cases, individual pharmaceutical manufacturers decide for themselves what needs to be weighed accurately within their own manufacturing environment. Larger manufacturers may have in-house metrology departments to help develop interpretations, but most rely on interpretation by manufacturers of weighing equipment. This is causing some concern, since USP standards usually require a fair amount of interpretation. The Food and Drug Administration (FDA) is responsible for enforcing the new USP Chapter 41 standards, which are used during inspections of US pharmaceutical companies and companies that wants to export products to the US. 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 themselves, using their existing equipment – if they understand the nuances of Chapter 41 and follow a few simple guidelines. The actual results will likely be similar to those in the previous standard, but the techniques required and the wording of the standards is a bit more complex. A global team of experts drafted the new version, which was recently approved for release by the USP, and officially goes into effect in December 2013.

The Chapter 41 standard, previously used in assays to determine drug content and potency, was last updated more than twenty years ago. Pharmacopeial Convention’s (USP’s) Chapter 41 minimum quality standards for weights and balances.

Pharmaceutical manufacturing companies have been nervously awaiting the fallout from major modifications in the U.S. Sartorius AG (USA) - How to use new balance standards to perform accurate measurements in the pharmaceutical industry, by Dirk Ahlbrecht, Sartorius Group and a member of the expert panel of US Pharmacopeia for chapters.

Usp 41 chapter 41