How Can Weighing Compliance with New European Pharmacopoeia Chapter 2.1.7 Balances for Analytical Purposes be Achieved?

The new European Pharmacopoeia (Ph. Eur.) General Chapter 2.1.7 'Balances for Analytical Purposes' is published in Supplement 10.6 on 1 July 2021. It is a mandatory requirement for the quality control of medicines in European member states, or for any pharmaceutical company who exports into the European market, with a similar legal status to the USP compendium in the United States.

This new white paper ‘Weighing According to Ph. Eur.’ from Mettler-Toledo explains what is required by the new Chapter 2.1.7 'Balances for Analytical Purposes'. 

It covers the scope, main principles, and the role of calibration in a quality management system. It also describes in detail the specific performance checks (also known as routine tests) which will soon be required by European Pharmacopoeia in order to assess the accuracy and precision of a weighing instrument. 

It also describes the similarities and differences between the Ph. Eur. and USP requirements. Although Ph. Eur. 2.1.7 includes the same performance tests and criteria as USP General Chapter 41, the European Pharmacopoeia Chapter explicitly states that calibration should include a statement of measurement uncertainty and emphasises the concept of as found as left calibration. A definition of minimum weight is also given.

Compliance with Ph. Eur. Chapter 2.1.7, with regards to calibration, performance checks and the life-cycle management defined within this chapter, is mandatory when working according Ph. Eur. monographs.

After the 6-month transition period, any manufacturer or exporter of pharmaceuticals into the EU must be fully compliant with the new regulations by 1 January 2022. Are you ready? 

Read the white paper "Weighing According to Ph. Eur." to learn more.

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