Be Compliant with New Ph. Eur. Chapter 2.1.7 on Weighing
Jul 13 2021
The new European Pharmacopoeia (Ph. Eur.) General Chapter 2.1.7 'Balances for Analytical Purposes', published on 1 July 2021 (Supplement 10.6), puts a focus on balance calibration, performance checks and lifecycle management. Any pharmaceutical company operating in or exporting into European member states, must comply with these new regulations by January 2022.
The Ph. Eur. General Chapter 2.1.7, in accordance with the United States Pharmacopeia (USP) General Chapter 41, is a legally binding reference work for the quality control of drug substances. It focuses on lifecycle management of analytical balances when working on test procedures according Ph. Eur. monographs. Calibration is mandatory and should be documented, along with the measurement uncertainty, in a calibration certificate. Furthermore, performance checks (also known as routine tests) must be carried out between calibrations.
A new white paper "Weighing According to Ph. Eur." explains exactly what is required by the new Chapter 2.1.7 'Balances for Analytical Purposes'.
The role of calibration in a quality management system is explained in detail, along with the requirements of as-found and as-left calibration, the importance of measurement uncertainty and the significance of minimum weight.
The white paper also describes in detail the specific performance checks (also known as routine tests) required by European Pharmacopoeia in order to assess the repeatability and accuracy of a weighing instrument, with acceptance criteria of 0.10%.
The balance chapters of USP 41 and Ph. Eur. 2.1.7 are directly aligned with GWP® (Good Weighing Practice) – the scientific standard for the life-cycle management of weighing instruments from METTLER TOLEDO. So GWP® can support you to easily implement the new weighing requirements, including calibration and routine testing (performance checks) and lifecycle management. It can also help you to prove that you are compliant with the regulations during an audit, by providing the appropriate documentation.
- The Accuracy Calibration Certificate (ACC) quantifies the performance (measurement uncertainty) of your balance over its entire weighing range.
- In addition to the calibration certificate, we provide certificates USP 41 and Ph. Eur. 2.1.7, which fully comply with USP and Ph. Eur. General Chapters. These certificates document the assessment of the balance against the stipulated tests (repeatability & accuracy) and include a compliance statement concerning the acceptance criteria of 0.10%.
- GWP® Verification helps you to define the appropriate intervals for calibration and performance checks based on your own quality considerations and the risk of specific applications. It provides you with a calibration and routine testing plan and it gives you guidance on routine testing methods, frequency and test weights and tolerances.
The new chapter 2.1.7 was published on 1 July 2021. After a 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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