Know-How

European Pharmacopoeia Chapter 2.1.7

Ensure compliance with "Balances for analytical purposes" The new General Chapter 2.1.7 "Balances for analytical purposes" was published in July 2021 as part of the European Pharmacopoeia (Ph. Eur.), Supplement 10.6.

What is new?

General chapter 2.1.7:

  • Specifies that calibration results including measurement uncertainty must be documented in a calibration certificate.
  • Highlights the importance of "As Found" and "As Left" calibration.
  • Focuses on best practices for instrument installation and use.
  • Supports life cycle management that includes calibration and gauge monitoring based on specific testing and acceptance criteria.

When will General Chapter 2.1.7 of Ph. Eur. become legally binding? 

After a six-month transition period, the chapter will be legally binding and enforced by regulatory authorities during GMP audits starting in January 2022.
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How can METTLER TOLEDO support you?

As the calibration of balances is a mandatory requirement of General Chapter 2.1.7, METTLER TOLEDO introduces the new certificate "European Pharmacopoeia General Chapter 2.1.7 Balances for Analytical Purposes". The certificate documents the evaluation of a balance against the requirements for precision and accuracy. This evaluation is also available in an independent document on the identical requirements specified in USP General Chapter 41.


Who is concerned by General Chapter 2.1.7 of the Ph. Eur.

The European Pharmacopoeia (Ph. Eur.) is the only reference work for the quality control of medicinal products in 39 European countries. It is therefore also binding for pharmaceutical companies in other regions of the world that intend to export products to the European market. As such, it has a similar legal status to the USP Compendium in the USA and is enforced by regulatory authorities as part of Good Manufacturing Practice compliance. 

 

You can find more information here.

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