European Pharmacopoeia General Chapter 2.1.7 Balances (10.6)

European Pharmacopeia Chapter 2.1.7 Publication Schedule

Webinar: Compliance with Ph. Eur. Chapter 2.1.7

This webinar explains the new European Pharmacopoeia General Chapter 2.1.7 "Balances for Analytical Purposes". For compliant weighing, balances must be calibrated periodically, including measurement uncertainty, and performance checks for repeatability and accuracy are a requirement.

Watch the Webinar on Ph. Eur. Chapter 2.1.7

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:

States that the calibration results must be documented in a calibration certificate and must include measurement uncertainty.
Highlights the importance of as found and as left calibration.
Focuses on best practices for installation and usage of the instruments.
Supports life-cycle management comprised of calibration and performance verification based on specific tests and acceptance criteria.

When will the Ph. Eur. General Chapter 2.1.7 be legally binding?

After a 6-month transition phase, the chapter is legally binding and is enforced in the framework of GMP audits by regulatory bodies from January 2022 onwards.

How can METTLER TOLEDO support you?

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

Have a Look at a Sample Certificate

Who is affected by Ph. Eur. General Chapter 2.1.7?

The European Pharmacopoeia (Ph. Eur.) is the single reference work for the quality control of drugs in 39 European countries. It is therefore also binding for pharmaceutical companies in other regions of the world who intend to export into the European market. As such, it has a similar legal status to the USP Compendium in the United States and is enforced by regulatory bodies as part of compliance with Good Manufacturing Practice.

The scope of the General Chapter 2.1.7 covers balances for analytical purposes. Therefore, any weighing described in a monograph of the European Pharmacopoeia must comply with the principles of the chapter.

Note: Ph. Eur. is a reference work for quality control of drugs, the chapter is not applicable for the manufacturing of pharmaceuticals.

The general chapter addresses equipment performance and introduces three measures that need to be carried out periodically to control and improve the performance of the balance:

Calibration including measurement uncertainty (this is a must)
Performance checks carried out between calibrations (this is a must)
Adjustment of the balance by means of built-in weights (this is an accepted practice)

The combination of these three pillars allows for an effective and efficient risk-based quality management and assessment of the balances against defined acceptance criteria (0.10%) and is perfectly in line with METTLER TOLEDO’s GWP® – Good Weighing Practice, the scientific standard for the life-cycle management of weighing instruments. GWP supports you in implementing Ph. Eur. Regulations on weighing and includes professional installation and qualification, calibration and routine testing. Our Accuracy Calibration Certificate in combination with the certificate "European Pharmacopoeia General Chapter 2.1.7 Balances for Analytical Purposes" documents the assessment of the balance against the requirements stipulated for precision and accuracy, while GWP Verification creates the quality framework under which the individual tests and assessments are conducted and documented. It provides a clear risk-based test strategy on suggested frequencies for calibration and the individual routine tests. Therefore, GWP Verification creates the quality framework under which the individual tests and assessments are conducted and documented.