As the calibration of balances is a mandatory requirement of General Chapter 2.1.7, METTLER TOLEDO offers the 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.
The General Chapter 2.1.7 "Balances for Analytical Purposes" was published in July 2021 and it is legally binding since January 2022. 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. It has a similar legal status to the USP compendium in the United States.
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
Ph. Eur. 2.1.7 requirements describe the same tests and criteria as USP General Chapter 41.
This white paper explains all the elements of Chapter 2.1.7 "Balances for analytical purposes", including the scope, the main principles, the role of calibration in a quality management system, and what specific performance checks (also known as routine tests) are required to assess the accuracy and precision of a weighing instrument.
Who Is Affected by Ph. Eur. General Chapter 2.1.7?
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The European Pharmacopeia (Ph. Eur.) is the single reference work for the quality control of drugs in Europe. 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.
What is the scope of the Ph. Eur. General Chapter 2.1.7 “Balances for Analytical Purposes”?
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.
How can I ensure compliance with the new Chapter 2.7.1?
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 lifecycle 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.
I am compliant with USP 41, do I need also a Ph. Eur. Certificate?
Yes. Each certificate has dedicated statements to document compliance according to the specific pharmacopoeia. When references are made in the customer documentation, they can be specifically related either to Ph. Eur. General Chapter 2.1.7. or to USP General Chapter 41.
Does Ph. Eur. 2.1.7. require both 'as found' and 'as left' data in the calibration certificate?
It is not a mandatory requirement, but it is strongly recommended for traceability. If a calibration is carried out with no adjustment afterwards, it means that the as found calibration already fulfils the requirements of the European Pharmacopoeia. In this specific case, an as left calibration is obsolete and the as found calibration data are considered to be also as left calibration data.