Are you working in quality control in the pharmaceutical industry? Is your company located in Europe or exporting to Europe? Then the European Pharmacopoeia General Chapter 2.1.7 is relevant to you. So, what is the scope of this chapter? The European Pharmacopoeia General Chapter 2.1.7, Balances used for analytical purposes, addresses equipment performance and introduces the following three measures that must be carried out: Calibration including measurement uncertainty, this is mandatory. Performance checks carried out between calibrations, this is mandatory. Adjustment of the balance by means of built-in weights, this is an accepted practice. METTLER TOLEDO services supports your compliance of the regulation. Our Accuracy Calibration Certificate in combination with the certificate Ph. Eur. General Chapter 2.1.7. documents the assessment of a balance against the requirements stipulated for repeatability and accuracy, acceptance criteria 0.10%. While GWP Verification creates the framework under which individual tests and assessments are conducted and documented. Learn more about the scope of the chapter, the regulatory requirements and how METTLER TOLEDO can help you, find out more below. Ph. Eur. Scope 0:17, Compliance 1:13, Calibration & Certificate Ph. Eur. 1:52, Performance Checks 2:14. The European Pharmacopoeia General Chapter 2.1.7, "Balances used for analytical purposes", addresses equipment performance and introduces the following three measures that must be carried out: Calibration including measurement uncertainty, this is mandatory. Performance checks carried out between calibrations, this is mandatory. Adjustment of the balance by means of built-in weights, this is an accepted practice. METTLER TOLEDO services supports your compliance of the regulation. Our Accuracy Calibration Certificate in combination with the certificate Ph. Eur. General Chapter 2.1.7 documents the assessment of a balance against the requirements stipulated for repeatability and accuracy, acceptance criteria 0.10%. Learn more about the scope of the chapter, the regulatory requirements and how METTLER TOLEDO can help you, find out more below. Ph. Eur. Scope, 0:17. Compliance, 1:13. Calibration & Certificate Ph. Eur., 1:52. Performance Checks, 2:14. Both tests have an acceptance criterion of the error of 0.10%. So how can you ensure compliance with the new chapter? Well, this is a very simple answer with good weighing practice program called GWP. Our GWP program covers all pillars stipulated in the chapter 217. Calibration. The European Pharmacopoeia General Chapter 2.1.7. "Balances used for analytical purposes" addresses equipment performance and introduces the following three measures that must carried out: - Calibration including measurement uncertainty - Performance checks carried out between calibrations - Adjustment of the balance by means of built-in weights METTLER TOLEDO supports your compliance of the regulation. Our Accuracy Calibration Certificate in combination with the certificate "Ph. Eur. General Chapter 2.1.7." documents the assessment of a balance against the requirements stipulated for repeatability and accuracy. Learn more about the scope of the chapter, the regulatory requirements and how METTLER TOLEDO can help you, find out more below: The European Pharmacopoeia General Chapter 2.1.7, Balances used for analytical purposes, addresses equipment performance and introduces the following three measures that must be carried out. Calibration including measurement uncertainty, this is mandatory. Performance checks carried out between calibrations, this is mandatory. Adjustment of the balance by means of built-in weights, this is an accepted practice. METTLER TOLEDO services supports your compliance of the regulation. Our Accuracy Calibration Certificate, ACC, in combination with the certificate Ph. Eur. General Chapter 2.1.7, documents the assessment of the balance against requirements stipulated for repeatability and accuracy. Furthermore, 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 gives you guidance on methods, frequency, test weights and tolerances. These services ensure compliance with the European Pharmacopoeia General Chapter 2.1.7. Get ready for the changes. The European Pharmacopoeia General Chapter 2.1.7. Balances used for analytical purposes addresses equipment performance and introduces the following three measures that must carried out: - Calibration including measurement uncertainty - Performance checks carried out between calibrations - Adjustment of the balance by means of built-in weights METTLER TOLEDO services supports your compliance of the regulation. Our Accuracy Calibration Certificate in combination with the certificate Ph. Eur. General Chapter 2.1.7. documents the assessment of a balance against the requirements stipulated for repeatability and accuracy, while GWP Verification creates the framework under which individual tests and assessments are conducted and documented. Learn more about the scope of the chapter, the regulatory requirements and how METTLER TOLEDO can help you, find out more below:
What Is the Scope of the Pharmacopoeia General Chapters
The Pharmacopoeia General Chapters address equipment performance and introduce measures that must be carried out periodically to optimize balance performance:
- Calibration must be documented in a calibration certificate and must include measurement uncertainty.
- Repeatability and Accuracy are the two performance checks that must be executed between calibration intervals.
- Highlight the importance of “as found” and “as left”.
Furthermore, the Pharmacopoeias recommend applying adjustment by built-in weights.
Please note: These chapters and the requirements in them only apply to pharmaceutical quality control. They are not applicable to pharmaceutical manufacturing.
