Certificates USP 41 and Ph. Eur. 2.1.7.
Ensure Compliance in the Pharmaceutical Industry
USP and Ph. Eur. chapters are legally binding for all pharmaceutical companies in the US and Europe as well as companies that import pharmaceutical products to the US and Europe. As such, USP and Ph. Eur. requirements are enforced in the framework of GMP audits performed by regulatory bodies.
Both chapters focus on lifecycle management of analytical balances used for quality control of drugs and state that calibration is mandatory.
METTLER TOLEDO certificates USP 41 and/or Ph. Eur. 2.1.7., in combination with our Accuracy Calibration Certificate, provide you with physical evidence that you fulfill the requirements.
What is the Scope of USP 41 and Ph. Eur. 2.1.7.?
General Chapters USP 41 and Ph. Eur. 2.1.7. cover balances used for analytical purposes in the pharmaceutical industry. Both chapters address equipment performance and introduce three measures:
- Calibration results must be documented in a calibration certificate including measurement uncertainty (this is a must)
- Performance checks/routine testing carried out between calibrations – repeatability & accuracy tests with an acceptance criterion of 0.10% (this is a must)
- Adjustment of the balance by means of built-in weights (this is a state-of-the-art practice)
Please note: These chapters and the requirements in them only apply to pharmaceutical quality control. They are not applicable for pharmaceutical manufacturing.
Download the White Paper to learn more about the required test and acceptance criteria
Services to Ensure Compliance
In combination with the Accuracy Calibration Certificate (ACC), which documents the calibration including measurement uncertainty, METTLER TOLEDO offers two Pharmacopoeia certificates to ensure regulatory compliance.
The certificates USP 41 and Ph. Eur. 2.1.7. document the assessment of the balance against the stipulated tests (repeatability & accuracy) and include a compliance statement concerning the acceptance criteria of 0.10%.
Your Concrete Quality Assurance Plan
Chapters USP 41 and Ph. Eur. 2.1.7. governing balance use are aligned with METTLER TOLEDO's Good Weighing Practice (GWP®). GWP is a global weighing standard for the secure selection, calibration and routine operation of balances and scales. It helps to ensure consistent quality and the full compliance of your weighing processes to reduce your operating costs.
Our GWP® Verification will define your quality assurance plan for applying USP and Ph. Eur. in your weighing processes. Based on a risk assessment, GWP Verification defines your calibration and service frequency as well as your routine testing plan (including the frequency, methods, test weights and tolerances).
Watch our Webinar to learn more about how GWP ensures Pharmacopoeia compliance
Library
Learn More
Consistent Weighing Results with Calibration
Only regular calibration lets you know how accurate your weighing results actually are. Read more
Your Individual Routine Testing Plan
Get your routine testing plan, including test frequency, methods, weights and tolerances. Read more
What is Good Weighing Practice™?
GWP® helps to ensure consistent quality, reduced costs and full compliance in any weighing process. Read more
FAQs
1. Who needs to comply with USP 41 and Ph. Eur. 2.1.7?
Ph. Eur. 2.1.7 applies to quality control of drugs in European countries. It is also binding for pharmaceutical companies in other regions of the world who intend to export to the European market. USP 41 applies to quality control of drugs in the US. It is also binding for pharmaceutical companies in other regions of the world who intend to export to the US.
2. How does the (Accuracy Calibration Certificate) ACC fulfill the calibration requirements of Ph. Eur. Chapter 2.1.7.?
Typically, a calibration certificate indicates measurements for repeatability, eccentricity and error of indication. The ACC provides results for all these parameters, including:
- Measurement uncertainty
- As Found/As Left performance of the weighing instrument
The ACC indicates the measurement uncertainty for error of indication test points. Indication of measurement uncertainty in a calibration certificate is stipulated by Ph. Eur. General Chapter 2.1.7. In addition, the ACC always indicates the As Found/As Left test results in compliance with General Chapter 2.1.7.
Note that ACC does not provide the specific assessments for precision and accuracy including a statement of compliance with Ph. Eur. General Chapter 2.1.7. This is covered by the Certificate Ph. Eur. General Chapter 2.1.7.
3. Does General Chapter 2.1.7. affect only analytical balances or balances used for analytical purposes in general?
There is an official definition: An analytical balance starts with a readability of 0.1 mg or smaller.
However, the framework of the pharmacopoeia regulations considers devices that are used for analytical purposes. If you use a precision balance for analytical purposes (which is rare but might occur) then the precision balance would also have to follow USP and European Pharmacopoeia regulations.
4. How often do I have to perform the performance checks (according to Ph. Eur. 2.1.7.)?
General Chapter 2.1.7 stipulates that specific performance checks must be carried out in-between calibrations. While calibrations are usually performed annually or in intervals of three to six months, performance checks are typically performed more often, depending on the risk of the application and the quality requirements of the user. However, it is still left up to each company to define appropriate intervals for calibration and performance checks based on their own quality considerations and the risk of their specific applications. GWP® Verification fills this gap and provides a clear risk-based test strategy for suggested calibration frequencies, the individual routine tests, test weights, test weight classes, and test weight recalibration intervals.