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Pharmacopoeia Certificates in Laboratory Weighing

Ensure Compliance in the Pharmaceutical Industry

Several Pharmacopoeias around the world have dedicated chapters about the usage of balances in pharmaceutical quality control (e.g. USP, Ph. Eur., JP). These chapters are legally binding for both local pharmaceutical companies and importers to the respective countries where they are enacted. They specifically target users working in pharmaceutical quality control who use balances for analytical purposes. As such, these requirements are enforced in the framework of GMP audits performed by regulatory bodies.

METTLER TOLEDO’s various Pharmacopoeia Certificates for Laboratory Weighing, in combination with our Accuracy Calibration Certificate, provide you with physical evidence that you have fulfilled the requirements.

Pharmacopoeia Certificates
Pharmacopoeia Certificates

What Is the Scope of the Pharmacopoeia General Chapters

The Pharmacopoeia General Chapters USP 41, Ph. Eur. 2.1.7., and JP 9.62 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.

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 calibration, including measurement uncertainty, METTLER TOLEDO offers various Pharmacopoeia Certificates for Laboratory Weighing to ensure regulatory compliance.

They document the assessment of the balance against the stipulated tests (repeatability and accuracy) and include a compliance statement concerning the acceptance criteria of 0.10%.

Available for: USP 41, Ph. Eur. 2.1.7., and JP 9.62

Have a Look at a Ph. Eur. Sample Certificate

Have a Look at a USP Sample Certificate

Have a look at the JP Sample Certificate

Services to Ensure Compliance
Services to Ensure Compliance
Your Concrete Quality Assurance Plan
Your Concrete Quality Assurance Plan

Your Concrete Quality Assurance Plan

The Pharmacopoeia Chapters 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, Ph. Eur., and JP 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

Datasheet for Pharmacopoeia Certificates in Weighing

Certificates USP 41 & Ph. Eur. 2.1.7

in Laboratory Weighing

USP Chapter 41 weighing requirements

USP Chapter 41 Weighing Requirements

Weighing in Pharmaceutical Quality Control According to U.S. Pharmacopeia Guidelines

實驗室天平例行測試

天平和磅秤例行測試

如何確保每天都有正確的稱重結果？天平例行測試的相關實務

實驗室天平測試的標準作業程序

天平與磅秤測試的標準作業程序 (SOP)

天平靈敏度、偏載和重複性測試的相關建議

1. Who needs to comply with USP, Ph. Eur. 2.1.7., and JP 9.62?

The chapters are legally binding for both local pharmaceutical companies and importers to the respective countries where they are enacted. They specifically target users working in pharmaceutical quality control who use balances for analytical purposes. The chapters are not applicable to the manufacturing of pharmaceuticals.

2. How does the Accuracy Calibration Certificate (ACC) fulfill the calibration requirements of those Pharmacopoeia Chapters?

Typically, a calibration certificate indicates measurements for repeatability, eccentricity and error of indication. The ACC provides results for all these parameters, as well as:

  • Measurement uncertainty
  • As Found/As Left performance of the weighing instrument

The ACC indicates the measurement uncertainty for error of indication test points. The indication of measurement uncertainty in a calibration certificate is stipulated in the various Pharmacopoeias. In addition, the ACC always indicates the As Found/As Left test results.

Note that ACC does not provide specific assessments for repeatability and accuracy, including a statement of compliance with the various Pharmacopoeia Chapters. This is covered by the Certificate Pharmacopoeias.

3. Do the Pharmacopoeia Chapters 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, JP, and European Pharmacopoeia regulations.

4. How often do I have to perform the performance checks?

For example, 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, individual routine tests, test weights, test weight classes, and test weight recalibration intervals.