Why do I need Good Measuring Practices?

If your results matter, Good Measuring Practices can help you produce accurate, high-quality results day in and day out. Our measuring expertise and scientific, transparent approach support you in choosing the instruments that are fit for your purpose and maintaining their accuracy over time.

Do Good Measuring Practices help me meet regulatory compliance requirements?

The GxP programs are developed on sound metrological principles and are based on current regulations and best practices. Experts from METTLER TOLEDO work with international and national committees to improve and develop new industry standards (e.g., ISO, USP, Ph.Eur., ASTM, OIML, EURAMET, ILAC, EURACHEM, and others).

The GxP programs help you document and prove that your instruments are fit for their intended use – as is required by every major quality standard and guideline such as ISO 9001, Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Global Food Safety Initiative accepted standards (BRC, SQF, etc.), and others. Furthermore, the individual GxP programs help you meet instrument-specific standards, such as USP 41, Ph.Eur. 2.1.7, OIML R76-1, EURAMET cg-18, and ASTM E898 for weighing (GWP) or ISO 8655 for pipetting (GPP).

How does a risk assessment help define calibration frequency?

Maintaining, calibrating, and testing your equipment can be a cumbersome and costly activity. Good Measuring Practices define the scope and frequency of performance verification activities based on the risk of your application. If the risk is high, more frequent calibration and testing can help to mitigate the risk. On the other hand, if the risk is low, minimal activities suffice and frequencies can be reduced. The GxP programs help you do a straightforward risk assessment and propose a specific maintenance and calibration plan for your needs.

When is an instrument fit for purpose?

An instrument is fit for purpose if it meets the requirements of its intended use. From a metrological perspective, it is fit for purpose if the measurement uncertainty of the result is equal to or lower than the required measuring tolerance. In weighing, for example, the GWP calibration certificate compares the measured uncertainty with the user-specified weighing tolerance and thus documents fitness for purpose. A similar evaluation using estimated uncertainties is made before the purchase of a new instrument in the GWP Recommendation document. 

What are important criteria to consider before purchasing a new instrument?

Many criteria depend on the specific measurement technology, but some apply to instrument selection in general:

  • What is my intended use?
  • What accuracy do I need to achieve?
  • Do I need to meet regulatory compliance requirements?
  • What is the risk of my application?
  • Where is the instrument located? Will it be affected by the environment?
  • How do I want to store my results?
  • Do I need a test and calibration plan/SOP?
  • What training do my users need?

Such requirements are documented in a GxP Recommendation that helps you make the right instrument selection.

Do Good Measuring Practices provide guidance on instrument qualification?

Yes. Maintaining traceability and accuracy of measuring results is a key benefit of Good Measuring Practices. Depending on your industry, the regulatory requirements, and the type of measuring technology, it can be challenging to know what qualification is needed and what is not. The GxP programs provide clear recommendations on what qualification activities are meaningful, based on your risk and compliance requirements.

Do Good Measuring Practices apply only to laboratory instruments?

No. Although a majority of the GxP programs focus on lab measuring instruments in R&D, quality control, and quality assurance, the scientific principles also apply to industrial production and packaging. GWP, for example, Good Weighing Practice, applies to any weighing device ranging from a microbalance to a tank scale of several tons.

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