Reference materials are one of the critical components of the analytical testing workflow. Through calibration of measurement systems, validation of approaches, and quality control programs, reference materials make sure that there is accuracy in testing. From certified reference materials and other various quality grades of reference materials to certificates of analysis, metrological traceability and other concepts, the world of reference materials is typically vast, and at times, confusing too.
These charts present critical reference material topics, which provides information on metrological traceability, the hierarchy of reference materials, certificates of analysis, reference material formats and uses, and fit-for-purpose selection considerations. Appropriate selection of the right reference material for the laboratory’s testing application is essential because results are only as accurate as your reference.
Unquestionably, the laboratories are needed to offer proof that the materials used for method validation and process controls are objective, uniform and stable. Certified Reference Materials (CRMs) are particularly structured to meet these strict standards. According to the regulatory standards of ISO continue to increase, an additional burden is placed on laboratories to ensure the quality and safety of completed products. At present more than ever, tracking has become a major problem.
To become a licensed and certified reference materials manufacturer, the manufacturer’s methods must meet the necessities of ISO. To obtain an ISO Accreditation, the manufacturer needs to demonstrate that they can offer CRM.
Here are some advantages that are beneficial to consider:
•As technology advances over time, the ability and requirement to measure more and more precisely increase.
•This drives the need for better identification tools that can be used in testing and evaluation.
•CRMs offer metrological tracking and known uncertainty of item prices.
•CRMs can make sure reliable user ratings. Tracking is usually provided by a certificate that reports the prices of the products, the uncertainty, and the approved Certifying body.
•CRM users are responsible for determining whether CRM is suitable for its intended use.
•The user must follow all the label instructions given by the CRM manufacturer.
What Is Measured In Each Grade Of Reference Material?
The purity and identity of the material are usually included in the Certificate of Analysis for each of the five quality grades. The content and stability are needed for the primary standards or ISO-defined CRM and RM.
Analytical standards and research chemicals may or may not cover these two parameters as their inclusion is dependent on the producer. Analytical Standards can also in few scenarios be Quality Control materials compliant with ISO Guide.
Undoubtedly, homogeneity is needed for the primary standards, CRM, and RM, but this parameter will not be set up with the lower quality grades. Uncertainty and Traceability information is restricted to just the primary standards and CRM. In the pharmaceutical world, secondary standards can be CRMs or RMs, but here, there are two distinct kinds of traceability to the SI unit of measurement for the ISO-defined CRM as well as traceability to the prime compendial standard, which is a requirement detailed to pharmaceutical secondary standards.