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Download the guide on regulatory compliance in pharma to get answers to your open questions. |
Density and refractive index are routinely measured in the quality control of many consumer products. The pharmaceutical industry poses especially high requirements when it comes to reliable measurements and data integrity. Strict legal regulations, standards, and pharmacopeia have been put in place by regulatory bodies to increase customer safety. It is important for every pharmaceutical laboratory to fulfill the highest accuracy standards to ensure compliance, be it for density or refractive index measurements or results documentation.
METTLER TOLEDO density meters and refractometers help support top-level accuracy and compliance with various regulations, standards, and pharmacopeia. This guide leads you through the current requirements and walks you through the solutions offered by METTLER TOLEDO.
Download this guide to answer your open questions concerning regulatory compliance, efficient and reliable analyses, and modern laboratory software.
First, pharmacopeia regulations are discussed, followed by how you can ensure your instruments to perform optimal measurements. Regular performance checks are the first step to precise and repeatable analyses. Following the “Good Density and Refractometery Practice (GDRP)™”, which are guidelines on how to use METTLER TOLEDO instruments to their fullest potential, is the recommended way to produce accurate and reliable results. The METTLER TOLEDO Laboratory software LabX™ supports you in complying with the highest data integrity standards according to FDA 21 CFR part 11, offering user management and a full audit trail. In addition, central data storage and instrument management of your METTLER TOLEDO Excellence instruments even beyond density meters and refractometers are enabled.
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