GMDP Guideline. Reliable Results for Melting, Dropping and Softening Point

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1 GMDP Guideline GMDP Limit risks Minimize errors Improve quality Reduce costs Protect your investment Reliable Results for Melting, Dropping and Softening Point

2 Improve Lab Processes GMDP Background Information GMDP Good Melting and Dropping Point Practice is a 5-step guideline to improve your Lab process. It covers the entire lifecycle of your instrument and helps to improve quality while reducing risks and costs. GMDP makes sure that the right equipment is used in a suitable environment by appropriately trained operators. Required by melting point determination and especially in dropping and softening point tests the strict adherence to international standards such as Pharmacopeias, ASTM, ISO or IP is imperative to achieve consistent and comparable results. GMDP reduces the risks associated with melting and dropping point analysis and facilitates: Compliance with regulations Preservation of the accuracy and precision of results Increased productivity and reduced costs Professional qualification and training Why are Melting Point and Dropping Point in the same program? Both methods yield a thermal parameter based on the same general methodology: controlled heating of a sample until an exactly defined event is detected which is based on the phase transition from a solid to a liquid or semi-liquid state. The melting point is a unique parameter that can be used to identify a substance. The dropping or softening point is used to compare differ - ent batches of the same substance in order to obtain a quality control parameter. In both cases the selection of the best suitable instrument for the specific is an important step to minimize costs and improve quality. 2

3 One Click weighing solutions Dependable analytics Correct equipment used in a suitable environment by well-trained people is a prerequisite for reliable and repeatable results. GMDP Good Melting and Dropping Practice 3

4 Minimize Risks 5 Steps to Excellence For all 5 major steps of Good Melting and Dropping Practice METTLER TOLEDO offers comprehensive support, so that you invest in suitable equipment and services. Minimizing your risk will improve your performance. Step 1 Evaluation Step 2 Selection Step 3 Installation Based on a thorough analysis of sample properties and standards that determine the respective analytical standard operating procedure, GMDP compiles a recommendation for the most suitable analytical instrument solution. Secure the first few steps on the right path by using our professional consulting services and documentation of your requirements. Once your current and future needs have been clearly identified, the current analytical system can be selected. This includes not only the measuring instrument, but also software if required. Skilled members of the service team carry out the installation of the instrument. GMDP ensures that this process is efficiently processed according to comprehensive and well-established procedures. 4

5 Step 4 Qualification Step 5 Routine Operation After installation, the system has to be qualified for the operations it needs to fulfill. Professional commissioning and qualification of the analytical instrument is required. These activities need to be documented in a way that s easy to understand and traceable. GMDP particularly focuses on practical training in order to eliminate one of the major error sources in melting and dropping/softening point determination: sample preparation. In order to ensure measurement accuracy and reliability, GMDP recommends periodic preventive maintenance visits performed and documented according to application specific SOPs. Beyond that, GMDP provides professional training documentation to help to establish and maintain the training level regarding correct execution of the complete analytical workflow of the personnel operating the instrument. 5

6 Documentation and Validation Documented Processes Professional and Fast Professional commissioning, training, qualification and seamless documentation guarantee compliance with your process requirements from the very first step. DQ Design Qualification EQPac Equipment Qualification Package EduPac Education Package This tool helps you to define your current and future requirements together with our consultant, in order to select the most suitable system for your application and secure your investment for the future. EQPac is a comprehensive qualification solution, meeting the strictest regulatory demands and requirements. Detailed documentation with a professionally-executed qualification procedure ensures conformity and establishes complete traceability from the very start. Under the watchful eye of our specialist, this training package helps you to familiarize yourself with the instrument, and to learn efficient operation through practical exercises. Configuration and setup Calibration & Adjustment Structure of methods and analyses 6

7 LabX software validation METTLER TOLEDO supports you, providing validation of the LabX software. Validation service On-site support for validation. Re-validation service Information package including all forms required for re-validation following LabX upgrade or update. Validation manual I Contains all information required for qualification of METTLER TOLEDO as a software manufacturer. Validation manual II Contains all regulations and forms required to perform LabX validation. 7

8 The Right Tool for Every Step Step Tool 1 Evaluation Design Qualification 2 Selection Design Qualification 3 Installation EQPac (Equipment Qualification Package) 4 Qualification EQPac (Equipment Qualification Package) LabX validation manual I LabX validation manual II 5 Routine Operation EduPac (Education Package) Get an Idea of Your Risk Perform your own risk check with our web-based tool: For more information Mettler-Toledo AG, Analytical CH-8603 Schwerzenbach, Switzerland Tel Fax Quality certificate. Development, production and testing according to ISO Environmental management system according to ISO Subject to technical changes 10/2013 Mettler-Toledo AG, Marketing MP/DP / MarCom Analytical European conformity. The CE conformity mark provides you with the assurance that our products comply with the EU directives.