Supports Reference Standard Requalification
An area of expertise that supports reference standards is analytical method transfer (AMT). When a method is developed and validated at one laboratory, research scientists at MRIGlobal then test that method to prove that it can be run at a different laboratory. With our reference standard management programs, we are often transferring methods from several different laboratories to support standard requalification. This makes it critical that these methods of transfer are assessed, ensuring that accurate protocols are established and well-documented.
The process of AMT typically begins with a method feasibility assessment in which MRIGlobal staff attempt to execute the client method as written. This helps to identify any potential difficulties that may occur during method transfer. Once the feasibility of the method has been confirmed, a method transfer protocol is drafted. The protocol describes the testing to be done to prove that the method can be run successfully at the new laboratory. A method transfer protocol is similar to a method validation protocol, but typically has a smaller scope. For example, transfer of a chromatographic impurity profile method typically includes assessment of system suitability, sensitivity, specificity, and precision. For cGMP projects, the protocol is reviewed and approved by MRIGlobal technical staff, MRIGlobal quality assurance, and the client. Once the protocol is approved, the assessments can be executed.
Once the method transfer assessments are complete and all method transfer criteria are met, MRIGlobal will prepare a method transfer report. For cGMP projects, the report will be reviewed and approved by MRIGlobal technical staff and QA, then submitted to the client. The final version of the method for use at MRIGlobal will typically be attached to the method transfer report. Once the report is approved by all parties, the method may be performed at MRIGlobal for analysis of client samples, such as reference standards.
For a reference standard management program, method transfer typically needs to occur at the beginning of the program because the methods must be transferred before they may be used to qualify reference standards. However, transfer of individual methods may be staggered throughout the first few months or years of the program, if each method is transferred before the corresponding reference standard needs to be qualified.
For additional expertise on this topic, MRIGlobal’s John Cobb, program manager, and Audrey Ingram, Ph.D., senior chemist, offered a free webinar on essential insights into the qualification and distribution of reference standards, and the importance of developing a formal program for reference standard management. You can watch the webinar recording at “Reference Standard Management for Pharmaceutical Development.” You can also read about some of the questions we received about reference standards at “Reference Standards in the Pharmaceutical Industry.”
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Contact MRIGlobal for further information about our work in pharmaceutical sciences. Through a multidisciplinary approach, we provide customized pharmaceutical development solutions for government and commercial organizations. This includes expertise in pharmaceutical analysis, API manufacturing, clinical research support, repository management, and bioanalytical chemistry.
To discuss how we can help your project be successful, contact us today.
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