An Easy Method To Conduct An Analytical Method Transfer
Posted by JohnMurphy on May 15th, 2020
Analytical method transfer is a critical step in drug development. This is a regulatory as well as scientific necessity that underlines the robustness and reproducibility of the obtained data. It forms a documented process that qualifies the receiving laboratory to reproduce a method that originated in the transferring laboratory.
Both of these laboratories can have varying relationships. For example, they may be the sponsor and CRO, two laboratories working on the same development, or other similar relationship. It must be noted that method transfer is neither easy nor simple. However, the pain points can be minimized through ample documentation and careful strategizing of the method.
Pointers For Conducting A Successful Analytical Method Transfer
Scientific and technical nitty-gritty aside, it is often communication issues that become the bottleneck for method transfer. It is important to understand that transfer is not a simple routine. A validated method isn’t necessarily one that will transfer easily.
The Sending Unit (SU) and the Receiving Unit (RU) must utilize channels of open and clear communication beyond the documentation. Proper utilization of defined processes, the ability to foresee pitfalls, and information for setup are all important.
Site Evaluation And Equipment
The RU has to verify that it has all the equipment required for method testing. This equipment is then verified to check if it is qualified for testing. Additionally, the equipment calibration should be done to achieve compliance with regulatory as well as applicable method necessities.
The presence of lighting sources, sunlight, temperature and humidity controls, and other environmental factors are considered. The receiving laboratory may also consider the use of reagents and vendors or grades used.
Training of personnel from the RU by SU may be required. If this is indeed necessary, the sending unit should make adequate arrangements for training. Various methods are available for analyst training. While on-paper training can suffice in many cases, some will require hands-on training.
Documentation And Due Diligence By Receiving Laboratory
Detailed documentation must be available to the receiving laboratory. Ideally, the transfer package includes analytical data, method validation reports, reports of previous transfers (if any), and robustness criteria. Performance under validation and standard operating procedures (SOPs) are involved as well. Details on quality control and stability data are essential aspects.
The RU performs due diligence on the transfer package and related documentation. A study of the methods, procedures, and documentation involved makes it possible to identify issues at an early stage. This enables identification and discussion of possible issues before the execution of the method transfer.
Also See: Method Transfer, Analytical Method, Receiving Laboratory, Transfer Package, Transfer, Method, Ru
Transfer And Validation
Suitable strategies can be used for successful method transfer. These include:
· Comparative Testing: This is the most common method for analytical method transfer. Set of samples from SU and RU are analyzed to ensure results remain within acceptable criteria and variability.
· Co-validation: This takes a multisite approach. The RU performs some aspects of method validation in conjunction with the SU with the aim of reproducibility testing.
· Revalidation or Partial Revalidation: This is a wider and more thorough process of method transfer. It is generally utilized when the SU is unable to directly participate in the transfer.
The generation of a transfer report usually forms the last step of the method transfer. Check that this report matches pre-established acceptance criteria with the transfer data.
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