Monday, 23 March 2020

Analytical method transfer and the supplier change processes for Bacterial Endotoxin Testing



LAL testing is an established part of many QC microbiology laboratories, and subject to the similar test protocols and assay requirements as with other analytical methods, albeit with the wider acceptance criterion that reflects the test’s status as a biological assay. With such laboratory methods there will be times when a laboratory will either need to transfer an existing method between one laboratory an another or where the core reagent needs to be changed; both scenarios require a reassessment of previously assessed samples. This article, in considering analytical method changes, uses the LAL test (specifically a photometric test method) as an example of how a method can be transferred.

In relation to this, Tim Sandle and Kerry Skinner have written an article. Here is the abstract:

A key objective is with any method transfer or change is ensuring that product and process knowledge is captured. Challenges with this process can arise because of poor analytical method robustness; where differences in analytical technology that have not been duly considered; due to different working cultures; or where there are differences in ways of working between laboratories or alterations that are required in relation to different methodologies. Such issues are more likely when a method is transferred but problems can also arise when a reagent changes, especially where the replacement reagent is inferior. The important aspect will both scenarios is in taking time to plan the change process.


The reference is:

Sandle, T. and Skinner, K. (2019) Analytical method transfer and the supplier change processes for Bacterial Endotoxin Testing, European Pharmaceutical Review, 24 (5): 54-57

The article can be accessed here: https://www.europeanpharmaceuticalreview.com/article/103589/european-pharmaceutical-review-issue-5-2019/

For further details, contact Tim Sandle

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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