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