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A Guide to Understanding and Performing all Appropriate Validation Steps When Adopting a New Endotoxin Testing Reagent

Limitations of Common Endotoxin Testing Solutions The adaptation of in-house endotoxin testing for a pharmaceutical or medical device manufacturer can be a daunting task. Many small-volume manufacturers find themselves in one of two common situations. Either they are utilising a contract testing organisation (CTO) and paying a great deal of costs, or they have adopted a solution that is set up by the manufacturer with much of the validation services outsourced.

A potential limitation of these methods is cost. Utilising a CTO is appealing to low-volume manufacturers. However, it can be a limitation to expansion as testing costs increase with volume. A system that does not allow versatility in reagent usage can lock the client into manufacturers’ costs and price increases.

However, an even bigger drawback to both situations is the lack of testing control and feedback that the user receives for each method. The disadvantage to the convenience of a contract testing service is the increase in time to results as well as greater limitations on the frequency of testing monitoring. In-house testing can provide results in an hour or less if needed. This nearly real-time feedback on the quality of the manufacturing process is invaluable to the trend monitoring of the manufacturing process.

Dangers of Improperly Performed Analytical Methods Validation

Real-time feedback can be provided by seemingly attractive solutions. Some solutions utilise outsourced verification data provided by the manufacturer. This provides the convenience of having preparatory tests being done offsite – outsourcing much of the validation. However, a great limitation of this method is that the routine testing takes place in a different location with different analysts, accessories, and accompanying instruments, which may not fully support the verification test requirements stated in USP chapter 85: “To assure the precision or validity of the turbidimetric and chromogenic techniques, preparatory tests are conducted to verify that the criteria for the standard curve are valid and that the sample solution does not interfere with the test. Validation for the test method is required when conditions that are likely to influence the test result change.” Although an outsourced standard curve may technically check the requirements, it assumes that changing “conditions that are likely to influence the test result” is not a factor between the different locations, personnel, equipment, and accessories in and with which the validation testing and the routine testing takes place.

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