Regulatory and Testing Requirements of the Bacterial Endotoxin Testing (BET) or LAL Program

Bacterial Endotoxin Test (BET) is a vital safety requirement in the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and the medical device quality system regulations. A solid grasp of the concept of this critical release assay, its application and importance to the manufacture of cGMP product is paramount. This helps avoid costly errors, batch disposal, expensive failure investigations and delays in the release of products that some manufacturers have undergone. This webinar has been designed to provide the experienced technician with an extensive understanding of how an Limulus amebocyte lysate (LAL) testing program can be applied to quality control so that regulatory requirements enforced by the EU and the FDA are met.

[santhosh-yvhu]

Could anyone tell me whats the reaction happening during the gel cloting other than coagulase reaction-?