FDA Revises Guidance on Safety Testing of Drug Metabolites

The US Food and Drug Administration (FDA) on Tuesday released revised guidance on recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated. The revisions mean the new guidance supersedes guidance from February 2008. The guidance has been revised to be in alignment with ICH [Read More...]

Relevance Of Microbial Finished Product Testing In Food Safety Management

Abstract Management of microbiological food safety is largely based on good design of processes, products and procedures. Finished product testing may be considered as a control measure at the end of the production process. However, testing gives only very limited information on the safety status of a food. If a hazardous organism is found it [Read More...]

Validation and Verification Of A Food Process

For many food products, validating and verifying a process sounds like a simple task if the product has been made for years and is considered very safe. In many of these cases, one immediately thinks about the time and temperature of a cook step. In other cases, one might think there is no process because [Read More...]

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