Excipient Safety in the pharmaceutical industry

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Most excipients have been commercially available for many years. However, with the introduction of new analytical techniques, and increased understanding of the importance of how some minor components may increase the risks with the use of an excipient, the safety of each excipient may need to be reviewed periodically as our understanding of potential safety issues increases.

For new excipients safety is an important consideration. New in the context of excipients can mean a new chemical (highest safety risk) through different scenarios including co-processed materials to a new source of an existing grade (lowest safety risk). The category of 'new' excipient will strongly influence the extent of the necessary safety evaluation.

FinnBrit Consulting can provide advice for all aspects of the necessary safety evaluations for both new and existing excipients.

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