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Cleaning Validation Glossary


A substance that aids in the manufacture of pharmaceutical ingredients

Excipient is defined in PDA TR 67 and 88 as "Inactive pharmaceutical ingredients in a product formulation that are responsible for the product’s manufacturability and physicochemical attributes". Some examples of excipients are binders, dyes, sweeteners, lubricants, and perservatives. EMA Guideline on Excipients in the Dossier for Application for Marketing Authorisation of a Medicinal Product provides guidance on excipient selections and handling.

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