Audit - 21

Audit Manual 21 - Auditing an Excipient Supplier

Perform an audit of an excipient vendor. Use a range of tools and information, including the contents of this unit and the Internet, in support of auditing an excipient vendor. Understand and apply applicable GMP standards and site standards to an audit of

Audit 21 - Auditing an Excipient Supplier

Many excipient materials are also used in industries other than the pharmaceutical industry, including food, cosmetic or industrial products. In many cases excipients are foodstuffs, food additives, or food preservatives that are also used in pharmaceutical products. Most pharmaceutical excipient manufacture is less than 10 percent of the production of the material. In most cases, the material is produced in bulk and is a low margin product. Excipient manufacturing processes are often similar to those for chemical APIs. Excipients are often manufactured on a large scale utilizing continuous processing and automated process controls. Facilities may consist of large tanks; production facilities and equipment will vary depending upon the type of excipient being manufactured, the scale of production and the type of operations (batch processing vs continuous processing).

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