Audit - 16

Audit Manual 16 - Auditing a Material Handling System

Perform an audit of a material handling system. Use a range of tools and information, including the contents of this unit to support the audit of a material handling system. Understand and apply appropriate GMP standards/regulations to an audit of a materi

Audit 16 - Auditing a Material Handling System

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Material handling starts when components and packaging materials are received onto a pharmaceutical or Active Pharmaceutical Ingredient (API) plant site and ends when the product/material is distributed. Material includes components or starting materials, (e.g., raw materials), API intermediates and excipients and packaging materials used for APIs or finished products.

The goal of this training module is to describe how to audit a material handling system using the appropriate GMP standards. The GMP requirements detailed in this module are directly applicable to finished dosage and API manufacturing sites and should be applied to other suppliers on a sliding scale, the scale being dependent on the product or service being audited. In addition, the auditor should consider the risks associated with the material handling system that would potentially result in product not meeting customer specifications or regulatory requirements.

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