Audit - 11

Audit Manual 11 - Auditing Utilities System

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

Audit 11 - Auditing Utilities System

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To produce either a finished pharmaceutical, an API, an excipient, a medical device or packaging materials the environment within the plant has to be considered. One of the least noticed but important parts of producing a product free of contamination is the plant utility system. The system includes the heating, ventilation and air conditioning system (HVAC), the water system, the compressed gas system and the steam system, if used in the plant. Each of these systems must be qualified/validated.

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