Without question, the most critical areas in any plant are where sterile products are made, often under aseptic conditions.
These are areas which the auditor must address in considerable detail, starting with the environment and how it is monitored. Obviously operating practices and how they are observed are critical, as are personnel matters and equipment and its cleaning. All of which must be satisfied during the audit.
~ Access to Aseptic Manufacturing Areas
~ General Overview of the Facility
~ Air Filtration and Pressure Differentials
~ Requirements for Areas within Aseptic Manufacturing
~ Equipment for Aseptic Manufacture
~ Monitoring of Aseptic Areas
~ Validation
~ Personnel
~ Filtration
~ Testing
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