Information
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Audit Title
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Lead Inspector:
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Inspectors:
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Conducted on
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Area
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Rooms
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Area Supervisor (If Accompanied):
Section I
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Instructions /Notes:
1. Inspector to print pages 1-6 as needed depending on numbers of rooms inspected. Please enter all information and observations noted on the QPIP SharePoint.
2. Area Supervisor: Please update the QA PIP Walk through Form with any comment and/or work orders.
3. All work orders/comments generated, the QA PIP team must follow up and see that all issues are resolved.
Personnel
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Employees wearing appropriate gowning (no visible hair).<br>
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Employees wearing appropriate PPE (if applicable).
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Other:
Room
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Ceiling/floors/walls/doors/work areas (no holes, cracks, paint chips, scuff marks).
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All ceiling lights operational.
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All insulation free of cracks.
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Area (carts, desktops, tables, cabinets) clean, organized and uncluttered.
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All sanitants/reagents properly labeled and within expiration date.
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No trash on floor.
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Room sanitation logbook available.
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Other:
Equipment
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Equipment calibrations within calibration due dates.
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Equipment logbooks available.
Production/Process Controls
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Appropriate room status tag posted on door.
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Materials for different batches are segregated.
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Other:
Records/Documentation
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SOP binders available in room.
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No uncontrolled documents in the room (post-it notes, calculations, scrap paper).
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Logbooks (room, room changeover, equipment) filled out properly following cGMP's.
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Other:
Safety
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Floor and stairs free of slipping/tripping hazards.
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Floor not wet or wet floor signs in place.
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Eye wash station in good visible condition (weekly activation performed).
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Fire extinguisher available and in good visible conditions (monthly inspection done).
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Biohazard containers properly labeled (if not in use, lids in place).
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Other:
Section II
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Deficiency Description (provide as much detail as possible) - N/A table if no deficiencies.
Add Description
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Room
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Section Number
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Deficiency Desciption
