Section I

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

Employees wearing appropriate gowning (no visible hair).

Employees wearing appropriate PPE (if applicable).

Other:

Room

Ceiling/floors/walls/doors/work areas (no holes, cracks, paint chips, scuff marks).

All ceiling lights operational.

All insulation free of cracks.

Area (carts, desktops, tables, cabinets) clean, organized and uncluttered.

All sanitants/reagents properly labeled and within expiration date.

No trash on floor.

Room sanitation logbook available.

Other:

Equipment

Equipment calibrations within calibration due dates.

Equipment logbooks available.

Production/Process Controls

Appropriate room status tag posted on door.

Materials for different batches are segregated.

Other:

Records/Documentation

SOP binders available in room.

No uncontrolled documents in the room (post-it notes, calculations, scrap paper).

Logbooks (room, room changeover, equipment) filled out properly following cGMP's.

Other:

Safety

Floor and stairs free of slipping/tripping hazards.

Floor not wet or wet floor signs in place.

Eye wash station in good visible condition (weekly activation performed).

Fire extinguisher available and in good visible conditions (monthly inspection done).

Biohazard containers properly labeled (if not in use, lids in place).

Other:

Section II

Deficiency Description (provide as much detail as possible) - N/A table if no deficiencies.

Add Description

Room

Section Number

Deficiency Desciption

Please note that this checklist is a hypothetical example and provides basic information only. It is not intended to take the place of, among other things, workplace, health and safety advice; medical advice, diagnosis, or treatment; or other applicable laws. You should also seek your own professional advice to determine if the use of such checklist is permissible in your workplace or jurisdiction.