QA PIP GMP Walkthrough Form

• Audit Title

• Lead Inspector:

• Inspectors:

• Conducted on

  Date

• Area

• Rooms

• Area Supervisor (If Accompanied):

• 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).<br>

  Deficiency (Details Section II)

  No Deficiency (N/A)

• Employees wearing appropriate PPE (if applicable).

  Deficiency (Details Section II)

  No Deficiency (N/A)

• Other:

Room

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

  Deficiency (Details Section II)

  No Deficiency (N/A)

• All ceiling lights operational.

  Deficiency (Details Section II)

  No Deficiency (N/A)

• All insulation free of cracks.

  Deficiency (Details Section II)

  No Deficiency (N/A)

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

  Deficiency (Details Section II)

  No Deficiency (N/A)

• All sanitants/reagents properly labeled and within expiration date.

  Deficiency (Details Section II)

  No Deficiency (N/A)

• No trash on floor.

  Deficiency (Details Section II)

  No Deficiency (N/A)

• Room sanitation logbook available.

  Deficiency (Details Section II)

  No Deficiency (N/A)

• Other:

Equipment

• Equipment calibrations within calibration due dates.

  Deficiency (Details Section II)

  No Deficiency (N/A)

• Equipment logbooks available.

  Deficiency (Details Section II)

  No Deficiency (N/A)

Production/Process Controls

• Appropriate room status tag posted on door.

  Deficiency (Details Section II)

  No Deficiency (N/A)

• Materials for different batches are segregated.

  Deficiency (Details Section II)

  No Deficiency (N/A)

• Other:

Records/Documentation

• SOP binders available in room.

  Deficiency (Details Section II)

  No Deficiency (N/A)

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

  Deficiency (Details Section II)

  No Deficiency (N/A)

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

  Deficiency (Details Section II)

  No Deficiency (N/A)

• Other:

Safety

• Floor and stairs free of slipping/tripping hazards.

  Deficiency (Details Section II)

  No Deficiency (N/A)

• Floor not wet or wet floor signs in place.

  Deficiency (Details Section II)

  No Deficiency (N/A)

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

  Deficiency (Details Section II)

  No Deficiency (N/A)

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

  Deficiency (Details Section II)

  No Deficiency (N/A)

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

  Deficiency (Details Section II)

  No Deficiency (N/A)

• Other:

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

Add Description

• Room

• Section Number

• Deficiency Desciption