Washroom iAudit (V1)

• Conducted on

  Date

• Auditor(s)

• Location
  Address

1.0 Documentation

• Are all applicable forms and documents available?

  Yes

  No

  N/A

• Has equipment been cleaned, sanitized & records/logs completed where applicable? <br>

  Yes

  No

  N/A

• Are Good Documentation Practices (GDP) followed for all<br>documents?

  Yes

  No

  N/A

• Are log books available and accurately completed to reflect<br>activity (usage, maintenance, and cleaning) of the equipment<br>and room / area, as needed?

  Yes

  No

  N/A

2.0 Good Manufacturing Practices (GMP)

• Is equipment in the area appropriately bagged and labeled?

  Yes

  No

  N/A

• Is the area clean, floor clear of debris or trip hazards?

  Yes

  No

  N/A

• Is the Equipment/Resource identified (Equipment ID,<br>Clean/Dirty/In-Progress) correctly and being used or stored<br>appropriately?

  Yes

  No

  N/A

• For OTC, is applicable validated equipment controlled as it should be?

  Yes

  No

  N/A

3.0 Washroom - General Area

• Is the area suitable for the designated operation?<br>(Appropriate lighting, exhibiting no leaks, no dust on filters,<br>clean and free of debris, etc.)

  Yes

  No

  N/A

• Are operations being performed within defined areas with the<br>necessary controls to prevent contamination or mix-ups?

  Yes

  No

  N/A

• Are all hoses, brushes, mops, and other tooling utilized for cleaning or repair properly stored when not in<br>use?

  Yes

  No

  N/A

• Does all relevant equipment have current calibration stickers<br>present?

  Yes

  No

  N/A

• Are floors, equipment, area walls /ceilings, outside containers<br>free of excessive dust, dirt and/or product residue?

  Yes

  No

  N/A

4.0 Gowning/Hygiene/Personal Protective Equipment (PPE)

• Are individuals wearing appropriate lab coats/uniforms, foot<br>wear, safety glasses, safety vest, etc. as required?

  Yes

  No

  N/A

• Are individuals wearing hair nets, beard nets (as applicable),<br>so that hair is not exposed?

  Yes

  No

  N/A

• Is the jewelry policy being adhered to so as not to cause a<br>safety/quality risk?

  Yes

  No

  N/A

• Is the area free of any evidence of food/beverages in the including gum, candy, bottles of soda, etc.?

  Yes

  No

  N/A

• Are individuals following good hygiene practices? (i.e. wearing<br>gloves, changing their gloves periodically, etc.)

  Yes

  No

  N/A

5.0 Data Integrity

• Are the login credentials being used to enter data in a given<br>system (SAP, etc) unique to the individual performing the data<br>entry?

  Yes

  No

  N/A

• Are GMP Personnel locking computers before walking away<br>from a GxP workstation to prevent unauthorized user access?

  Yes

  No

  N/A