Lonza GMP Cleaning Inspection - Building 228, Manufacturing Areas

Audit Information

• Client Name;

• Conducted on;

  Date

• PSS Management Representative

  Select Mike Garrett Sean Garrett Veronica Moisa Alan Garrett Dave Sherrington Graham Cunningham Daniel Kirkbride

  • Mike Garrett
  • Sean Garrett
  • Veronica Moisa
  • Alan Garrett
  • Dave Sherrington
  • Graham Cunningham
  • Daniel Kirkbride

• PSS Supervisor Present During Audit

  Yes

  No

• Client Representative Present During Audit

  Yes

  No

• Document No.

Female Changing Areas

• FLOORING -Is the 4 stage Biocide Clean being carried out 2 days per week?

  Yes

  No

  N/A

• FLOORING - Is the 2 stage Biocide clean being carried out 5 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 4 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 2 stage Biocide clean being carried out 2 days per week?

  Yes

  No

  N/A

• DRAINS - Is the 2 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• SINKS - Is the 2 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

Male Changing Areas

• FLOORING -Is the 4 stage Biocide Clean being carried out 2 days per week?

  Yes

  No

  N/A

• FLOORING - Is the 2 stage Biocide clean being carried out 5 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 4 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 2 stage Biocide clean being carried out 2 days per week?

  Yes

  No

  N/A

• DRAINS - Is the 2 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• SINKS - Is the 2 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

Ground Floor Corridors

• FLOORING -Is the 4 stage Biocide Clean being carried out 2 days per week?

  Yes

  No

  N/A

• FLOORING - Is the 2 stage Biocide clean being carried out 5 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 4 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 2 stage Biocide clean being carried out 2 days per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

Buffer Hold / Buffer Change and Transfer Areas

• FLOORING -Is the 4 stage Biocide Clean being carried out 2 days per week?

  Yes

  No

  N/A

• FLOORING - Is the 2 stage Biocide clean being carried out 5 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 4 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 2 stage Biocide clean being carried out 2 days per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

Buffer Prep

• FLOORING - Is the 2 stage Biocide clean being carried out 7 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 2 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

EFH / Facility B Change Areas and Interlocks

• FLOORING -Is the 4 stage Biocide Clean being carried out 2 days per week?

  Yes

  No

  N/A

• FLOORING - Is the 2 stage Biocide clean being carried out 5 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 4 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 2 stage Biocide clean being carried out 2 days per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

EFH / Facility B

• FLOORING -Is the 4 stage Biocide Clean being carried out 1 day per week?

  Yes

  No

  N/A

• FLOORING - Is the 2 stage Biocide clean being carried out 6 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 2 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• DRAINS - Is the 2 stage Biocide clean being carried out 7 days per week?

  Yes

  No

  N/A

• SINKS - Is the 1 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

SWFH Change Areas

• FLOORING -Is the 4 stage Biocide Clean being carried out 2 days per week?

  Yes

  No

  N/A

• FLOORING - Is the 2 stage Biocide clean being carried out 5 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 4 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 2 stage Biocide clean being carried out 2 days per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

SWFH

• FLOORING -Is the 4 stage Biocide Clean being carried out 1 day per week?

  Yes

  No

  N/A

• FLOORING - Is the 2 stage Biocide clean being carried out 6 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 2 stage Biocide clean being carried out 1day per week?

  Yes

  No

  N/A

• DRAINS - Is the 1 stage Biocide clean being carried out 7 days per week?

  Yes

  No

  N/A

• SINKS - Is the 1 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

NWFH (All rooms)

• FLOORING -Is the 4 stage Biocide Clean being carried out 1 day per week?

  Yes

  No

  N/A

• FLOORING - Is the 2 stage Biocide clean being carried out 6 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 2 stage Biocide clean being carried out 1day per week?

  Yes

  No

  N/A

• DRAINS - Is the 1 stage Biocide clean being carried out 7 days per week?

  Yes

  No

  N/A

• SINKS - Is the 1 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

Purification Change Areas / Interlocks and Corridors

• FLOORING -Is the 4 stage Biocide Clean being carried out 2 days per week?

  Yes

  No

  N/A

• FLOORING - Is the 2 stage Biocide clean being carried out 5 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 4 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 2 stage Biocide clean being carried out 2 days per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

Suites 1 / 2 / 3

• FLOORING - Is the 2 stage Biocide clean being carried out 7 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 2 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• DRAINS - Is the 2 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• SINKS - Is the 2 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

Purification (+5) Cold Rooms

• FLOORING - Is the 2 stage Biocide clean being carried out 7 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 1 stage Biocide clean being carried out Once a Month?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

Consumable Store

• FLOORING -Is the 4 stage Biocide Clean being carried out 2 days per week?

  Yes

  No

  N/A

• FLOORING - Is the 2 stage Biocide clean being carried out 5 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 4 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 2 stage Biocide clean being carried out 2 days per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

Bulk Fill Prep Areas

• FLOORING - Is the 2 stage Biocide clean being carried out 7 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 1 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

Bulk Fill Cold Areas

• FLOORING - Is the 1 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 1 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

Bulk Fill Change and Transfer Areas

• FLOORING - Is the 2 stage Biocide clean being carried out 7 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 2 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

Bulk Fill

• CAMPAIGN - Is the 1 stage Biocide clean taking place 1 day per week or between every product batch?

  Yes

  No

  N/A

• FLOORING - Is the 1 stage Biocide clean taking place 1 day per week or between every product batch?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 1 stage Biocide clean being carried out on each day of area use?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

Facility E Transfer and Change Rooms

• FLOORING -Is the 4 stage Biocide Clean being carried out 2 days per week?

  Yes

  No

  N/A

• FLOORING - Is the 2 stage Biocide clean being carried out 5 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 4 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 2 stage Biocide clean being carried out 2 days per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

Facility E

• FLOORING - Is the 2 stage Biocide clean being carried out 7 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 2 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• DRAINS - Is the 2 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• SINKS - Is the 2 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

West Staircase

• FLOORING -Is the 4 stage Biocide Clean being carried out 2 days per week?

  Yes

  No

  N/A

• FLOORING - Is the 2 stage Biocide clean being carried out 5 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 4 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 2 stage Biocide clean being carried out 2 days per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

First Floor Corridor

• FLOORING -Is the 4 stage Biocide Clean being carried out 2 days per week?

  Yes

  No

  N/A

• FLOORING - Is the 2 stage Biocide clean being carried out 5 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 4 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 2 stage Biocide clean being carried out 2 days per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

Cleaning Storage Areas

• FLOORING -Is the 4 stage Biocide Clean being carried out 2 days per week?

  Yes

  No

  N/A

• FLOORING - Is the 2 stage Biocide clean being carried out 5 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 4 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 2 stage Biocide clean being carried out 2 days per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

MST Areas

• FLOORING -Is the 4 stage Biocide Clean being carried out 1 day per week?

  Yes

  No

  N/A

• FLOORING - Is the 2 stage Biocide clean being carried out 6 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 2 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• DRAINS - Is the 2 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• SINKS - Is the 1 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

Autoclave Loading Room

• FLOORING - Is the 2 stage Biocide clean being carried out 7 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 2 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

Wave Area, Inoculum Change and Transfer Areas

• FLOORING -Is the 4 stage Biocide Clean being carried out 2 days per week?

  Yes

  No

  N/A

• FLOORING - Is the 2 stage Biocide clean being carried out 5 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 4 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 2 stage Biocide clean being carried out 2 days per week?

  Yes

  No

  N/A

• SINKS - Is the 1 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

Inoculum Suites and Media Prep

• FLOORING - Is the 2 stage Biocide clean being carried out 7 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 2 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• SINKS - Is the 1 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

Consumable Store & QC Equip Room

• FLOORING -Is the 4 stage Biocide Clean being carried out 2 days per week?

  Yes

  No

  N/A

• FLOORING - Is the 2 stage Biocide clean being carried out 5 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 4 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 2 stage Biocide clean being carried out 2 days per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

Dispensary (+5C) Cold Rooms

• FLOORING - Is the 1 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 1 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

• FLOORING - Is the Once a Month Sweep/Vacuum and Sanitise with Klercide 70/30 taking place?

  Yes

  No

  N/A

Dispensary (-20C) Cold Rooms

• FLOORING - Is the Once a Month Sweep/Vacuum and Sanitise with Klercide 70/30 taking place?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 1 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

Cell Banking Change Area /Interlock Rooms

• FLOORING -Is the 4 stage Biocide Clean being carried out 2 days per week?

  Yes

  No

  N/A

• FLOORING - Is the 2 stage Biocide clean being carried out 5 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 4 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 2 stage Biocide clean being carried out 2 days per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

Cell Banking Dewar, QA Office and Lobby Areas

• FLOORING -Is the 4 stage Biocide Clean being carried out 2 days per week?

  Yes

  No

  N/A

• FLOORING - Is the 2 stage Biocide clean being carried out 5 days per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 4 stage Biocide clean being carried out 1 day per week?

  Yes

  No

  N/A

• SURFACES / DOORS - Is the 2 stage Biocide clean being carried out 2 days per week?

  Yes

  No

  N/A

• Take photo of current page of Log Book for this area.

  Media

Other Areas (please list)

• Add question?

  Yes

  No

  N/A

• Is the Cleaning Equipment clean and tidy throughout the Manufacturing Area?

  Yes

  No

  N/A

• Take photo of last entry of the cleaning machine Log Books

  Media

• Are all PSS Staff wearing the correct PPE for the areas in question?

  Yes

  No

  N/A

• Have stock levels been audited, are there sufficient on site?

  Yes

  No

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• Premium Representative Sign Off

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• Client Representative Sign Off

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