Appendix Files_ALL

4.4

Roles and Responsibilities

Role

Responsibilities

Owns the maintenance and updating of this SOP.

• • •

Facilities

Contract for all cleaning services. Owns the training on this SOP.

Perform disinfection at the defined frequency.

Cleaning Personnel • Area Management (or Designees) • •

Ensure that Procedure is reviewed and updated as necessary. Ensure support documentation is maintained. Ensure cleaning schedule requirements are met.

•

5.0 5.1

Procedure

DAILY

Step Action 5.1.1 Contracted cleaning service personnel will empty trash, take cardboard out to recycle bin, sweep, and mop floors down all aisles of GMP Warehouse Room 1400, and Shipping and Receiving Room 1401. 5.1.2 Document the cleaning of GMP warehouse Room 1400 and Shipping and Receiving Room 1401 in Room Log. 5.1.3 Wipe down plastic pallets brought in the warehouse for storage with 70% IPA prior to entry into the cGMP warehouse. 5.2 WEEKLY

Step Action 5.2.1 Sweep 2-8 °C Cold Room (1409) floors. Record cleaning in Room Log. 5.2.2 Sweep outside Loading Dock.

5.3

MONTHLY

Step Action 5.3.1 Mop cold room (1409) floors with 1:10 bleach and WFI solution. Record cleaning in Room Log . Ensure to record the material used for cleaning with lot number per Tagging Requirements for Manufacturing. Solution should be prepared on day of use. When mopping floors wear gloves and safety glasses.

5.4

QUARTERLY

Step

Action

5