36C25818Q0268-003.docx

Attachment #2 Daily Work Specifications Checklist Pharmaceutical Processing Rooms and BPLS laboratory and Specimen Storage areas:

Note: CMMS-AMP-610 will be utilized and form CMMS FM- FG300 logbook will be used in manufacturing and primary packaging area

Date T Date W Date T Date F Date

1. There will be no dust mopping permitted in the Production Zone areas, vacuuming only.

2. All Production Zone rooms, hallway and Janitorial Room will be vacuumed and sanitized with approved disinfectant utilizing disposable clean room type mop head.

3. Empty all trash containers in Production Zone.

4. Empty trash containers in BPLS Laboratory.

5. Remove garbage from the facility and place in dumpster

6. Production, Processing and Storage Rooms #’s 174, 175, 176, 177, 178, 179, 180, 181, 186, 309, 310 and 311 (During production periods only by COR request):

a. Vacuum and damp mop with approved clean room disposable mop head after production process has been completed.

b. Clean walls, doors, sinks, ceiling horizontal and vertical surfaces, furniture, adjoining hallways, and light fixtures to prevent cross contamination in compliance with current Good Manufacturing Practices (cGMP’s) specifically 21 CFR Section 211.56. Cleaning standards shall meet class 7 standards provided by ISO 14644-1 /7 class 10,000 and any written procedural documentation provided by CSP.

7. Production Zone janitorial closet is kept clean and neat at all times including janitorial sink.

8. Empty all trash receptacles in Clinical Kit Assembly (RM 187).

9. Empty trash from all Processing rooms.

10. Vacuum and damp mop with disposable clean room type mop head Production Zone Pharmaceutical Grade Equipment washing room (During production periods only by COR request).

11. Wipe down and clean processing tables that are void of drugs or devices and cubicle dividers in Room #187 Clinical Kit Assembly with approved cleaner. Special requests can be made by the COR on an as needed basis. VA staff will clear table surfaces prior to cleaning