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36C25818Q0268 Attachment 8 Pharmaceutical Processing Rooms Semi Annual Checklist.docx

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Attachment #8 Semi-Annually Work Specifications Checklist

Pharmaceutical Processing Rooms

Note: CMMS-AMP-610 will be utilized and form CMMS FM- FG300 logbook will be used in this area to document cleaning.

Work to completed
Completed By
Date

1. Scrub and re-wax floors in Production zone floor hallway

3. Scrub and re-wax floor in Controlled Kit Assembly (RM188).

4. Scrub and re-wax floors in processing room (RM189).

7. 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.

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