Appendix Files_ALL

Facilities (FA)

Coordinate work inside the clean rooms with MFG. Collect, analyze, and report environmental sampling

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results. •

QC Microbiology

Coordinate with MFG to implement controls

associated with room status changes.

• QA reviews documentation associated with this procedure, audits to ensure compliance with this procedure, and archives documentation associated with this procedure.

QA

5.0 Procedure 5.1 General Information

Step Action 5.1.1 P ERFORM disinfection activities per Appendices 2 through 4. • Cleaning personnel are to perform disinfection activities of vertical surfaces, horizontal surfaces, floors, and miscellaneous surfaces such as bins, cabinets, gowning material racks, etc. PERFORM event response disinfection activities per Appendix 4. • Manufacturing personnel are to perform disinfection activities of process equipment and surfaces. PERFORM event response disinfection activities per Appendix 4. NOTE: The cleaning levels are designed to provide escalating decontamination. The highest level of cleaning due will supersede lower levels. For example, when the Monthly cleaning (Level 3) is due and being performed, the Daily cleaning (Level 1) does not need to be performed in addition that day. 5.1.2 ENSURE that TRAFFIC is limited to those that are performing disinfection activities in those areas. ENSURE that gowning and disinfection do not occur at the same time (Grade C/D airlocks). 5.1.3 AVOID circular or scrubbing motions. 5.1.4 LABEL all BUCKETS and mops with their dedicated cleaning zones. 5.1.5 PERFORM Grade C/D disinfection using the triple bucket system. PERFORM area DISINFECTION per the zone sequence in the table below: IF… THEN Clean in the following sequence

Performing routine or non-routine cleaning Performing event response disinfection

Zones in any order per the room sequence and personnel flow defined in Appendix 1 Perform cleaning from higher grade to lower grade for zone(s) listed below.

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