생명과학 eQMS 15개 항목
Contamination Control Strategy (CCS) Checklist (EU GMP Annex 1)
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Confirms that a holistic, documented Contamination Control Strategy links facility design, process, and controls to a defined understanding of microbial, particulate, and pyrogen risks. Use to build or assess an Annex 1 CCS.
EU GMP Annex 121 CFR 211ICH Q9
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CCS Framework
- Is a documented Contamination Control Strategy established across the facility and processes? *
- Does the CCS integrate the required elements (facility design, utilities, personnel, process, monitoring)? *
- Is the CCS underpinned by quality risk management principles? *
- Are roles and ownership for maintaining the CCS defined? *
Facility, Utilities, and Personnel
- Are cleanroom design, airflow, and pressure cascades defined to protect critical zones? *
- Are critical utilities (water, clean steam, compressed gases) controlled and monitored within the CCS? *
- Are personnel gowning, behavior, and access flows defined to minimize contamination risk? *
- Are barrier technologies (RABS/isolators) considered and justified?
Process and Monitoring Controls
- Are sterilization, disinfection, and bioburden controls defined and validated? *
- Is a science-based environmental and process monitoring program linked to the CCS? *
- Are alert and action limits defined and monitored with trending? *
- Are contamination sources and transfer routes mapped to controls in the CCS? *
Effectiveness and Lifecycle
- Is the CCS periodically reviewed for overall effectiveness using monitoring and event data? *
- Are contamination events and adverse trends fed back to update the CCS? *
- Is continuous improvement of controls demonstrated over time?
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