生命科学 eQMS 15 项

Contamination Control Strategy (CCS) Checklist (EU GMP Annex 1)

此检查清单为英文版。

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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