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eQMS para Ciências da Vida 15 itens

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

Este checklist está em inglês.

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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