VALIDATION • SANITATION
Validation & Sanitation
The long-term operational quality of CPC is guaranteed by periodic validation and on-site verification work. We carry out everything from validation to sanitation in accordance with standardized procedures. We record the measurement and confirmation results on-site and support quality control through reports.
● Validation
Based on the Validation Master Plan, we perform documentation preparation and periodic implementation across the entire scope.
We maintain operating procedures, validation manuals, validation records, and repair logs for all manufacturing equipment, quality assurance analytical equipment, and air conditioning systems used in cell preparation facilities.
We systematize implementation plans and records according to the master plan, and continuously verify compliance with the Act on the Safety of Regenerative Medicine and GCTP ministerial ordinances.
Manufacturing Equipment
Air Conditioning Equipment
Environmental Monitoring
Analytical Instruments
Water for manufacturing
Documentation
● Sanitation
Operational rules for maintaining hygiene management
Sanitation is not a one-time task; it is operated by connecting daily wiping, periodic implementation, post-work confirmation, recording, and review.
The results of environmental monitoring are treated as judgment material for reviewing key management points and implementation frequency.
1. Scope, Agents, and Frequency
We define the scope, chemicals to be used, and the frequency of daily cleaning and periodic maintenance.
PLAN
2. Cleaning and Disinfection Work
We carry out work around equipment, floors, walls, and ceilings according to established procedures.
DO
3. Environmental Evaluation
We evaluate the environment after cleaning and disinfection.
CHECK
4. Documentation
We organize implementation records and evaluation results and store them as reports.
REPORT