약학회지
YAKHAK HOEJI
ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)

Table. 2.

Table. 2.

Element of CCS

No. Element Alternative
1 Design of both plant and process Design
2 Premises and equipment Premises/equipment
3 Personnel Personnel
4 Utilities Utilities
5 Raw material control - including in-process controls Raw material
6 Product containers and closures Container
7 Vendor approval - such as key component supplies, sterilization of components and single use system(SUS), and services Vendor
8 For outsourced services, such as sterilization, sufficient evidence should be provided to the contract giver to ensure the process is operating correctly Outsourcing
9 Process risk assessment PRM
10 Process validation PV
11 Preventative maintenance - maintaining equipment, utilities and premises (planned and unplanned maintenance) to a standard that will not add significant risk of contamination Preventative maintenance
12 Cleaning and disinfection. Cleaning
13 Monitoring systems - including an assessment of the feasibility of the introduction of scientifically sound, modern methods that optimize the detection of environmental contamination. Monitoring systems
14 Prevention – trending, investigation, corrective and preventive actions (CAPA), root cause determination and the need for more comprehensive investigational tools. CAPA
15 Continuous improvement based on information derived from the above. Continuous improvement
Yakhak Hoeji 2021;65:432-40 https://doi.org/10.17480/psk.2021.65.6.432
© 2021 Yakhak Hoeji