YAKHAK HOEJI

Table. 3. Table 3

Data criticality for product quality and safety

Rating	Description	Score
Critical	▪ The intended use of the data directly impacts product quality and/or product safety ▪ Decision on batch release (e.g. results of release test) ▪ Critical quality attribute (CQA), critical process parameter (CPP), and key parameters	10
Major	▪ Quality attributes or process parameters that may not be directly linked to CQA/CPP/key parameters ▪ Decisions on pass or fail of cleaned, sanitized or sterilized operational condition ▪ Monitoring, maintaining and controlling environment conditions of GMP area including microbial and clean utility monitoring	5
Minor	▪ The intended use of the data is to provide evidence of GMP compliance relating to monitoring and control of processes that not falling within“Critical”or“Major”	1