This document discusses terminal sterilization qualification and risk assessment for parenteral drug manufacturing facilities. It provides a model for calculating risk as a combination of the probability and severity of potential harms. The model uses a risk priority number to evaluate different processes and parameters within raw material handling, filling operations, sterilization, and other areas. The goal is to identify high risks and ways to reduce risks through controls and continual improvement.
8. 8
Severity
Probability
Frequent Likely Occasional Not often Unlikely
Catastrophic E E H H M
Critical E H H M L
Marginal H M M L L
Negligible M L L L L
E – Extremely high risk H – High risk M – Moderate risk L – Low risk
12. Total S X P X D = RPN
Severity
Probability
Detectability
E (4) H (3) M (2) L (1)
E (4) H (3) M (2) L (1)
E (1) H (2) M (3) L (4)
S
P
D
33 - 48 01 - 1649 - 64 17 - 32
E H M L
25. High LowExtremely High Moderate
E H M L
Unidirectional air flow above and/ or at
critical locations (e.g. turntables,
interventions..) or not (turbulences or
shadowing)
26. Non-viable particulate count
High LowExtremely High Moderate
E H M L
Clean room
parameters
appropriate
Pressure
Air Exchange Rate
Humidity
Temperature
80. Preventing error
is more important than
finding rejects because it
is not always possible to
detect 100% quality
defects
SCIENCE
is always the best answer
81. Quality must be designed
into the process and
cannot be achieved
only by testing
Testing is not the answer