Biomedical Engineering Reference
In-Depth Information
Product quality
attribute
Product-related
substances
Impurities
Required testing
Product-related
impurities
Process-related
impurities
Host cell derived
and bioactive
medium
components
Medium
components
without biological
acitivity
Safety
assessment
Criticality determination
Testing plan
Figure
4.1. Product quality attribute risk management.
efficacy) and to evaluate the risk (severity and probability) for these attributes. This
process follows the question-based guidance outlined in ICH Guidance for Industry Q9
Quality Risk Management:
.
What might go wrong (attribute)?
.
What are the consequences (severity)?
.
What is the likelihood it will go wrong (probability)?
Figure 4.2 illustrates the outcome of the criticality determination for an attribute
identified as potentially affecting product quality. Risk is defined in ICH Q9 as the
product of the severity (consequences) and probability (likelihood of it going wrong).
Thus, the assessment of severity and probability as shown in Fig. 4.2 provides the
determination of criticality for an attribute.
Supporting information for this assessment includes prior product knowledge and
process capability. Prior product knowledge is the accumulated laboratory, nonclinical,
and clinical experiences for a specific product quality attribute. It may also include
