Criticality Assessment- Identification of Critical Quality Attributes ...

Prior Knowledge & Risk Assessment
� Summarize all Prior Knowledge
– Include all sources of knowledge :Literature, patents, notes, company and
personal experience with projects.
– Knowledge from experience with (similar) prior projects with reference to
API, drug product, material properties of components, manufacturing
process, equipments, test methods, deviations, etc.
� Risk assessment (ICH Q9)
– Perform Initial risk assessment
– Ensure all forms of risk are acceptable
– Reduce potential variables to a manageable number.
– Limited risk assessments, important to prevent bias; systematic risk
analysis
– Should be clear, concise and current, basis for defining criticality.
� Prior knowledge and Risk assessment help in identifying the (knowledge
gaps) potential variables & prioritize them for further studies.
Pfizer • 13