Can any one explain critical process parameters and its effects in injectables, stage wise(Componding-VIsual inspection)
How to Identify Critical Quality Attributes (CQA) and Critical Process Parameters (CPP)
Critical Quality Attributes (CQA)
– A physical, chemical, biological, or microbiological
property or characteristic that should be within an
appropriate limit, range, or distribution to ensure
the desired product quality (ICH Q8)
Approach to Identify CQAs
- Consider all DP quality attributes; physical attributes,
identification, assay, content uniformity, dissolution
and drug release, degradation products, residual
solvents, moisture, microbial limits, etc.
- Identify a CQA based on the severity of harm to a
patient (safety and efficacy) resulting from failure to
meet that quality attribute.
– Identified before taking into account risk control
– Does not change as a result of risk management
Critical Process Parameter (CPP)
– A process parameter whose variability has an impact on a
CQA and therefore should be monitored or controlled to
ensure the process produces the desired quality. (ICH Q8)
Critical Material Attribute (CMA)*
– A physical, chemical, biological or microbiological property
or characteristic of an input material that should be within
an appropriate limit, range, or distribution to ensure the
desired quality of output material.
*CMA is not defined in ICH guidance, but used here for discussion purposes.