Critical process parameters

[KMRAJU (K MANOHAR)]

Can any one explain critical process parameters and its effects in injectables, stage wise(Componding-VIsual inspection)

[sunilrbudhkar]

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

1. Consider all DP quality attributes; physical attributes,
   identification, assay, content uniformity, dissolution
   and drug release, degradation products, residual
   solvents, moisture, microbial limits, etc.
2. 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.