As per new guidlines of us fda, every product not
only need to validate but also need to verify this
process contineusly for consistant quality product
manufacturing.
But we varify the all parameter of manufacturing
all batch by APQR “anual product quality review”.
This is also continues varification method, there
is any other way to explain we regularly check and
verify the parameter? ?
How can we explain this?
regards,
Abhijeet
You posted excellent question.
Most of the data is present in APQR. This was relatively old concept.
After the implementation of a strong QbD programme, one can find out each and every parameter that is responsible to effect the Critical Quality of a Drug Substance and or a Drug product.
These critical parameters are decided and deciphered by using ICH guidance tools like Q5 documents and Q9 (QRM) tools and also each and every data is written as per the Q10 (Quality Management system or Pharmaceutical Quality System (Eu) ).
Continuous process verification will keep a product in a state of control.
A state of control is only obtained when a manufacturing process and its Quality testing procedures are with in set point ranges that were obtained by proper development programme (Stage-1 fda guidance) and (Stage -2 PPQ).
Both terminology and ways to present the data were changed.