[1] The purpose of process validation is to ensure varied inputs lead to consistent and high quality outputs.
Input variables are isolated in order to identify the root cause of potential quality issues and the manufacturing process is adapted accordingly.
PAT facilitates measurement of quantitative production variables in real time and allows access to relevant manufacturing feedback.
[7] Historical data can also help manufacturers better understand operational process and input variables as well as better identify true deviations from quality standards compared to false positives.
Should a serious product quality issue arise, historical data would be essential in identifying the sources of errors and implementing corrective measures.
Deviations from prescribed output methods and final product irregularities are flagged by a process analytics database system.
Continuous process verification analyses critical process parameters and critical quality attributes in real time to confirm production remains within acceptable levels and meets standards set by ICH Q8, Pharmaceutical Quality Systems, and Good manufacturing practice.