Displaying 1–7 of 7 results for Ali Afnan, Principal, StepChange Pharma
FDAs Office of Product Quality needs a change agent. Ali Afnan has a suggestion.
Why are we so comfortable following draft guidanceFDAs unfinished and incomplete current thinking?
Effective change must improve business performance, and not just a process.
Process knowledge demands a very different approach to sampling.
FDAs new guidance on process validation gets back to the original language of the GMPs on the subjects of control and sampling, Ali Afnan writes. After all, FDA never intended for three consecutive batches to satisfy either the spirit or the letter of the law.
New paradigms are needed if PATs promise is to be realized for biopharma process control.