According to the detailed analysis on process validation in ICH-Q7, in the product production process, it is proved that theproduction used for products meets theGMP requirements through systematic and documented evidence of process validation. And the process is stable and reliable,

Process validation process

Process validation documents: process report, method validation report, batch production record master, process validation scheme

Process validation batch generally includes 1 to 2 pre validation batches and 3 process validation batches

Accelerated and long-term stability tests can be conducted according to customer requirements