Drug Product Manufacturers may produce placebo product during the PQ-phase to demonstrate the process and equipment are functioning prior to manufacturing commercial product. What is expected in performing a PQ in an API facility?

It may be difficult to run a “placebo” batch in API processes. Many companies may run solvents
or a water batch to simulate the API process. In other instances, a company may go directly to a
validation phase after IQ/OQ, without the benefit of a true PQ.