Microbial data deviation investigations are notoriously difficult to perform. They are time-consuming and labor intensive. Determining the definitive root cause is often challenging. Evidence to support conclusions and decisions takes time to collect, and the available evidence is usually circumstantial and often scanty.
Developing a continuous manufacturing (CM) process for a new drug or implementing CM for an existing batch process demands significant time, effort, and money. Adapting any manufacturing process to CM requires in-depth chemical and mechanical engineering understanding as well as the right technologies.