Pink I’m a biotech production person and from my experience your statements are correct. FDA wants to see all those things. The products I have worked on for ind required a minimum of 3 batches and some companies do 5 now - what is called a process qualification (PQ). All batches are tested by quality assurance and released against preset criteria to show that they’re consistent and perform as described - you have to prove you can produce a product that is the same every time you make a batch to get an ind accepted. Hope that helps. I’m very excited about this tech I lost a few family members to cancer and one of my best friends is diabetic.
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