"Upon first reading this draft guidance, it doesn’t seem to be telling us anything we don’t already know," says Steven Erb, Crown Point Biotech Consulting LLC. But then he does an admirable job of telling us what we know, and need to confirm. We are talking here about FDA draft guidance “Considerations for Complying with 21 CFR 211.110,” released in January. https://lnkd.in/egCefxD9
GMP Consultant
1wGreat article.