The US Food and Drug Administration (FDA) has issued draft guidance to assist manufacturers in complying with its good manufacturing practice (GMP) regulations under 21 CFR 211.110 governing batch uniformity for drug and biological products. The guidance specifically addresses methods for ensuring blend uniformity for products made through advanced manufacturing techniques, such as continuous manufacturing and 3D printing.
The guidance recommends the use of process models combined with in-process material testing to ensure the blend uniformity of drug products produced on a continuous manufacturing line.
Until this point, there has been limited FDA guidance on how manufacturers can assess blend uniformity for products that are made on a continuous manufacturing line or 3D printed…
