USA – Batch uniformity: FDA details testing approaches for continuous manufacturing, 3D printing

Fiche du document

Date

25 mars 2025

Discipline
Types de document
Périmètre
Identifiants
Source

ELSIBI

Collection

Hypothèses : carnets de recherches en Sciences humaines et sociales

Organisation

OpenEdition

Licence

info:eu-repo/semantics/openAccess

Sujets proches En

3DP (Three-dimensional printing) 3-D printing 3D printing

Citer ce document

« USA – Batch uniformity: FDA details testing approaches for continuous manufacturing, 3D printing », ELSIBI, ID : 10.58079/13kgf

Métriques

Partage / Export

Résumé 0

The US Food and Drug Administration (FDA) has issued draft guidance to assist manufacturers in complying with its good manufacturing practice (GMP) regulations under 21 CFR 211.110 governing batch uniformity for drug and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-pr...

document thumbnail

Sur les mêmes sujets

Sur les mêmes disciplines