Lessons from CDER’s Quality Management Maturity Pilot Programs

Between October 2020 and March 2022, FDA’s Center for Drug Evaluation and Research (CDER) completed two pilot programs to assess the quality management maturity (QMM) of drug manufacturing establishments. Mature quality systems promote proactive detection of vulnerabilities, prevent problems before...

Descripción completa

Detalles Bibliográficos
Autores principales: Maguire, Jennifer, Fisher, Adam, Harouaka, Djamila, Rakala, Nandini, Lundi, Carla, Yambot, Marcus, Viehmann, Alex, Stiber, Neil, Gonzalez, Kevin, Canida, Lyle, Buhse, Lucinda, Kopcha, Michael
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2023
Materias:
Commentary
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9831683/
https://www.ncbi.nlm.nih.gov/pubmed/36627496
http://dx.doi.org/10.1208/s12248-022-00777-z

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9831683/
https://www.ncbi.nlm.nih.gov/pubmed/36627496
http://dx.doi.org/10.1208/s12248-022-00777-z

Ejemplares similares