Emerging technology: A key enabler for modernizing pharmaceutical manufacturing and advancing product quality.
Int J Pharm
; 509(1-2): 492-498, 2016 Jul 25.
Article
em En
| MEDLINE
| ID: mdl-27260134
ABSTRACT
Issues in product quality have produced recalls and caused drug shortages in United States (U.S.) in the past few years. These quality issues were often due to outdated manufacturing technologies and equipment as well as lack of an effective quality management system. To ensure consistent supply of safe, effective and high-quality drug products available to the patients, the U.S. Food and Drug Administration (FDA) supports modernizing pharmaceutical manufacturing for improvements in product quality. Specifically, five new initiatives are proposed here to achieve this goal. They include (i) advancing regulatory science for pharmaceutical manufacturing; (ii) establishing a public-private institute for pharmaceutical manufacturing innovation; (iii) creating incentives for investment in the technological upgrade of manufacturing processes and facilities; (iv) leveraging external expertise for regulatory quality assessment of emerging technologies; and (v) promoting the international harmonization of approaches for expediting the global adoption of emerging technologies.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Preparações Farmacêuticas
/
Tecnologia Farmacêutica
/
Indústria Farmacêutica
Limite:
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Int J Pharm
Ano de publicação:
2016
Tipo de documento:
Article