PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.
News|Articles|August 18, 2017
PTSM: Pharmaceutical Technology Sourcing and Management
- PTSM: Pharmaceutical Technology Sourcing and Management-09-06-2017
- Volume 12
- Issue 9
FDA Releases Supply Chain Guidance
Author(s)Pharmaceutical Technology Editors
The agency published guidance on identifying trading partners under DSCSA.
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On August 18, 2017, FDA published
DSCSA requires manufacturers, repackagers, wholesale distributors, and dispensers to meet certain requirements in order to be considered authorized trading partners. The guidance defines drug supply entities under DSCSA, what qualifies these entities as authorized partners, and outlines the licensure and reporting requirements for such entities, going into specifics on how to identify each type of partner in the supply chain.
Source:
Articles in this issue
about 9 years ago
Evolution of Analytical Tools Advances Pharma, But Challenges Remainabout 9 years ago
Reducing Risks Inherent with Cell-Culture Mediaabout 9 years ago
Managing Risk for Biomanufacturing Raw Materialsabout 9 years ago
Lonza Expands Capabilities for Drug Product Servicesabout 9 years ago
Corden Pharma Facility in Italy is Cleared by FDAabout 9 years ago
Cambrex Invests in Analytical Laboratory Expansionabout 9 years ago
Thermo Fisher Scientific Acquires Patheonabout 9 years ago
Swiss CDMO Expands GMP Manufacturing CapabilitiesAdvertisement
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