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American Pharmaceutical News In Review
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February 21, 2024
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   Unlocking Success for 503B Outsourcing Facilities

This article emphasizes the crucial role of robust Quality Management Systems (QMS) for compliance with Current Good Manufacturing Practices (cGMP). Examining FDA scrutiny of 503B facilities, the review highlights challenges and advocates for proactive measures. Strengthening QMS elements like the Quality Control Unit's independence, personnel training, and equipment validation is pivotal. Bridging the gap between compounding pharmacies and FDA-regulated facilities, the article urges a proactive approach to cGMP compliance.

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» Industry News
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  FDA Grants Orphan Drug Designation to Polycythemia Vera Treatment
Mabwell announced that FDA granted Orphan Drug Designation (ODD) to 9MW3011 (R&D code in the US: ... read more »
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  AbbVie Announces Appointment of Robert A. Michael as CEO
AbbVie announced that its board of directors has unanimously selected Robert A. Michael, AbbVie's ... read more »
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  Charles River and Wheeler Bio Complete Agreement to Accelerate the Journey from Discovery and CMC Development to Manufacturing
Charles River Laboratories International, Inc. announced a strategic agreement with Wheeler Bio, Inc... read more »
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  Biocytogen and Gilead Enter Into a Multi-Target Antibody Collaboration Agreement
Biocytogen Pharmaceuticals announced an antibody evaluation and option agreement with Gilead ... read more »

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» QC Corner
QC Corner
  QC Corner: Environmental Monitoring: Expert Discussion on the Benefits of a Single Incubation Temperature
The Environmental Monitoring program is an important quality control for the pharmaceutical ... read more »

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» Infographic
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  Eight Benefits of Switching to Digital Pharmaceutical Production
This infographic covers the reasons and benefits of transitioning from paper-based processes to a digital manufacturing production process. read more »
» Featured Articles
EVENT   Blended Natural Language Processing Solutions Combine Best of LLM and Deterministic Approaches to Improve Drug Development
The impressive abilities of general-purpose chatbots such as ChatGPT and Bard, powered by large language models (LLMs), to generate realistic text has... read more »
EVENT   Five Pharma Priorities for 2024: Setting a Realistic Regulatory and Quality Roadmap for the Year Ahead
The pharma industry continues to be in a state of flux. Merger and acquisition activity remains rife, new regulatory updates are being rolled out all ... read more »
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» Featured Video
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  On-Demand Webinar: Reducing Candidate Risk and Achieving Development Success with a Robust Developability Assessment Tool
In this on-demand webinar, we explore how DEVELOPICK™ systematically screens molecules, identifying candidates with the best potential for progression... watch »
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  On-Demand Webinar: Transforming Nanoparticles by Continuous Manufacturing
In this on-demand webinar: hear from Diant Pharma's CEO Antonio Costa, PhD as he discusses Transforming Nanoparticles by Continuous Manufacturing. watch »

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» Featured Products
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  Aclar® Crystal-clear Barrier Films
Honeywell Aclar® barrier films: committed to a safer and more sustainable future Aclar® is a clear, high-... learn more »
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  MiniCapt® Remote Microbial Air Sampler
Particle Measuring Systems Ideally suited for aseptic environments as part of a facility monitoring system, the MiniCapt® ... learn more »
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  VACUUBRAND® PC 3001 Vario® Select Vacuum Pump
BRANDTECH® Scientific The VACUUBRAND PC 3001 VARIO select is an ideal choice to support various steps in the extraction ... learn more »

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» Featured Whitepaper
EVENT   Guide: The Seven Most Asked Questions About Melting Point in the Pharmaceutical Industry
This guide from METTLER TOLEDO answers common questions related to the importance of melting point for pharmaceutical ingredients, the factors affecting melting point, USP requirements, and 21 CFR ... read more »
EVENT   Article: Making Automation the Standard: An Annex 1 Overview
The final version of the European Union (EU) good manufacturing practice (GMP) Annex 1 took effect in August 2023, advocating automated quality control (QC) technologies as a means of minimizing risk ... read more »

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» More Products
ACQUITY UPLC I-Class System Learn More
Climacell Incubators Learn More
BENCHTOP Manifold Freeze Dryer Learn More
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| Events
EVENT
  Excipient World Conference & Expo
Florida, USA –  05/13/2024
Excipient World is the only U.S. event focused exclusively on excipients. Join professionals from pharmaceutical, biologics, veterinary medicine, ... event details »
EVENT
  IFPAC-2024
Washington, D.C. –  03/03/2024
Join industry leaders, regulators, researchers, and solution providers from across the globe for in-depth discussions on the latest trends, ... event details »

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