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February 16, 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 Approves First Medication to Treat Severe Frostbite
The FDA approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the ... read more »
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  Astellas and Kelonia Therapeutics to Develop Novel Immuno-Oncology Therapeutics
Astellas Pharma Inc. and Kelonia Therapeutics announced that Xyphos Biosciences, Inc., (a wholly ... read more »
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  Sibeprenlimab Receives FDA Breakthrough Therapy Designation for the Treatment of Immunoglobulin A Nephropathy
Otsuka Pharmaceutical Development & Commercialization, Inc., announced that the FDA granted ... read more »
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  Multiply Labs and Thermo Fisher Scientific Expand Cell Therapy Automation Partnership
Through integration with Multiply Labs' robotic technology, Thermo Fisher Scientific’s advanced, ... 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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  Pure Water in Drug Development: 5 Essentials to Ensure Quality
As pure water is such an essential part of the drug development process, here are five facts and recommendations to make sure pure water meets your ... read more »
» Featured Articles
EVENT   The Use of AI and ML in Biomanufacturing: Process and Product Validation Lifecycle and AI
The concept of continuous improvement is a philosophy of the industry and most pharmaceutical manufacturers as they strive to increase supply, gain ... read more »
EVENT   Embracing the Future: How In Vitro Assays Are Transforming Nonclinical Toxicology
Reliance on animal testing for drug development has long been a subject of ethical scrutiny and scientific debate. While the age-old practice ... 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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  Pharmafill TC3 Tablet Counter
Deitz Company The fully automated Pharmafill TC3 Tablet/Capsule Counter automatically counts tablets, capsules, ... learn more »
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  Polyplasdone™ Plus Multifunctional Disintegrant
Ashland Inc. Polyplasdone™ Plus multifunctional disintegrant is a direct compression superdisintegrant containing... learn more »
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  VIVACOAT® ocean-pure
JRS Pharma VIVACOAT® ocean pure uses chemically unmodified components allowing a label-friendly and natural ... learn more »

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» Featured Whitepaper
EVENT   Whitepaper: Automating the Endotoxin Testing Workflow
Pharmaceutical quality control (QC) testing labs face growing endotoxin testing demand and, consequently, relentless business pressure to enhance lab productivity. However, cumbersome and error-prone ... read more »
EVENT   Article: Establishing a Robust Quality System in a 503B Outsourcing Facility
The transition from being a sterile compounding pharmacy to an outsourcing facility is challenging. This review article is directed towards 503B outsourcing facilities strengthening their quality ... read more »

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» More Products
Adept 1 Analytical Isocratic High Pressure LC System Learn More
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DSC 204 HP Phoenix High-pressure Differential Scanning  Learn More
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| Events
EVENT
  INTERPHEX 2024
Javits Center, NYC –  04/16/2024
INTERPHEX returns to New York City on April 16-18, 2024. Register today and see for yourself why INTERPHEX is THE leading global event that takes you ... event details »
EVENT
  CPHI North America
Pennsylvania Convention Center –  05/07/2024
The growing US pharma event is back in Philadelphia for May 2024 Don’t miss out on turning connections into endless opportunity. Learn, innovate, and... event details »

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