INSIGHTS ON QUALITY CONTROL
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Gene Therapy CDMO: Choosing The Right One
The global gene therapy market is continuing to grow, but knowledge and expertise for commercialization is still limited. Explore the benefits of partnering with a specialized gene therapy CDMO.
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Expert Approaches To Pharmaceutical Containment Design And Facility Integration
Review the process requirements, workflows, and process interventions that are key to your containment isolators achieving compliance with both cGMP and BSL-3.
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MAM Solutions For Process, Product Control Of Biotherapeutic Proteins
With industry-leading scientific expertise and customer support, we have pioneered solutions to some of the most pressing challenges facing customers interested in adopting MAM into their organizations.
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8 Ways Electronic Batch Record Software Boosts Efficiency In Pharmaceutical Manufacturing
Explore the eight key benefits of EBR Software and what makes this digital manufacturing solution superior to the traditional paper-based approach to managing critical documentation.
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Combat Major Cell And Gene Therapy Manufacturing Regulatory Obstacles8/8/2023
As cell and gene therapies grow in the pharmaceutical industry, drug sponsors must determine how to successfully navigate evolving regulations, study design considerations, and a lack of animal models.
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Bioburden And EU GMP Annex 1: Risk Assessment, Reduction, And Testing3/10/2023
Experts on regulation, filtration, sampling, and quality control discuss risk assessment and filtration-based strategies to reduce bioburden.
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Embracing GMP Manufacturing To Meet Pharma’s Future3/24/2023
As pharma companies aim to overcome development obstacles, it is important to incorporate GMP expertise alongside novel technologies that can enhance the properties of APIs and dosage forms.
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An Efficient And Reliable Way To Digitalize Your Sterility And QC Testing Data5/2/2023
Watch to learn about the M-Trace™ Electronic Test Record Software, your digital QC companion for trusted and efficient data recording that automizes and digitalizes your sterility and QC testing data.
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Pharmaceutical Quality Management Trends: Adopting Intelligent Solutions3/10/2023
Learn how to optimize pharma quality management data and design, themes to keep in mind when implementing AI, and ways to lay the foundation for AI solutions.
QUALITY CONTROL SOLUTIONS
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The United States Pharmacopeia USP 1207 guidance has been revised, encouraging the preference to deterministic, quantitative, and reliable non-destructive technologies to comply with quality standards.
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Advantech Sonic Sifter Powder Weighing and Transfer Enclosure designed to provide personnel protection during compacting and coating operations involving Highly Potent Active Pharmaceutical Ingredients (HPAPI).
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Traditional bioburden testing (or microbial limit testing) takes several days to grow visible colonies of microorganisms, so identifying these and initiating corrective action takes longer. The Milliflex® Quantum system quantitatively detects microbial contamination in filterable samples in as little as a third of the time it takes with traditional plate-based monitoring methods. The Milliflex® Quantum system is based on fluorescent staining of all viable microorganisms, making emerging microcolonies visible to the system when they’re still too small to be seen with the naked eye. After rapid detection, the colonies can be reincubated to grow into visible colonies and be identified by any method—an approach that cleverly combines rapid and compendial bioburden testing.
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Waters is providing a pathway for easier access to our latest innovative technologies with our FlexUP Technology Renewal Program.
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Discover a 21 CFR Part 11-compliant digital validation platform designed for conducting IQ & OQ on your microbial QC testing systems dedicated to bioburden testing, sterility testing, and air monitoring.