Search results for " pharmaceutical" in Articles / App Notes
Article
Modular Manufacturing Platforms for Biologics
While the idea of modular construction has been used in other industries for decades, it has only started gaining traction for pharmaceutical applications during the past 20–30 years.
Modular syst…
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Brazil Emerges as Global Biopharm Collaborator
The pharmaceutical market in Brazil has been growing steadily and strongly in the past five years. The country is eying production and innovation, relying on the key support of the government. Accordi…
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FDA Seeks Metrics to Define Drug Quality
…nufacturing problems may precipitate plant closings and product discontinuations and what strategies pharmaceutical companies use to track and prevent such failures. Most obvious are reports of compa…
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Real Time Continuous Microbiological Monitoring
…a Agar or Casein Soya Bean Digest agar, constitutes a common practice in the microbial monitoring of pharmaceutical environments. The results are obtained after enough days of incubation allow the de…
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Design and Qualification of Single-Use Systems
International Council for Harmonization (ICH) Q7, European Medicines Agency (EMA) Q7, and FDA
Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients incorporate essentially…
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Framing Biopharma Success in 2016
…g manufacturers; to improve its ability to predict and mitigate drug shortages; and “encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pha…
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FDA Releases Draft Guidance on Emerging Manufacturing Technology
23, 2015, FDA released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base. The guidance discusses the inclusion of a new FDA progr…
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Modern Manufacturing Systems Key to FDA Quality Initiative
CDER’s new Office of Pharmaceutical Quality (OPQ), led by CDER director Janet Woodcock, is establishing systems to identify high-risk, problematic facilities and products—and those operations that rel…
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Bioburden Control in the Biopharmaceutical Industry
According to FDA’s definition, an “adulterated” pharmaceutical product is one which is manufactured under non-cGMP conditions. Even if the product itself meets specifications, it is still considered “…
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Continuous Manufacturing: A Changing Processing Paradigm
GlaxoSmithKline, Johnson & Johnson, Genzyme, Bristol-Myers Squibb, AstraZeneca, Samsung BioLogics, and Novartis AG are among the pharmaceutical companies and contract organizations building or expandi…