Search results for " pharmaceutical"
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Efforts Accelerate to Streamline Postapproval Change Process
And by encouraging greater reliance on pharmaceutical quality systems (PQSs) and change management protocols, policy makers hope to prevent drug shortages, while also reducing the time and cost involv…
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Managing Biomanufacturing Capacity Expectations
A 2007 article in Pharmaceutical Executive estimated that a launch delay costs an average of $15 million per drug per day (4). This number changes, however, depending on the market demand of the drug …
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GMP Challenges for Advanced Therapy Medicinal Products
Just how GMP problems for advanced medicines are sorted out in Europe could be a key influence over the future of personalized medicines and other new pharmaceutical technologies in the region.
The…
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Quality Systems Key to Lifecycle Drug Management
CDER’s new Office of Pharmaceutical Quality (OPQ) seeks to tackle these problems through more seamless integration of review, inspection, and surveillance throughout the product lifecycle, commented O…
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Quality by Design and Extractable and Leachable Testing
FDA Guidance for Industry, Q8 (R2) Pharmaceutical Development describes the elements of QbD used in pharmaceutical development (2). The guidance outlines a series of proactive steps used to build qual…
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Challenges and Trends in Biopharma Facility Design
Almhem (Modwave): Main drivers for modular design and construction in biopharmaceutical and pharmaceutical process facilities include breaking down the facility and the manufacturing processes into fu…
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Applying GMPs to the BioPharma Supply Chain
While tier 1 suppliers are largely reliable and aligned to needs of the pharmaceutical industry, there is a whole array of connected players that need to understand and adopt pharmaceutical best pract…
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Global Expansion Shapes Drug Oversight
Few FDA officials discuss pharmaceutical regulation these days without reference to how the international reach of the biopharmaceutical industry has altered drug research, production, and regulation.…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Both the Parenteral Drug Association (PDA) Technical Report 60 (7) and the International Society for Pharmaceutical Engineering (ISPE) Product Quality Lifecycle Initiative (PQLI) guide series (8-10) p…
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Drugs, At What Cost?
Specialty pharmaceuticals that treat complex, serious diseases will grow in importance in developed markets; traditional therapies will drive spending in emerging markets.
Biologics have a grow…