Pharmaceutical Technology - Pharmaceutical Manufacturing & Development News & Research for Scientists

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PharmTech Europe

QbD in API Manufacturing
With a quality-by-design approach, robust processes consistently can help deliver quality product.
A Practical Approach of Implementing GMP for Excipients
Using a model quality risk-management process according to ICH Q9, the authors discuss ways to apply this guideline.
Meeting the Challenges of Excipient Variability
The quality and composition of excipients can vary due to environmental factors, processing methods, raw material quality, manufacturing location changes, and even operator actions.
Minimizing Variation in Vial Withdrawal Practice
Innovations in drug delivery such as needle-free transfer devices and vial adapters can provide consistency when transferring liquid for reconstitution of lyophilized drug products.
Asymmetric Synthesis Continues to Advance
A survey of the recent literature reveals numerous advances in asymmetric chemocatalysis.
Modularity Creates Flexible Manufacturing Systems
Flexibility, which involves the ability to quickly change product capacity or even product type to meet market demand, is increasingly important. In new construction or renovation, modular process skids and modular buildings create this flexibility. Experts discuss trends and challenges.
PharmTech eBook Series
Bioprocessing and Sterile Manufacturing
Review emerging trends in the development and manufacturing of parenteral and biologic drugs, including continuous manufacturing, monitoring, sterilization procedures, modular manufacturing, and single-use technologies.
Solid Dosage and Excipients
Review emerging trends in the formulation and manufacture of solid dosage drugs, as well as the role of excipients in enhancing the functionality of these drug forms.

Expert Interviews, Industry Trends, and more

USP Supply Chain Safety Videos
Peer-Reviewed Articles
Investigation of Various Impurities in Febuxostat
Comparing Manufacturing Process Options
Cleanability of Pharmaceutical Soils from Different Materials of Construction
Achieving Zero-Order Release Kinetics Using Multi-Step Diffusion-Based Drug Delivery
Through-Vial Impedance Spectroscopy: A New In-Line Process Analytical Technology for Freeze Drying
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From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
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Industry Leaders: Q+A
Q&A with Paul Nelles, Vetter Development Service
Paul Nelles of Vetter Development Service discusses prefilled syringes.

PharmTech Europe 25th Anniversary
Tracking the Pulse of the Pharmaceutical Industry
Pharmaceutical Technology Europe marks its 25th anniversary.
Standards & Regulations
European Commission Approves RoACTEMRA for Treatment of RA
Roche?s RoACTEMRA receives EU approval for use in patients with early rheumatoid arthritis.
Data Integrity Key to GMP Compliance
FDA demands accurate manufacturing and test information to ensure product quality.
Extending the Scope of Pharmacovigilance Comes at a Price
As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.
A Case for an FDA Dean's List
FDA is moving in the right direction in terms of implementing stratification by levels of compliance across pharmaceutical manufacturing sites. However, quality is a matter of culture more than metrics. In this opinion article, the author presents arguments for an FDA Dean's List as a means to nurture a quality culture within the industry.
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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