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Quality Agreements: Making Them StickPharmaManufacturing.com
A good working relationship is critical to the success of any vendor quality agreement, but the right approach to drafting these contracts can make them far more effective.
Scaling Up and Controlling CrystallizationPharmaManufacturing.com
Process Tomography can offer insights into the onset of crystallization, allowing for improved process control.
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Visit our Editor's Blog: On Pharma
Our editors' blog, "On Pharma," goes behind consumer media headlines, beyond trade press boundaries, to offer candid analysis and commentary on issues affecting drug manufacturers. We cover the gamut, from fiscal to philosophical, from serious to silly. Reader responses are always welcome.
“PAT Talk”: The Pharma Quality Lifeline
Pharma Quality is being redefined by ICH, linking quality to process efficiency. Now it must carry the industry into the era of personalized medicine. Tune in to Emil Ciurczak and Jack Carroll for some straight talk on benchmarking and legacies from Deming et al.
Therapeutic Dose: Extending QbD to Stability Testing
The concept of a process signature can easily be extended to stability testing.
From the Editor: The Right Stuff
As it develops its quality systems and risk management strategies, pharma can learn a lot from military aviation
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News
- Trade Agency Wants To End Deals Delaying Generics Reuters.com
- Bristol-Myers to Sell ConvaTec Unit For $4.1 Bln Reuters.com
- Pfizer Invests $300 Mln in Irish Biotech Facility Reuters.com
- U.S. Lawmakers Seek More Foreign Drug Plant Checks Reuters.com
White Papers
Use of Universal HPLC Detection for Cleaning Validations
Several methods and traditional cleaning solvents for manufacturing devices spiked with typical drug substances and impurities were measured using HPLC-UV and CAD detection. HPLC with CAD provides a more complete view of the data since the CAD response has less solvent interferences and does not require the presence of chromophores for detection.
Overall Labor Effectiveness (OLE) Achieving a Highly Effective Workforce
Help your manufacturing business increase productivity and profitability through Overall Labor Effectiveness (OLE), a Kronos-developed key performance indicator that measures your workforce. As a companion to OEE (Overall Equipment Effectiveness), OLE gives your company the ability to analyze the impact of direct and indirect workforce output so that you can take action to reduce costs and to identify productivity opportunities.
Nanoparticles in Pharmaceutical Manufacturing
The paper explores the rapidly expanding role and significant performance advantages of nanoparticles in pharmaceutical applications. It provides an overview of nanoparticle uses in applications including diagnostic products, product packaging and biomarker discovery, as well as an extensive look at nanoparticle use in drug delivery. The paper also describes the ability to create nanoparticles efficiently and economically with media milling.
Has the Digital Dashboard Finally Arrived?
Advances in IT have made it easier than ever to develop dashboards that take supply chain data, in the form that’s needed, to those who need it most, whether they’re in production/operations or sales and marketing. Edge CSO Prest describes challenges and how to prevent data overload.