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Tech Talk: CHANGING GMP BEHAVIORS with NSF
| By NSF Health Sciences Pharma Biotech PBR
Most people are content sticking with what they know and their tried and tested habits. It’s easy. To get people to think and act differently (a painful process for most), you have to provide them with the motivation.
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FlexyCUBE Product Catalog
| By SYSTAG
SYSTAG - Your Partner in Chemical Development
Automation > Laboratory Instrumentation > White Papers
Malvern Instruments: Exploring the impact of particle characteristics on suspension rheology
| By Malvern Instruments
How particle size, shape and zeta potential influence suspension rheology. Many products are suspensions or dispersions of particles in a liquid medium. Examples range from adhesives, ceramics, paints and inks through to foods, drinks, personal care products and medicines. The physical properties of the dispersed particles in such systems, including particle size, particle size distribution, concentration, electric charge (zeta potential), and even particle shape, can all strongly influence the overall (bulk) rheological properties of a suspension, thereby defining product behavior and functionality. Understanding these interactions is crucial when it comes to achieving desirable product performance, whether it be a stable paint or medicine, workable cement, or a visually appealing shower gel or drink. This white paper examines the impact of particle properties on suspension viscosity, and more broadly on rheological behavior. It looks in some detail at how particle size, shape and zeta potential influence critical aspects of suspension performance such as viscosity and stability and how these properties can be manipulated to tailor this behavior.
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The new MicroCal PEAQ-DSC Automated System
| By Malvern Instruments
Eight reasons to upgrade from the MicroCal VP-Capillary DSC system. Use of Differential Scanning Calorimetry (DSC) in biopharmaceutical development. Differential scanning calorimetry (DSC) is an established biophysical tool for protein stability characterization during biopharmaceutical drug development. DSC data are used to advance the most stable and 'developable' proteins into the pipeline, and optimize the process and formulation conditions to maintain protein stability during manufacturing and storage.
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NSF: KPIs and the Head of Corporate Quality: KPIs Are Essential for a Successful Product Release
| By NSF Health Sciences Pharma Biotech PBR
What are your views on KPIs? Essential or a necessary evil? “They are absolutely essential, providing they are good! I remember during a regulatory inspection I was asked every QP’s most feared question: How do you know everything is in control before you release product?
White Papers
NSF: Learn from a Fabulously Successful GMP Remediation Program
| By NSF Health Sciences Pharma Biotech PBR
This White Paper describes a remediation program that appeared at first to be impossibly daunting, expensive and unattainable. The company had received a range of critical and major GMP deficiencies from the UK regulatory body, MHRA, and was facing a referral to MHRA’s Inspection Action Group. Manufacturing had to be suspended pending a risk assessment of the non-compliances; evaluating the effect of the non-compliances in terms of risks of misbranding and adulteration of the products. Shifts were cancelled, the supply chain was suspended and an urgent remediation program begun.
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NSF: Remediation of Pharma Quality Systems – It’s All About the People
| By NSF Health Sciences Pharma Biotech PBR
Much of NSF Pharma Biotech Consulting’s work involves helping companies remediate flawed quality systems. This is usually done as a result of threatened or actual enforcement action by regulatory agencies. In these circumstances, companies are desperate and willing to do ‘whatever it takes’ without a full understanding of what that means. While expansive in concept, ‘whatever it takes,’ for many, means simply deploying internal and external resources to design and document a new quality management system. This is a significant commitment by management in resources, but unless the cause (how did this happen?) is also considered, the effort is doomed to fail.
White Papers
Brexit Implications for UK Pharmaceutical Administration with NSF
| By NSF Health Sciences Pharma Biotech PBR
With the historic vote by the UK to leave the European Union we have been asked by many of our clients and colleagues “What will the vote to leave the EU (Brexit) mean for pharmaceutical quality management and the role of the Qualified Person (QP)?” The only thing that is certain is that we are facing at least two, and probably more, years of unprecedented uncertainty.
White Papers
NSF: Techniques to tackle our current Complexity Crisis
| By NSF Health Sciences Pharma Biotech PBR
Over the last 30 years we have seen levels of complexity in the pharma industry increase dramatically. It’s getting close to a crisis point. Although some complexity is triggered by events we can’t influence (regulations, globalization and the like), most is created by choice.
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