Log in or Register for enhanced features | Forgotten Password?
White Papers | Suppliers | Events | Report Store | Companies | Dining Club | Medical Devices | Videos
Pharmaceutical Business Review
Return to: PBR Home

White Papers Directory

Latest White Papers
Nano-structured Electrolyte Layers for Solid Oxide Fuel Cells
| By Phenom World
Increasing pollution of the atmosphere resulting in already noticeable rising average temperature needs an improvement of the efficiency of existing energy production technologies and the development of new retainable strategies for energy conversion. The scientific activities of the Institute of Energy Research in the Research Center Jülich GmbH (FZJ), one of Germany's largest "science factories", are concentrated on the development, testing and characterization of materials for such high temperature applications (solid oxide fuel cells (SOFC), advanced gas and steam power plants, plasma facing materials for future fusion devices).
White Papers
Nanoscale Material Characterization: a Review of the use of Nanoparticle Tracking Analysis (NTA)
| By Malvern Instruments
This white paper describes the central role of high resolution particle size and concentration measurement nanoparticle research. The technique of Nanoparticle Tracking Analysis (NTA) is described and compared to other characterization methodologies, and comparative papers are cited. A wide range of application studies is then summarized with specific reference to the use and value of NTA.
White Papers
Need Help Choosing a Heterogeneous Catalyst? (Europe)
| By Johnson Matthey Fine Chemicals
Johnson Matthey Catalysis and Chiral Technologies Heterogeneous Catalysts Application Table.
Production & Manufacturing > Fine & Speciality Chemicals > White Papers
Need Help Choosing a Heterogeneous Catalyst? (North America)
| By Johnson Matthey Fine Chemicals
Johnson Matthey Catalysis and Chiral Technologies Heterogeneous Catalysts Application Table.
Production & Manufacturing > Fine & Speciality Chemicals > White Papers
New Concept of Press Coating System for STYL’One
| By Medelpharm
Medelpharm is presenting the new ‘Press Coating Device’ for its STYL'One R&D Tablet Press. Press coating, also known as dry coating or tab-in-tab, is a technology that opens up new possibilities to achieve unexplored dissolution profiles. The device, developed by Medelpharm, encapsulates the cores within a shell made of one or two different blends, opening up a wide range of new applications.
Production & Manufacturing > Process & Production > White Papers
New Tablet Testing Solutions at ACHEMA 2012
| By Dr Schleuniger Pharmatron
Dr. Schleuniger® Pharmatron will present several new tablet testing instruments at this year’s Achema exhibition in Frankfurt, Germany from 18. – 22. June 2012. Highlights are a brand-new semi-automatic tablet hardness tester and a new tablet disintegration tester. In addition, the new generation of touch-screen operated tablet testers will be exhibited at booth G58, Hall 4.2.
White Papers
New ‘Measurement News’ publication from Rotronic
| By Rotronic
Rotronic has published ‘Measurement News’ featuring a wide range of unique and interesting projects and applications where temperature, humidity and CO2 measurement where critical. ‘Measurement News’ is available as a PDF for download from the Rotronic website - select Humidity & Temperature /Publications. Rotronic is a Swiss-based manufacturer of precision temperature, humidity and CO2 instruments.
White Papers
Nine Things you Need to Know About Continuous Monitoring Systems in FDA-Regulated Environments
| By Vaisala pbr
The white paper outlines nine crucial evaluation points that will allow you to select the monitoring system best suited to your monitored applications, controlled environments and GxP facilities.
Contract Research & Services > Clinical Trials > White Papers
Non - GLP Services Overview Fact Sheet
| By inVentiv Health
inVentiv Health Clinical provides high quality bioanalytical services across the continuum of drug development. With more than 100 dedicated scientific professionals with experience developing more than 1000 methods, we can provide consistently high quality performance and service for any bioanalytical project. Our two GLP-compliant facilities house more than 60 LC-MS/MS, 13 GC-MS/MS, and 20 robotic units, giving us one of the highest capacities in the industry. This flexible capacity, with our rapid data handling capabilities, keeps studies on track and timelines under control.
White Papers
Novel Co-processed Excipient for Directly Compressed Controlled Release Formulations
| By MEGGLE
A novel excipient comprising 50% lactose monohydrate and 50% hypromellose K4M was prepared via co-processing, integrating the parent materials into a monoparticulate structure offering superior functional performance and simplified processing compared to simple physical admixtures of the same composition. Powder flow, tablet compaction, and wettability showed enhanced performance as a result of excipient co-processing. API dissolution studies with slight compositional modifications and simplified manufacturing method demonstrated flexibility in tablet performance without altering the API release profile.
Production & Manufacturing > Fine & Speciality Chemicals > White Papers
NSF asks a Production Director for their views on moving forward with KPIs
| By NSF Health Sciences Pharma Biotech PBR
KPIs and the Production Director: Select Fewer, More Significant KPIs and Set Goals for Your Metrics
White Papers
NSF asks ex-MHRA Inspector about the Importance of KPIs and gets Interesting Results
| By NSF Health Sciences Pharma Biotech PBR
KPIs and the Regulator: I’m Looking for Quality Metrics, Management Review and Continual Improvement.
White Papers
NSF asks why Annex 1 is Important to you
| By NSF Health Sciences Pharma Biotech PBR
This white paper details the key reasons for the revision to EudraLex Volume 4, Annex 1: Manufacture of Sterile Medicinal Products. It outlines what you should be asking yourself regardless of the dosage form you are responsible for. It also includes a simple tool to assess the impact on your organization when there is a regulatory change.
White Papers
NSF determines what KPIs mean for Employees
| By NSF Health Sciences Pharma Biotech PBR
KPIs and Employees: Involve Us Upfront and Let Us Help Define Relevant Measures
White Papers
NSF Explains the Points to Consider when Auditing a Terminally Sterilised Drug Product
| By NSF Health Sciences Pharma Biotech PBR
When conducting an audit of the terminally sterilized pharmaceutical product process, the essential checklist outlined in this white paper by Maxine Fritz will help.
White Papers
NSF: Essential Rules When Investigating GMP Deviations During Sterile Processing
| By NSF Health Sciences Pharma Biotech PBR
This white paper by John Johnson outlines the key attributes to consider during sterile products manufacturing. It also details five key non-negotiables for investigating pharmaceutical GMP deviations or deficiencies in sterile processing.
White Papers
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.
White Papers
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
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.
White Papers
NSF: What Works and What Doesn’t When Changing your Quality Culture and Improving GMP Behaviors
| By NSF Health Sciences Pharma Biotech PBR
Ever wondered why 70% of change initiatives fail, or why 95% of New Year’s resolutions are forgotten by February? The same reason traditional training methods have little impact on workplace behaviors, and why the “carrot and stick” (reward vs. punishment) approach to changing behaviors doesn’t work. In this article, we detail how to really change your quality culture and improve GMP behaviors.
White Papers
NTA: Applications in Drug Delivery
| By Malvern Instruments
Part 5 of NTA 1000 publications review.
White Papers
NTA: Drug Nanocarriers
| By Malvern Instruments
Part 6 of NTA 1000 publications review.
White Papers
NTA: Exosomes and Microvesicles - General
| By Malvern Instruments
The study of exosomes and other cell-derived microvesicles is an area of rapidly growing importance and the subject of intense interest and research. The previous lack of suitable methods for their detection, analysis, enumeration and phenotyping is proving to be a significant limitation in these studies. This chapter shows the degree to which the technique of NTA is helping to address these problems.
White Papers
NTA: Nanoparticle Toxicity
| By Malvern Instruments
At the same time as an increasing interest in, and rapid development of, a wide range of materials and products containing nanoscale structures and engineered nanoparticles, awareness has grown that the longer term potential toxic effects of such materials and their potential environmental impact are poorly understood. Existing methods have been assessed and new methods sought by which such materials could be analyzed on a routine basis during development and manufacture.
White Papers
See all White Papers