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Latest White Papers
Data Integrity A Closer Look
| By NSF International
Data integrity remains a perennial hot topic impacting the pharma biotech industry and the trend has been picking up steam; the number of data integrity-related warning letters has increased consistently since 2010. A number of new guidance documents came out in 2016 by FDA, MHRA, EMA PIC/S and the WHO and yet companies continue to grapple with data integrity issues.
White Papers
Hierarchy For Capa Effectiveness
| By NSF International
Have you ever reviewed an investigation report and wondered whether the proposed corrective and preventive action (CAPA) would be effective? Sometimes, we shrug our shoulders and say, “At least they put something in place”. We all know that the FDA expects us to include an effectiveness check, but do we have enough guidance to make these checks meaningful? NSF suggests that you consider these three questions: 1. What will you measure? 2. When will you measure it? 3. What is your acceptance standard?
White Papers
Is Fear of Risk Your Biggest Risk?
| By NSF International
In this white paper, NSF International's Martin Lush gives his insights into the pharmaceutical industry's relationship with risk. It includes five steps to help you become risk smart.
White Papers
Risk Assessment: A Closer Look
| By NSF International
NSF International’s Andy Barnett takes a deeper look into ICH Q9, Quality Risk Management, with particular focus on the failure mode and effects analysis tool for risk management.
White Papers
Aging Facilities
| By NSF International
Aging facilities is a trendy catchphrase that has taken hold in the biopharmaceutical industry. This white paper by NSF International’s Nicholas Markel provides a few questions to determine if you have an aging facility as well as how to address any issues you may have.
White Papers
Improved-patient-safety-from-new-drug-delivery-device
| By Haselmeier
Clinical trials or industrial use of the self-injection system: The D-Flex Pen by Haselmeier is part of a brand new generation of drug delivery devices.
White Papers
NSF: Global Selection Considerations for CMO When Conducting Due Diligence
| By NSF International
Deciding to use a CMO requires a thorough due diligence exercise conducted both as desktop and on-site reviews. This NSF white paper by Maxine Fritz provides the fundamental factors to consider when engaging and deciding on a CMO.
White Papers
NSF: Time To Move Beyond Mediocre CAPAs and Make Them More Effective
| By NSF International
Have you ever wondered why some of your CAPAs fail to achieve the desired improvement? Wouldn’t it be nice if there were a way to evaluate the CAPA before you implement it? NSF proposes the use of our CAPA hierarchy, which will help investigators select a CAPA that is most likely to deliver the desired outcome. Read the white paper for more information on the hierarchy and find out how else to use it.
White Papers
Malvern: Understanding and minimizing polycaprolactone degradation during processing using multi-detector GPC and rheology
| By Malvern Panalytical
Measuring degradation related changes in molecular weight and rheology during polycaprolactone processing
White Papers
How Malvern Panalytical helped GSK India optimize their manufacturing process using
| By Malvern Panalytical
GSK India is headquartered at Worli, Mumbai with the manufacturing unit being located at Nashik. A second manufacturing facility at Vemgal, Karnataka is due to be completed in 2018.
White Papers
Malvern: Measuring the rheology of thermoplastic polymer melts
| By Malvern Panalytical
Using rotational and capillary rheometry to characterize polymer melts
White Papers
Malvern: Optimizing metal powders for additive manufacturing
| By Malvern Panalytical
Exploring the impact of particle morphology and powder flowability.
White Papers
Malvern:Establishing an analytical toolkit for the optimization of Li-ion battery electrode manufacturing
| By Malvern Panalytical
The electrodes used in Li-ion batteries have a defining influence on their electrochemical performance and are typically manufactured by coating a metal foil substrate with a multicomponent slurry made up of active electrode particles and conductive additives suspended in a binder solution.
White Papers
Do you have a robust and compliant CAPA System?
| By NSF International
Pharma biotech companies around the globe are struggling to juggle numerous priorities and challenges. One of their biggest struggles is to effectively manage CAPAs.
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