Quality by Design White Papers & Case Studies

1. Implementing PAT And Qbd Real-Time Particle Size Measurement For The Pharmaceutical Industry
   6/8/2012

   As the pharmaceutical industry implements PAT and QbD, their symbiotic nature becomes increasingly obvious. Both are catalysts towards the longer term goals of continuous operation and real-time release — the realization of a transformed way of working. This article reviews changing practice within the pharmaceutical industry using the example of real-time particle size analysis to explore the analytical solutions needed and the benefits they deliver. By Malvern Instruments

2. Pharmaceutical Manufacturing: The Challenge Of Setting Effective Product Specifications
   6/8/2012

   Setting meaningful and realistic specifications is an essential element of Quality by Design (QbD). Well-defined specifications control product performance since they derive from correlations between clinical behaviour and the variables measured routinely during processing and for QC. This paper examines the process of setting specifications, taking as an example particle size, a critically important parameter for many pharmaceutical formulations. By Malvern Instruments

3. Quality By Design In Biomanufacturing
   12/22/2011

   QbD is increasingly required in our industry, but there are still gaps in understanding how QbD applies to the biomanufacturing process.

4. Accelerating Generic Approvals: 5 Keys To Being First To Market
   12/12/2011

   Competition in the generics market has never been greater. At a time when many of the most successful drugs are reaching the patent cliff, opening the floodgates for generic substitutes, generic companies are rushing to target the best candidates and enter the market first.

5. MTOSoftgels: Providing Cohort Specific Hand Filled Softgel Capsules For Dose Escalation Studies
   11/2/2011

   Formulation and automated manufacture of capsules for early phase dose escalation clinical trials can be costly and wasteful. By Lisa Z Crandall

6. White Paper: Advancing Regulatory Science For Public Health
   12/9/2010
   This document outlines a broad vision for advancing regulatory science and unleashing its potential to improve public health. It discusses the role of the FDA, working with partners, to strengthen the field, both within the agency and throughout the Nation. By Food and Drug Administration (FDA)
7. Case Study: Wyeth Pharmaceuticals, Ireland, Getting Production Down PAT
   2/28/2010
   The 10th-largest pharmaceutical company in the world, Wyeth Pharmaceuticals, features strongly in the development of innovative products in the pharmaceutical sector and biotechnology. By Siemens Industry, Inc.
8. Managing Risk And Driving Profitability With Today's Process Analytical Technologies In the Pharmaceutical Industry

   Over the past few decades, terms such as Lean Six Sigma, Total Quality Management, and Continuous Improvement Strategy have become increasingly common in discussions of manufacturing plans.

9. Monitoring Chemical Processes For Early Fault Detection Using Multivariate Methods

   Multivariate Statistical Process Monitoring (MSPM) has been established as a valuable tool for ensuring reliable product quality in the process industry. However, many organizations today are still not fully utilizing its potential to make significant improvements in their production environment. By Dr Frank Westad, Chief Scientific Officer, CAMO Software

10. Raising Expectations Of Excipients

    An excipient’s role has traditionally been viewed as merely a filler or binder contributing to the stability of the end product. The full value that a formulation can bring to a final dosage form; or the real importance of ensuring an excipient’s quality and performance; are often underestimated, overlooked, misunderstood, or disregarded. In reality, the functionality of the excipient can help determine whether or not a drug succeeds or fails. By Fred Monsuur, Julia Poncher W. R. Grace & Co