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App Note: JDSU – Fit-for-Purpose MicroNIR Spectrometer
Miniature and cost-effective NIR spectrometers are starting to facilitate QbD adoption...
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Quality by Design (QbD)
whitepaper
Application note: Bruker Optik – TANDEM FT-NIR for on-line tablet characterisation
Pharmaceutical manufacturers are required to enhance their critical quality performances. This is being encouraged by the FDA, which is pushing towards using modern process analytical technology (PAT) to ensure the quality of the final product.
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Process Analytical Technology (PAT): In-Depth Focus 2013
In this Process Analytical Technology (PAT) In-Depth Focus: Presenting a rational approach to QbD-based pharmaceutical development: A roller compaction case study, PAT for pharmaceutical spray drying, PAT Roundtable, Show Preview: IFPAC® 2014...
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ICH Q6A specifications: Test procedures and acceptance criteria for new drug substances and new drug products: chemical substances
Specifications (test and acceptance criteria) for active pharmaceutical ingredients (APIs) and drug products are defined in ICH Q6A. It ‘establishes a set of criteria to which a drug substance or drug product should conform to be considered acceptable for its intended use.’ The guidance is sub-divided into universal tests applicable…
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Process systems engineering (PSE) in the pharmaceutical industry: past and future
15 December 2013 | By Christos Georgakis, Department of Chemical and Biological Engineering and Systems Research Institute for Chemical and Biological Processes, Tufts University and Gregory M. Troup, Merck Research Laboratories, Merck & Co., Inc
Process Systems Engineering (PSE) has had a profound impact in the chemical, petroleum and petrochemical industry in the last 30 - 40 years. Even though PSE has already started to make a significant impact on the pharmaceutical industry, there are substantial additional benefits that can be derived. The purpose of…
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ICHQ2(R1) Validation of Analytical Procedures – Challenges and Opportunities
The International Conference on Harmonisation (ICH) guideline for the Validation of Analytical Procedures (ICHQ2(R1)) currently covers validation procedures for the four most common analytical tests: identification tests, quantitative tests for impurities, limit tests for the control of impurities and quantitative tests for the active moiety(ies) in APIs (active pharmaceutical ingredients)…
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A pragmatic approach for the adoption of QbD principles for analytical method development and validation
18 April 2013 | By Heike Gottschalg, Rüdiger Gössl, Holger Memmesheimer and Holger-Thorsten Steinführer, Boehringer Ingelheim Pharma GmbH & Co KG
The principles of the application of Quality by Design (QbD) in the pharmaceutical industry in terms of development, manufacturing and control are well defined and described in the ICH guidelines Q8, Q9 and Q10. These guidelines mainly focus on the quality of the drug products, their manufacturing processes and the…
webinar
Real-time monitoring of the moisture content in different type of dryers by NIR spectroscopy as a PAT tool
8 April 2013 | By Metrohm NIRSystems
This webinar will discuss the use of NIR in the process that allows for monitoring low levels of residual moisture and other process constituents to yield better process control and endpoint determination...
webinar
Leveraging cutting-edge Rapid Microbiological Methods to gain a comprehensive understanding of your environment and a competitive advantage
5 February 2013 | By Abzil BioVigilant
This webinar offers insight from both an end user and a supplier in order to share with you compelling reasons to consider the use of RMMs to gain a better understanding of your environment while improving your competitive advantage...
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PAT & QbD Supplement (free to view)
20 June 2011 | By Magida Zeaiter - GlaxoSmithKline, Mark Morton - Phoenix Scientific Services, Joachim Ermer - Head of Quality Control Services Frankfurt Chemistry - Sanofi
Featuring articles: "A basis for innovation and continuous improvement of process understanding and control in pharmaceutical product development" by Magida Zeaiter, GlaxoSmithKline, "Flexible processing assures product quality" by Mark Morton, Phoenix Scientific Services and "Quality by design: A lifecycle concept for pharmaceutical analysis" by Joachim Ermer, Head of Quality Control…
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Real-time NIR monitoring of pharmaceutical blending processes with multivariate quantitative models
9 October 2009 | By Dr. Nicolas Abatzoglou, Professor and Chairman of the Department of Chemical & Biotechnological Engineering of the Université de Sherbrooke; Pierre-Philippe Lapointe-Garant, PAT Scientist and Jean-Sébastien Simard, Technical Services, both Wyeth Pharmaceuticals
Process analytical technology (PAT) initiatives are now an integral part of developmental efforts in the pharmaceutical industry. Many technical and scientific papers and even dedicated sections appear regularly in several pharmaceutical manufacturing publications. They may be part of a quality by design (QbD) project to better identify and understand critical…
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QbD and PAT: From Science to Compliance
30 July 2009 | By Pedro E. Hernandez-Abad, Associate Director; Jun Huang, Principal PAT Scientist II and Saly Romero-Torres, Principal PAT Scientist, both Wyeth Pharmaceuticals
Boards of health like the Food and Drug Administration and European Medicines Agency and ICH guidelines Q8, Q9 and Q10, provide a framework for Quality by Design (QbD) that fully integrates drug substance and drug product development with the principles of Quality Risk Management (QRM), Process Analytical Technology (PAT) and…
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PAT Initiative review 2008
10 January 2009 | By Martin Warman, Director, MWC Ltd
As the industry approaches the five year anniversary of the ground breaking regulator initiatives (the ‘PAT framework' and ‘cGMPs for the 21st Century'1,2), it is time to assess the impact they have had on the industry and to look forward to what the industry may look like in another five…
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Successful Process Analytical Technology (PAT) implementation in pharmaceutical manufacturing
29 September 2008 | By Thirunellai G. Venkateshwaran (Senior Director, New Products Quality, Global Quality and Compliance), John Levins (Senior Director, Technology Transfer & Process Innovation) and Stephen P. Simmons (Head of New Product Quality and Quality by Design), all Wyeth Pharmaceuticals
The use of Process Analytical Technology (PAT) while a relatively new concept to the Pharmaceutical Industry has been a tried and tested concept in the petrochemical industry for many years. The adaptation of PAT systems by the Pharmaceutical Industry was accelerated by the recent initiatives of the regulatory authorities globally…
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Siemens: innovation, industry and implementation
19 June 2008 | By
Siemens seeks to deliver breakthrough innovations to give customers a unique competitive edge, in turn enabling societies to master their most vital challenges and creating sustainable value. Siemens was one of the first suppliers to adopt the new guidelines of the Food & Drug Administration (FDA) and the European Agency…
