Quality by Design (QbD)

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Pharma development and manufacturing with QbD 2.0

3 July 2014 | By José Menezes, Institute of Biotechnology and Bioenginerring, IST, Universidade de Lisboa / Francisca Gouveia and Pedro Felizardo, 4Tune Engineering Ltd

Pharma and BioPharma industries are aware of the impact of production processes on sustainability of business operations. To improve performance, companies have recognised that it is necessary to better understand the drivers of both costs and revenues and the actions that can be put in place to address them.

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Bio-Contamination, Risk Profiling and Proactive Response

29 May 2014 | By TSI Inc.

This pharma webinar provides an overview of the new PHSS Bio-contamination Monograph and the value of real-time airborne viable particle detection in GMP classified areas.

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Detection, quantification and visualisation of protein interactions for hit profiling by high content screening

3 February 2014 | By Sigma-Aldrich

This pharma webinar provides an overview of how compound profiling using the PLA® (Proximity Ligation Assay) technology can be used for in situ analysis of protein interactions by high content screening as part of the hit-to-lead workflow, the key advantage being the ability to provide evidence for target engagement of…

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Navigating the Complexities of Pharmaceutical Manufacturing Regulations

8 January 2014 | By Rigaku Raman Technologies

This pharma webinar will introduce unconventional approaches to enhance quality programs with the use of modern handheld technology.

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App Note: JDSU – Fit-for-Purpose MicroNIR Spectrometer

23 December 2013 | By JDSU

Miniature and cost-effective NIR spectrometers are starting to facilitate QbD adoption...

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Application note: Bruker Optik – TANDEM FT-NIR for on-line tablet characterisation

16 December 2013 | By Bruker

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

16 December 2013 | By European Pharmaceutical Review

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

15 December 2013 | By David Elder (JPAG member and consultant)

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

20 August 2013 | By David Elder (JPAG member and consultant)

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…

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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...

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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…