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Quality by Design (QbD) - Articles and news items

Whitepaper: Downstream biopharmaceutical operations

Application note: Downstream biopharmaceutical operations

Whitepapers, Z Homepage promo / 1 September 2016 / Kaiser Optical Systems, Inc

This Kaiser application note focuses on real-time, in situ process understanding using a Raman-based PAT approach. Raman spectroscopy is uniquely useful for biotechnology ‘Quality by Design’ (QbD) applications because it enables fast, non-destructive monitoring and control…

How & why to build a QbD process to optimise the efficiency of your freeze drying projects

How & why to build a QbD process to optimise the efficiency of your freeze drying projects

Supplier news / 1 July 2016 / Biopharma Group

Quality by design (QbD) for lyophilisation is about building a robust process that proactively flags critical points and ensures consistent delivery of the best quality product, not only by minimising risk but also through greater understanding of the process itself…

Application Note: MicroNIR PAT for blend monitoring

Application Note: MicroNIR PAT for blend monitoring

Whitepapers / 18 January 2016 / VIAVI

This paper discusses how the MicroNIR PAT spectrometer was used to monitor the blend uniformity of a number of designed blends of commercially available coffee, sugar and creamer and to jointly assess the sensory preference of the blends in a way that is typical of the process used by a pharmaceutical company to better understand the powder blending operation in tablet manufacturing…

PAT In-depth focus 2015

PAT: In-depth Focus 2015

Issue 6 2015, PAT & QbD, Supplements / 6 January 2016 / Caroline Richards

Featuring an overview of process analytical control; Beyond API monitoring: in-line Raman spectroscopy for process control; Monitoring, understanding and assessing pharmaceutical process and product quality; and a PAT roundtable…

David Elder

Use of the ‘purge tool’ in assessing mutagenic impurities

Issue 6 2015, PAT & QbD / 6 January 2016 / Dave Elder, GlaxoSmithKline and JPAG

The International Conference on Harmonization M7 text provides guidance on establishing acceptable levels of mutagenic impurities (MIs) . It also outlines the safety and quality risk management processes that manufacturers need to undertake to control MIs that may potentially affect the drug substance or drug product. Over the past decade, some of the most significant challenges facing the pharmaceutical industry have been linked to performing genotoxic risk assessments (GRAs) and implementing a control strategy, including the analysis of these MIs and potentially mutagenic impurities (PMIs) at very low levels (ppm) in drug substances and products…

The scope of PAT in real-time advanced control of tablet quality

The scope of PAT in real-time advanced control of tablet quality

Issue 2 2015, PAT & QbD / 20 April 2015 / Ravendra Singh, Marianthi Ierapetritou and Rohit Ramachandran: Rutgers University

Continuous pharmaceutical manufacturing together with process analytical technology (PAT) provides a suitable platform for automatic feed-forward/feed-back (FF/FB) control of the end product quality as desired by quality by design (QbD)-based efficient manufacturing. The precise control of the quality of the pharmaceutical product requires proactive, corrective actions on the process/raw material variability. Therefore, PAT tools are necessary to monitor the FF as well as FB process variables that need to be sent to the automatic real-time control system. This article highlights the scope of PAT in a combined FF/FB control system of a continuous tablet manufacturing process…

GlobalData US pharma market value

Experts make pharma predictions for 2015: The good, the bad and the ugly

Industry news / 2 February 2015 / CPhI Worldwide

Experts from CPhI Worldwide have shared their pharma predictions for 2015, suggesting that Continuous Manufacturing and QbD will expand, with FDA becoming ‘industry tutor’. However, pharma concerns about supply chain persist…


Advance with IFPAC pathway to quality manufacturing

Issue 6 2014 / 23 December 2014 / IFPAC

IFPAC® is the essential meeting place for the latest developments in Process Analytical Technology (PAT) and Quality by Design (QbD) within the Pharmaceutical, Biotechnology & related industries. IFPAC is known for being a collaborative forum to exchange ideas and network through panel discussions, evening sessions, poster sessions and the exhibition. For over 25 years IFPAC has brought together industry, academia, research institutions, manufacturers/suppliers, as well as International and US Regulatory Agencies to discuss the latest trends in technologies, standards and controls…

David Elder

Cocrystals : defining the opportunity

Issue 6 2014 / 23 December 2014 / Dave Elder, GlaxoSmithKline and JPAG

Cocrystals can help to address the manufacturability (flow, compaction, processability) as well as solubility/dissolution,hygroscopicity and stability properties of an active pharmaceutical ingredient (API)…

Multivariate Calibration Maintenance

The flexibility of regularisation processes for multivariate calibration maintenance

Issue 4 2014, PAT & QbD, Raman Spectroscopy / 5 September 2014 / Dr. John H. Kalivas, Editor for the Journal of Chemometrics and Applied Spectroscopy.

In the pharmaceutical industry, it is necessary to control, in a tight range, the active pharmaceutical ingredient (API) content of products, e.g., tablets or other powder blends. Thus, the API content needs to be continuously monitored. Preferably, analysis for the API content should be in-line (on site) allowing rapid and efficient quality control. It is well documented that spectroscopic methods, such as near-infrared (NIR) and Raman, in conjunction with multivariate calibration processes, can meet these goals under controlled conditions…

Lean Thinking

Lean, Six Sigma, people and organisations

Issue 4 2014, PAT & QbD / 5 September 2014 / Dr. Stephen McGrath, Teva Pharmaceuticals Ireland (TPI)

Organisations are constantly striving to drive down costs while maintaining the quality of their products and services. In recent years, much has been written in both the academic and practitioner literature on the application of Lean principles for the elimination of waste and focusing of energies on value-creating activities. In theory, the adoption of Lean principles by an organisation has the potential to provide the dual pay-off of increasing customer satisfaction while reducing cost. The bottom-line benefit of a successful Lean transformation process to an organisation is therefore obvious and the reported success stories for true Lean transformations are impressive. Quoted figures such as 90% reductions in inventory coupled with a 50% increase in productivity capture the attention and imagination of managers. However, such success stories remain elusive with a success rate of 10% or less being widely reported in the literature. This article explores factors influencing Lean transformation initiatives in organisations…

Novel methodologies for determining the mineral content of complex multivitamin tablets

Issue 4 2014, PAT & QbD / 5 September 2014 / Ryan Gosselin & Nicolas Abatzoglou, Pfizer Industrial Research Chair, University of Sherbrooke / Philip Quinn, Pfizer Industrial Research Chair, University of Sherbrooke and Process Analytical Sciences Group, Pfizer Canada / Joanny Salvas & Jean-Sébastien Simard, Process Analytical Sciences Group, Pfizer Canada

Pharmaceutical product manufacturing is a conservative environment because of the obligations to abide by rigorous operation protocols aimed at insuring the highest possible product quality. A relatively recent initiativeguidance, from the U.S. FDA (Food and Drug Administration) has encouraged innovation and development of PATs (Process Analytical Technologies) for improved process efficiency. This has created opportunities for technological development and application of available technologies…


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