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Process Analytical Technology (PAT) & Quality by Design (QbD)
A selection of articles from European Pharmaceutical Review covering Process Analytical Technology (PAT), Quality by Design (QbD), Six Sigma, Near Infrared (NIR) and Chemometrics:
3 July 2015 • Payal Roychoudhury, PhD, formerly AstraZeneca
The past decade has been a period of unparalleled change and development in the fermentation industry. As the nature of this industry evolves, and in particular, with the increasing prominence of the new biopharmaceuticals (therapeutic proteins, diagnostic enzymes and monoclonal antibodies) the need for effective bioprocess monitoring grows in importance. In order to deliver the ‘revolution in clinical medicine’ promised by this new range of therapeutic agents, there is a pressing need to develop effective bioprocess monitoring techniques and technologies which can deliver robust, reproducible, stable manufacturing processes, as well as high quality data, not just on product levels but also relating to product authenticity and purity. So what is wrong with the current manufacturing practice in the biomanufacturing industry? Today, most fermentation processes suffer from poorly understood process interactions, empirical risk assessment and process locked in by validation; therefore, the existing procedural approach has helped foster ‘a climate of fear’ of innovation itself.
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...
5 January 2015 • Prabir Basu, João A. Lopes
This PAT In-Depth focus explores current challenges posed by the slow uptake of Process Analytical Technology within the pharmaceutical and biopharmaceutical industries. The advantages of incorporating PAT into the pharmaceutical process are highlighted in two informative articles, and possible solutions to its lack of popularity surmised...
5 September 2014 • José Manuel Amigo, Milad Rouhi Khorasani, Jukka Rantanen, Poul Bertelsen, Lizbeth Martinez
In this free-to-view NIR in-depth focus: Moving towards continuous manufacturing with NIRS and NIR-CI systems, Monitoring of pharmaceutical powder mixing by NIR 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...
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...
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...
3 July 2014 • Dave Elder, GlaxoSmithKline and JPAG
An effective quality risk management (QRM) process ensures proactive identification and control of potential issues that may arise during development and commercialisation. Where quality is defined as the degree to which a set of intrinsic properties of a drug product, its underpinning manufacturing process, and any supporting processes fulfils the pre-determined criteria...
3 July 2014 • 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. In the past, commercial manufacturing emphasis was on full compliance with initially established product specifications leading to a perception of quality assurance based on testing, and avoiding later changes after regulatory submission. Although final product testing is an important element of quality control, final product quality can be measured but not modified, leading to product rejection or reprocessing activities and underperforming business outcomes, two kinds of waste according to lean manufacturing...
15 April 2014 • Jose Montenegro-Alvarado, Bradley Diehl, Jean-Maxime Guay, Steve Hammond, Hiwot Isaac, Ben Lyons, Conor McSweeney, Seamus O’Neill, Jean-Sébastien Simard and Joep Timmermans, Pfizer Inc.
This article reviews some emerging applications of Process Analytical Technologies (PAT) for packaging quality testing. Specifically, four commercially-available packaging applications are explored in further detail: Raman spectroscopy for rapid material identification testing of polymeric packaging materials; vision-based elastic deformation for non-destructive blister integrity testing; X-ray monitoring for inline blister fill inspection; and thermal imaging for inline verification of bottle foil seal integrity. For each application, a brief review is provided stating technology capabilities and principles of measurement as well as sharing example(s), other relevant remarks covering some practical aspects and comments on considerations for building a business case for these technologies.
16 December 2013 • Morten Allesø, Anette Seo Torstenson, Mette Bryder and Per Holm, Chemical & Pharmaceutical Research (H. Lundbeck A/S), Anneleen Burggraeve, Tom Van den Kerkhof, Jeroen Geens, Lieve Bijnens and Mario Hellings (Johnson & Johnson)
Presenting a rational approach to QbD-based pharmaceutical development: A roller compaction case study
PAT for pharmaceutical spray drying
Show Preview: IFPAC® 2014
Foreword: ICH Q6A – Specifications: Test procedures and acceptance criteria for new drug substances and new drug products: chemical substances
15 December 2013 • Dave Elder, GlaxoSmithKline and JPAG
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 to all APIs and drug products, i.e. description, identity, assay and impurities; as well as those specific tests which are applicable on a case-by-case basis. Thus, specifications are critical quality criteria that are proposed and justified by the manufacturer and subsequently approved by the licensing authority...
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