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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:


PAT Supplement

PAT: In-depth focus 2014

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...

NIR Supplement - 100

NIR: In-depth focus 2014

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

Multivariate Calibration Maintenance

The flexibility of regularisation processes for multivariate calibration maintenance

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

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

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...

David Elder

Foreword: What does quality mean to you?

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...

Francisca Gouveia, 4Tune Engineering Ltd

Pharma development and manufacturing with QbD 2.0

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...

Pills in Wrapper

PAT for packaging: review of applications for expeditious, nondestructive quality testing

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.

PAT Supplement 2013

Process Analytical Technology (PAT): In-depth focus 2013

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
PAT Roundtable
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...

David Elder

ICH Q3D: Metal Impurities: A Critical Evaluation

22 October 2013  •  David Elder, JPAG and GlaxoSmithKline / Andrew Teasdale, JPAG chairman and AstraZeneca

Historically, control over metal impurities has been achieved via pharmacopoeial heavy metals limit tests, e.g. United States Pharmacopeia (USP) <231>. These tests involve the formation of a metal sulphide precipitate, but such methods are non-specific and inaccurate for many elements. As a consequence, there has been a concerted drive by industry, pharmacopoeias and regulators to develop more effective approaches to the analysis and control of elemental impurities, leading to a number of international guidelines...

Lean Six Sigma principles

Six Sigma: How Rottapharm is using Lean Six Sigma principles

20 August 2013  •  Richard Hayes, Continuous Improvement Manager, Rottapharm

From their headquarters based in Monza, Italy, Rottapharm’s long history of success began in 1961 with the creation of a small laboratory for independent research. The company from its early beginning has continuously invested in research, innovation and development of pharmaceutical products for distribution on a worldwide scale. After acquiring the German multinational Madaus Pharma in 2007, the Group is currently one of the most significant and prominent pharmaceutical companies in Italy and is present in over 85 countries worldwide. The field of research is above all the undisputed true mission of the company.

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