Process Analytical Technologies (PAT)

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PAT Roundtable: trends and issues

7 February 2009 | By

European Pharmaceutical Review invited four individuals to discuss their views and opinions on current trends and issues surrounding PAT.

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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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From data to knowledge through smart Process Analytical Technologies (PAT) and process systems engineering

3 December 2008 | By

Pharma-Chem and bio-pharma development and production are now being profoundly influenced by the FDA PAT1 initiative with spectroscopic instrumentation being increasingly applied, or at the very least explored in product and process development and for on-line real-time process applications. The issues related to robust spectroscopic data analysis and calibration modelling…

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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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Quality by Design, Validation, and PAT: operational, statistical, and engineering perspectives

2 August 2008 | By

Dr. Janet Woodcock’s exhortation (ISPE Annual Meeting, 7 November 2005) that 21st century life science manufacturers should be ‘maximally efficient, agile and flexible’ and produce high quality drug products ‘without extensive regulatory oversight’ has been widely reported as a wake-up call to our industry.

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Industry Insight: Exceeding innovation excellence

2 August 2008 | By

As one of the world’s leading suppliers of products, solutions, and services to the Life Sciences sector, ABB is uniquely positioned to meet the current and future business and regulatory needs of the Life Sciences industry including Pharmaceuticals, Biopharma, and Biomedical...

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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…

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Wyeth’s PAT variations submitted through the EMEA Worksharing Procedure

19 June 2008 | By Graham Cook PhD, Senior Director, Process Knowledge/Quality by Design, Wyeth Pharmaceuticals

In June 2006, the EMEA called for nominations from companies to participate in the pilot phase of a worksharing exercise for Quality variations1. Worksharing is a key element in the revisions to the variations proposed by the European Commission, which are intended to streamline the process for making changes to…

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Expo sets a new standard in PAT implementation

19 June 2008 | By

PAT implementation gurus’ Expo Technologies talks to European Pharmaceutical Review about PAT and why they are at the top of their game.

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PAT – reducing the cost of quality in consumer products manufacturing

19 June 2008 | By

The ease in making process analytical measurements (typically spectroscopic) in manufacturing has provided a unique opportunity to obtain up-to-date information for making timely process correction decisions. At-line methods provide near-time information without the need for elaborate process control interfacing upfront. This approach works well for batch processing applications or unit…

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QbD and PAT – 2008 is the year it goes mainstream

7 April 2008 | By

Since the FDA revolutionary white papers[1,2] in 2004, the industry has talked non-stop about the potential of PAT (Process Analytical Technology) and more recently, QbD (Quality by Design). These topics have found regular spots in conferences, press and internal company discussions. It has been widely stated3 that the benefits are…

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PAT: not a purpose in itself

19 March 2008 | By

The process analytical technology guidelines have been a hotly debated topic within the pharmaceutical industry ever since they were made public in 2004. This also holds true at Johnson & Johnson Pharmaceutical Research & Development (J&JPRD), Division of Janssen Pharmaceutical N.V. In recent years, the company has introduced PAT tools…

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Product Quality Lifecycle Implementation (PQLI) – providing practical solutions

23 January 2008 | By Bruce Davis (Chairman of ISPE’s International Board of Directors)

This article discusses ISPE’s Product Quality Lifecycle Implementation (PQLI) initiative, which is to provide practical guidance for implementation of ICH Q8, Q9 and Q10. It represents the author’s individual opinion. It should be noted that PQLI is an evolving work area and so will continue to develop beyond the position…

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PAT: a comprehensive guide

23 January 2008 | By

European Pharmaceutical Review presents a comprehensive guide to PAT addressing the challenges and advancements that are impacting upon PAT implementation in 2008 and beyond...

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The future direction of ASTM E55 Committee on manufacture of pharmaceutical products

23 November 2007 | By Steve Simmons, Head of Process Knowledge QbD, Wyeth Pharmaceuticals

ASTM Committee E55 formed in April of 2003 as a result of FDA’s GMPs for the 21st Century Initiative and the subsequent Guidance, “PAT – a framework for innovative pharmaceutical manufacturing and quality assurance.” Focusing on process understanding and flexible manufacturing, FDA encouraged the pharmaceutical industry to utilise the consensus…