The process analytical technology PAT initiative

As a result of the Process Analytical Technologies (PAT) initiative launched by the U.S. Food and Drug Administration (FDA), analytical development is receiving more attention within the pharmaceutical industry. Illustrating the importance of analytical methodologies, Thermal Analysis of Pharmaceuticals presents reliable and versatile characterization tools for the successful development of pharmaceutical products. It draws attention to the most widely applicable methods and demonstrates how to interpret the associated data. 

Quality control at every step of the manufacturing chain must be adapted to the needs of a growing market where products must be manufactured in a fast and robust manner. The concept of global quality control by assessing quality at every step of the production chain was introduced by the U.S. Food and Drug Administration (FDA), which launched the process analytical technology (PAT) initiative to transform approaches to quality assurance in every step of the process [1]. This initiative encourages the implementation of three basic ideas [2] ... 

The FDA s Process Analytical Technology (PAT) initiative is an effort to facilitate the introduction of new manufacturing technologies in the pharmaceutical... 

The recent FDA initiative on Process Analytical Technology (PAT) attempts to define a design space for unit operations such as compaction... 

Hussain AS. The Process Analytical Technology Initiative PAT and the Pharmacopeias. EDQM Spring Conference, Cannes, 3-4 May 2004. http // www.fda.gov/cder/OPS/EDQM.ppt. 

The most dramatic emerging initiative in biopharma manufacturing is the implementation of process analytical technology (PAT) controls. In the foreseeable future that initiative will be extended to laboratory environments, and will revolutionize the GLP regulations and their operation. 

With the onset of the QbD initiative (see Section 2.3.4), first codified in the ICH Q8 document in 2006, the above-mentioned broader definition of process analytical technology has somewhat evolved into parts of the key elements of the broad definition of QbD, resulting in a partial retraction of the term PAT back... 

The present review illustrates that UV-vis based process analytical technology is widely discussed, but published examples are still scarce. The pharmaceutical industry, driven by the FDA s PAT initiative, can be seen as a forerunner. This is reflected by the observation that many references in this chapter are (co-) authored by representatives from pharmaceutical companies like Glaxo Wellcome and GlaxoSmithKline, ° " ° Astra Zeneca, Novartis and Eli Lilly. ... 

Current and/or planned collaborations with other groups, based on lessons learned are shown in [ ] recommendations for other groups in the initiative are identified in. Abbreviations. PAT, process analytical technology FDA, food and drug administration. 

Since the publication of a very successful First Edition of Pharmaceutical Process Scale-Up, several crucial related FDA documents have been revised. Also, significant new FDA initiative the (the aforementioned Process Analytical Technology or PAT), has had a strong impact on the pharmaceutical industry. 

Hinz, D. C. (2006), Process analytical technologies in the pharmaceutical industry the FDA s PAT initiative, Anal. Bioanal. Chem., 384,1036. 

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