Process analytical technology requirements

To facilitate adoption or approval of a PAT process, manufacturers may request a preoperational review of a PAT manufacturing facility and process by the PAT team by contacting the FDA Process Analytical Technology Team at PAT cder.fda. gov. ft should be noted that when certain PAT implementation plans neither affect the current process nor require a change in specifications, several options can be considered. Manufacturers should evaluate and discuss with the agency the most appropriate option for their situation. 

The preparation phase is arguably the most critical step in the path toward PAT implementation. Process analytical technology projects are inherently multidisciplinary, requiring acceptance and buy-in from corporate divisions which sometimes... 

Since the field of Process Analytical Technology is currently a very active field in various industries, the contents of such a book will rapidly become historical, requiring revision to reflect the current state of the work. It is hoped that the discussions presented here will serve as a basis for those seeking to understand the area better, and provide information on many practical aspects of work done thus far. 

Validation and process analytical technology (PAT) require that we find and control the primary sources of product and process variation. Not many people realize that the current good manufacturing practice contain the words validation and variability in the same sentence. Such control procedures shall be established to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product (1). 

Often, the chemist tends to report Here is the process. These are the starting materials and reaction conditions. The product is obtained (analytically determined) with a good yield. Let the engineers deal with the rest of it from now on . This attitude may cause serious damages and losses. Until the chemist himself is confident that all the chemical, technological and economic aspects of the developed process meet the required criteria, his work is not finished. ... 

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