Implementation of PAT

The integrated quality system orientation afforded a flexible regulatory approach for implementation of PAT. For example, regulatory implementation plans can include ... 

Following the issuance of the PAT Guidance workshops are planned in the three ICH regions. The European Workshop will provide an opportunity for the EMEA and FDA PAT teams to further collaborate on regulatory implementation of PAT. Similarly the planned workshop in Japan will afford an opportunity to further strengthen the collaboration between FDA and MHLW. Health Canada has been invited to participate with FDA in the second PAT training program planned for the 2004-2005 fiscal year. 

Many of the quality improvement goals for implementation of PAT in the pharmaceutical industry have been achieved by companies in other industries, such as automobile production and consumer electronics, as a direct result of adopting principles of quality management. The lineage of modern quality management can be traced to the work of Walter Shewhart, a statistician for Bell Laboratories in the mid-1920s [17]. His observation that statistical analysis of the dimensions of industrial products over time could be used to control the quality of production laid the foundation for modern control charts. Shewhart is considered to be the father of statistical process control (SPC) his work provides the first evidence of the transition from product quality (by inspection) to the concept of quality processes [18,19]. 

With regard to drug manufacturers implementation of PAT, a Ust of 10 questions has been presented which provides an initial checklist for companies seeking approval of their plans [10,66] ... 

To provide our experience and knowledge base of implementation of PAT to new and experienced practitioners in the field as well as to observers and stakeholders of PA. 

While there are a number of factors driving the implementation of PAT in pharmaceutical development and manufacture, it can also be said that there are a number of barriers. The magnitude of these barriers is profoundly affected by the organizational culture within each pharmaceutical manufacturer, and frequently across sites within a single company. Several of these cultural issues have been spelled out in the literature,14 5 and there are additional issues related to the absence of infrastructure (both physical and human). A number of the potential impediments are cited here to provide context for those unfamiliar with the area. 

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