Implementation of PAT in Pharmaceuticals Production Plants

Yehuda Shekel, Dr. Yehuda Shekel - Consultant, Jerusalem, Israel

PAT - Process Analytical Chemistry is not new. Crude oil refineries, oil tankers, food and agricultural machinerus and car industries started to implement PAT about 40 years ago.

The Pharmaceutical industry being a highly regulated one and due to FDA PAT initative started to implement PAT in 2004. Later, PAT turned out to be one of the very important tools in QbD - Quality by Design program initiated by FDA.

Those Pharmaceutical plants which succeeded in implementing PAT benefited a lot in terms of better product quality, shortening manufacturing time, less trouble shhting, less procduction ecpenses and better understanding of the manufacturing process.

Several pharma companies in Europe and USA successfully benefit from PAT and have continued with it to the present.

However, most of the Pharma compniea in Israel and worldwide have not succeeded in adopting PAT fully in their plants. Therefore, in recent years there has been some retreat in Israel and worldwide in implementing PAT in pharmaceutical DP/API plants.

There are several reasons for this phenomenon:

** Lack of PAT "know-how" and tremendous changes it made in terms of time, work force, in-process materials and in-stock materials and other resources.

** in planning and introducing, a new PAT unit involves a tight cooperation chemists, engineers, administrators, and managers that usually do not collaborate directly and routinely do not work side- by- side.

** in planning a new plant or enlargement of an existing DP or API products, it seems that the alternative of a plant based on PAT as the main QC methodology is usually not even considerd.