Process Analytical Technology (PAT) is a standard mechanism used by Food and Drug Administration (FDA) to regulate and maintain standards in the process of pharmaceutical manufacturing in the United States. These standards are defined as Critical Quality Attributes (CQA) and are determined by measurement of Critical Process Parameters (CPP).
PAT has defined certain Critical Process Parameters related to the equipment that are used in the manufacturing of the product. Thus, by controlling CPP of the equipment, Critical Quality Attributes (CQA) can be kept within standard limits.
There are two main set of variables which determines the outcome of a pharmaceutical manufacturing process. The first set of variables is the variations in the attributes of the raw materials such as crystal structure, moisture content etc. The second set of variables comes from slight variations in working of manufacturing equipment at different times and under different conditions. These variations in the raw materials when combined with the variations in the batch process leads to significant variation in the final product.
Proper implementation of the PAT standards is very important and it takes into consideration following parameters:
- Determining a simple process with well-defined nuances and details.
- Defining a set of information that can be measured or determined using instruments that are available currently.
- Choosing the appropriate intervals between collections of data for testing the standards.
- Finding best methods for synchronization and analysis of data collected from samples.
It is extremely important to define standards for the pharmaceutical manufacturing process. This helps in ensuring that the medicines available in the market do not show significant variations in their quality and effects on users. It also acts as the strong measure by Food and Drug Administration to maintain necessary standards in the pharmaceutical manufacturing process in the United States.