Batch Process
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Batch Process, as defined by the FDA, refers to: “A specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture” (Horowitz, 2012). Batch Process is a job which can run without any end user contact, or can be programmed to run whenever management permits. This process can deal with a large group of transactions at one time. These transactions are compiled and processed against a master file, which may be updated at the end of the day or even at the end of the month, or even at some other time period. Batch Processing has a “defined beginning and end, which is why batch processing is inherently a start-and-stop operation” (Horowitz, 2012). Batch processing is a program that can be performed with little to a bare minimum of human interaction within a company”
Why the Batch Process is used in the Pharmaceutical Business
Although technology continues to change, some businesses have opted not to do so. Oftentimes, it has to do with cost, and time and even training. The batch process “is how it has always been done, and the challenges to change from what is proven and accepted to something new can overcome continuous processings advantages” (Horowitz, 2012). In the pharmaceutical business there some products that are just better produced in batches, for example, powders for pills. By implementing the batch process within the pharmaceutical business allows them to “better handle the variables that come with powders, such as when active ingredients become concentrated in one area” (Horowitz, 2012).