When it comes to complying with federal regulations on your manufacturing facility, it's incredibly important to be aware of the big picture in order to meet every requirement and avoid any possible violations or punishments. One such regulation many small business owners may not be aware of is 21 CFR Part 11, also known as the FDA's current good manufacturing practice in manufacturing, packing, or holding of drugs; better known as 21 CFR SCADA . These regulation details requirements that need to be met when manufacturing and handling pharmaceutical drugs, including those produced in sterile environments such as clean rooms. Understanding SCADA Each food facility is unique. The type of foods it manufactures produces or stores will impact how it must be designed and managed. Some processes are considered low-risk, while others can pose serious threats to public health and safety if not handled properly. In general, food facilities fall into one of three categories: low-, modera...
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