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What is Pharmaceutical Manufacturing? Pharmaceutical manufacturing is the making of medicines on an industrial scale. For a medicine to get to the manufacturing stage, it has already gone through all research and discovery phases, and has been thoroughly tested. The manufacturing stage is about following the same “recipe” to create the same medicine again and again. For this reason, manufacturing medicines isn’t really about science, it’s about systems. It’s about following processes and checking quality. This helps to make sure that the products are the same every time they’re made so that patients can rely on their medicines. For a tablet product, the manufacturing process can be broken down into a series of steps: Chemical Synthesis: Combining chemicals together to make the “raw medicine” (the part that has the medical effect on a patient). This is known as the Active Pharmaceutical Ingredient or API. Formulation or preparation: The medicine is then mixed with other ingredients (known as pharmaceutical excipients) that are needed within the final the product. Different pharmaceutical excipients serve different purposes in the final medicine. Examples include making sure it’s protected and stable enough to be packaged and get to the patient, making sure the API can be used by the patient’s body, or making sure the tablet is identifiable (which is important for patient safety). Processes like milling and granulation also happen here. Tablet compression: Shaping the final mix of ingredients into pills. Tablet coating: Often done to protect the pills and make them easier for a patient to swallow. All stages of pharmaceutical industry operations are closely regulated and monitored by bodies such as the US Food & Drug Administration (FDA) and the European Medicines Agency (EMA). This level of regulation ensures that products are made safely and correctly, every single time. Which is important, there doesn’t get to be “good” batches and “not so good” batches of medicine… for obvious reasons! Because of this, pharmaceutical manufacturing is a unique and highly regulated environment. Check out this video from AstraZeneca for an overview of the pharmaceutical manufacturing process…