GMP for APIs
Good Manufacturing Practice (GMP) is a set on important requirements of the drug manufacturing process. It is a system for ensuring that active pharmaceutical ingredients (APIs) are produced safely, consistently and in compliance with relevant regulatory standards. What is GMP? GMP stands for Good Manufacturing Practice and refers to a set of guidelines that must be followed when manufacturing APIs. These guidelines are designed to ensure that the production process meets a certain level of quality control, safety and consistency. They have been developed by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines
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