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The manufacturing of Active Pharmaceutical Ingredients (APIs) is a complex journey that involves several meticulously orchestrated steps. Each phase plays a critical role in ensuring that the final product meets the necessary standards of quality, purity, and efficacy. Here, we will delve into the key stages of the API manufacturing process, shedding light on the essential procedures that pharmaceutical companies undertake.


Understanding PQQ


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Quality control (QC) and quality assurance (QA) are fundamental components of the API manufacturing process. All steps of manufacturing must meet stringent regulatory requirements set by authorities such as the FDA or EMA. QC involves rigorous testing of raw materials and the intermediate and final products to ensure they meet predefined standards. These tests often include chemical analysis, microbiological testing, and stability studies. QA, on the other hand, encompasses the overall system of procedures and protocols that ensure consistent production quality, including documentation practices, employee training, and validation of equipment.


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