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Importers of pharmaceutical intermediates navigate a complex web of regulations, logistics, and quality assurance processes to facilitate the timely delivery of products. One of the key responsibilities of these importers is to comply with the stringent regulations that govern the pharmaceutical industry. Different countries have varying standards for the quality and safety of drug components. Importers must ensure that the intermediates they source meet the necessary legal and regulatory requirements to prevent any disruptions in the supply chain.


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Since the beginning of the year, tire, chemical, steel, chemical fertilizer and so on collective price rise, the enterprise was greatly impacted, product profits were seriously squeezed……The price of raw materials has spiralled.
Nearly 100 chemical enterprises have stopped production, adding insult to injury!

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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