The importance of the quality of (API) in the development of new drugs

The importance of the quality of active pharmaceutical ingredients in the development of new drugs
National and international drug regulations, such as the FDA, stipulate that the manufacturing process of pharmaceutical products must be validated, focusing on the 3 validation phases: design, process qualification and continuous validation. Therefore, the definition of the process from the beginning of the design is of utmost importance and one of the main factors that define and describe the success of the manufacturing process are the active pharmaceutical ingredients.
The selection of active pharmaceutical ingredients must start at the drug development stage, as the efficacy of the drug depends on it. Then the manufacturing process must be adapted to its physical and chemical characteristics to maximize the efficacy of the drug.
The process of manufacturing a new drug requires many elements, of which the active pharmaceutical ingredients are the most important because the active pharmaceutical ingredients are the basis for the design and development of a new drug, so the quality of the active pharmaceutical ingredients must be strictly controlled, which will affect the quality of the future finished drug.
To ensure that the active pharmaceutical ingredients perform perfectly during the new drug development process, the overall quality of the drug must be evaluated from the design stage of development, including: dosage form, route of administration, dosage, appearance, solubility, stability, container sealing, etc. Therefore, the process of launching a new drug is a continuous process of finding and solving problems, which can take several years or even more than ten years.
The quality of active pharmaceutical ingredients is reflected in their physicochemical properties. The quality of active pharmaceutical ingredients is crucial for the design and development of a pharmaceutical product, so the choice of a good API supplier is also vital.