Compliance with GMP for APIs

We have two factory buildings with a history which is in compliance with GMP. We also have extensive past experience in obtaining FDA approval. We operate our day-to-day activities under the management system in accordance with the various regulations such as GMP, ICH and PIC/S guidelines of each country as can be seen in the above diagram. In addition, from procurement of the raw materials, stocking, manufacturing of APIs through to shipment, each department also cooperates with all others to manufacture one single product (see diagram below). In the manufacturing department and quality control department, we manufacture and test precisely based on the instruction and recording manual. In the quality assurance department, we ensure that the product quality is verified by manufacturing and test records. In this way, each of the respective departments fully complies with the required GMP conditions.