Quality cannot be tested or made; it shall be designed. Therefore, during the R&D stage, factors such as formula, process, and packaging materials are crucial for the quality. As such, the company attaches great importance to the products' R&D. We pursued the optimized conditions for product development. Such matter requires a series of production trials and stability tests (including long-term tests and accelerated tests) to ensure the product design possess features of sustainable stability and effectiveness.

Through a series of tests, we standardized and formatted such condition, thus establish the manufacturing control standard, including the formulation list, manufacturing SOP, as well as specifications and methods for inspection. Such standard would be subsequently submitted to TFDA for inspection and registration. The production and manufacturing of products are subject to the approval from TFDA.

Before the mass production of new products, we must follow the relevant standards (such as formulation recipe, raw material specification standard, standard manufacturing process and quality control standard for finished products) to carry out work of manufacturing and inspection. Semi-finished products and finished products from mass production shall comply with our relevant standards for production process control. Our pharmaceutical products are manufactured in accordance with the international standard of PIC/S GMP and comply with the highest international operation standards in the pharmaceutical industry.

• Raw materials are crucial to manufacturing, and only raw materials with good quality can be used to produce premium products. According to the latest PIC/S GMP standard issued by TFDA, prior to the storage of drug ingredient, the QC personnel shall carry out sampling inspection per unit packing according to the actual storage quantity. QC personnel shall use Raman Spectrometer to determine if the content in each packing conforms to the packaging label, ensuring the accuracy of raw materials.
• In addition, prior to storage, all raw materials shall be inspected according to the inspection specifications of each raw material, to ensure the quality conforms to the specifications and the highest safety standards.Raw materials shall be stored in the appropriate environment according to the features and shall be managed according to COA and the expiration date printed on the packaging to ensure their quality. Meanwhile, we save samples from each batch of raw materials for future inspection and tracking.We also require suppliers to provide inspection report for each batch of raw material for reference and regularly evaluate raw material suppliers. Site checks may apply, when necessary, to ensure the quality of raw material from the supply end.

Instrument room generally uses instruments such as HPLC, Dissolution Apparatuses, FTIR, G.C., Fluorometer, Ultraviolet Spectrometer, Raman Spectrometer, and Automatic Potentiometric Titrator. The inspection instruments are regularly checked to ensure their performance being stable, and to optimize the control of our premium medicine.

The drug factories rely on the efficient air conditioning system to effectively control the cleanliness, temperature, humidity, and microorganism in the operating room. And the airflow shall be strictly controlled to avoid cross-contamination of drugs. The pure water manufacturing system is also an important supporting system, especially for the liquid formulation. Equipment cleaning requires clean water to prevent drugs being contaminated by bacteria, minerals and chemicals substances in water that may affect the quality.

The pure water manufacturing system designed by Chung Mei Pharmaceutical conforms to the most stringent water specifications, the United States Pharmacopeia. The system effective controls the operating environment and pure water quality, thus producing high-quality medicine.