Study On Design And Construction Control API Workshop

At the beginning of twenty-first Century, the pharmaceutical industry in the United States put forward the concept of quality by design"," drug drug research and development from the beginning to consider the quality of the final product, the key technological parameter determination, synthesis line selection, raw materials control must be studied in detail and then determine the production process. The modern pharmaceutical quality management concept from the initial drug quality is detected, to the quality of the drug is produced, and then to the quality of the drug is designed, has undergone a qualitative change.The design is based on an annual output of 15 tons of methylprednisolone for production, the anti-inflammatory effect of methylprednisolone sodium retention effect is strong, weak, and similar efficacy of prednisone. Methylprednisolone acetate suspension slow decomposition, lasting effect, can be used for intramuscular, intra-articular injection. Methylprednisolone sodium succinate is water soluble, can be used for intramuscular injection, or dissolved in glucose solution intravenously. Methylprednisolone market prospect is very considerable. Statistics show that, with USP36, EP7 quality standard and downstream raw materials (such as methylprednisolone methylprednisolone sodium succinate etc.) in Europe and the United States market capacity of more than 100 tons/year, sales of more than $300000000, and increased year by year.Covers directly or indirectly affect the design of all the hardware and software design of the drug quality, while covering the protection design of all hardware and software aspects of human health and prevention of environmental pollution, the production safety of the. Only through reasonable design, in order to ensure the production line and the products can meet the GMP, FDA, EDQM certification requirements, in order to maximize the reduction of pollution, cross contamination and mix up and error risk in drug production process. The main contents include:process design, equipment selection, layout design, safety design and preventive measures and other related process design. This design uses the data reference old production line data and related SOP, workshop layout, equipment selection process, after repeated demonstration based on the determined, new workshop construction smoothly, workshop operation is in good condition and through the domestic GMP certification.