The Research About L-380Quality Control Trail Production Project From XH Pharmaceutical Company

Quality management is the important constitution of project management，Qualitycontrol is the key to quality management.With the escalation of the activepharmaceutical ingredient (API) industry structure, the new active pharmaceuticalingredient program would be implemented, therefore, a higher demand for qualitycontrol would be proposed.At present,the level of the research about API’s qualitycontrol in our country was lower than other developed countries.Therefore,it’s veryimportant to strengthen the quality control of API trail production projects,establish anframework fitted for API trail production projects.Several common conclusions are generalized by consulting literature,includingcompared the domestic and foreign research of project and API quality control andintegrated several quality management quality management concept:Enterpriseleadership’s determination and participation determines the product quality of theenterprise;The first goal of quality control is customer satisfaction; Qualitycontrol,quality improvement are continuous loop; Developed to measure qualitystandards, and in accordance with the standard implementation; Quality control is anenterprise the responsibility of all employees, and throughout all the links. The projectquality control of the relevant theories and methods were described. The influence ofproject quality control is analyzed by human, machine, material, method, environmentand other factors.Through the analysis of API’S Trial production project quality control presentsituation, the influence of pilot production project quality control reasons areelaborated, the necessity of API’S Trial production project quality control isconfirmed.Meanwhile, A quality control model of was Proposed in order to solve theproblem of the project quality control for trial production, The quality control modelincluded the stage of pre-production,pre-production process, process validation andsummary. Respectively expounds the three stages of quality control points,theexpected effect and the methods of quality improvement. The level of Quality for L-380is improved through the application of PDCA cycle and the related qualitycontrol tools.In conclusion,the API’S Trial production project quality control is an overall anddynamic process,and it requires a perfect control framework; the project quality controlis realized according to establishing efficient organizational structure, perfectinformation system, centering on quality control and making the quality controlresponsibility clearly.The preparation phase quality control is the security for theL-380trial production projects; The trial production preparation process is the basis forachieving quality control objective.The embodiment and achievement of trialproduction’s pro-control are according to the execution of SOP and BPR,theoptimizing the process operation process and controlling the key quality control points;summarize and verify are the most important stage for analysis of quality controlprocess and examination of quality control effect.