Study For XH Pharm. API Process Optimization Management Mode

Over nearly60years of development, from none to all, from weak to strong, greatchanges have taken place in our pharmaceutical industries, but compared with thedeveloped countries there is a big gap, in our country the production of APIs (ActivePharmaceutical Ingredients) still dominates, the industry of APIs has importantsignificance. In recent years, with the improvement of people’s environmentalprotection consciousness, pharmaceutical production factors are becoming more andmore, which forces the upgrading of the industrial structure, so the upgrading ofindustrial structure for APIs will be imperative. Under the situation, there is greatsignificance in exploring the industry upgrading of APIs which are beingmanufactured。From the constraint factors of APIs’, this article elaborated the relevant theory andmethods of process optimization project. We analyzed the impact on the processoptimization mode from the following5aspects such as controls for starting material,personnel assignment, process technology, equipment modification andenvironmental protection. Aiming at the current situation that APIs’ production wasrestricted and urgently needed upgrading we put forward a set of research frameworkapplicable to API process optimization and gave an example of amlodipine processoptimization。The study for process optimization management mode mainly includes theestablishment of optimization project, the control of optimization factor, the checkand acceptance of optimization results. This article focuses on effective managementfor optimization factors control to solve the bottleneck problem of restrictingproduction technical。Establishment of optimization project is the key of process optimizationmanagement, mainly including three aspects: the expert group of XH pharm.organizes and reviews project proposals; evaluates the feasibility of proposed processoptimization project; signs a contract with the target development unit. For thoseprojects that the value potential is great, can significantly reduce production costs,improve product quality, save energy and reduce emission, company transferstechnology optimization capital to implement the project, so the process optimizationproject is established。Optimization factor control stage mainly refers to the important stage fromoptimization project establishment (namely from optimizing those elements affectingthe production) to check and acceptance for the optimization results, this stage is thesoul of process optimization project. In this article, we mainly optimize thefollowing aspects such as incoming raw materials control, research&developmentpersonnel assignment, process technology optimization, equipment modification andenvironmental protection during the process optimization project implementation. The intention is to improve product quality, save energy and reduce consumption, andreduce production cost.The project check before acceptance will be conducted when a project contractassessment standard is reached. For those projects that create significant economicbenefits, some material awards should be given according to the contribution towardsenterprise, awards were graded into one two three class: For the first class award,20%of creation profits is given; For the second class award,10%of creation profits isgiven; For the third class award,5%of creation profits is given; the intention is toimprove the enthusiasm and creativity of process optimization staff.The optimization of amlodipine process gained remarkable economic and socialbenefits.(1) The cost of raw materials for amlodipine is decreased from2100yuan/kg to600yuan/kg, the decrease extent in cost amounts to71.4%.(2) In the "three wastes" emissions: The emission amounts of “three wastes”decreased by nearly50%after amlodipine process were optimized, which solved thebottleneck problem of restricting production.This article uses "APIs process optimization project management mode of XHPharm." as a title to begin research, the reason is that XH pharm. and other chemicalAPI enterprises of our country generally take the old APIs as main products. As theincrease in the strength of environmental management, those enterprises whomanufacture the products of low technology content and low value-added will facethe danger of shutting down; to resolve this problem, I attempt to begin from the APIprocess optimization management, exploring a set of API process optimizationmanagement mode and searching a management method for product upgrading.