摘要
制药工艺项目质量控制存在的问题主要有药物原材料质量不达标,工作人员综合素质普遍偏低,生产设备质量较低,制药技术不达标。提出了制药工艺项目质量控制的措施:强化对原材料的检验,加强专业工作队伍建设,构建完善的生产技术设备,提高生产技术水平。项目管理人员应安排专业人员定期对采购的原材料进行质量检验,确保原材料达到质量标准之后才能够用于药品生产。对于生产环节较为重要的技术人员,在选拔之前都需要进行相关的专业技术培训和专业技能考核。结合企业的药品生产情况、设备生产型号、设备生产参数来选择相应的生产设备,确保企业所构建的各种生产设备与生产技术方案相对应。结合药品的实际生产情况优选出适合本生产线的生产技术和生产设备,避免药品生产存在严重偏差。
The problems in the quality control of pharmaceutical process projects mainly include the lack of quality of raw materials for pharmaceuticals,old production equipment and outdated pharmaceutical technology.This article proposes measures for the quality control of pharmaceutical technology projects:strengthen the inspection of raw materials,strengthen the construction of professional work teams,build perfect production technology equipment,and improve production technology.The project management personnel should arrange professionals to regularly inspect the quality of the purchased raw materials to ensure that the raw materials meet the quality standards.Carry out relevant professional technical training and professional skill assessment for key technical personnel in the production process.Select the corresponding production equipment according to the enterprise’s pharmaceutical production situation,equipment production model,and equipment production parameters,to ensure that the various production equipment constructed by the enterprise correspond to the production technology plan.According to the actual production situation of medicines,the production technology and production equipment suitable for this production line are selected to avoid serious deviations in medicine production.
作者
杨庆峰
Yang Qingfeng(Heilongjiang Heibao Pharmaceutical Co.,Ltd.,Mudanjiang 157000,China)
出处
《黑龙江科学》
2020年第10期84-85,共2页
Heilongjiang Science
关键词
制药工艺项目
质量控制
问题
完善措施
Pharmaceutical process project
Quality control
Problems
Improvement measures
