abbr.药品生产质量管理规范(GoodManufacturingPractice)
All numbering within this section coincides with actual numbering in the GMP Provision.───本节中的所有编号与GMP规定的实际编号一致。
Process validation is a key in execution of GMP in pharmaceutical enterprise.───工艺验证是制药企业实施GMP规范的关键问题。
These contract laboratories are not subject to routine GMP inspections.───这些合同式实验室不必接受GMP的例行检查。
It may not be cost-effective to locate storage tanks as close as possible to the point of use, within high-cost, GMP -finished areas.───在高成本、区域内,尽可能靠近使用点安置贮水罐并不会节约成本。
The productive process is sealed and no dead corner, granulating uniform, easy to clean. It conforms to the requirements of GMP.───生产过程密闭无死角,制粒均匀、清洗方便,完全符合GMP要求。
It would be unrealistic to expect drug product GMP concepts to apply to the production of these progenitors.───使制剂的GMP概念适用于这些物质的生产是不现实的。
Create the GMP self-inspection plan of the company and participate in its implementation.───负责制定公司GMP自检计划,并参与组织实施。
The system of quality assurance incorporating GMP and quality control should be fully documented and its effectiveness monitored.───结合GMP和质量控制的质量保证系统应该完全文件化并有效监督。
Hualan is the largest producer of vaccine in Asia with a state of the art facility that operates according to sFDA GMP and EU guidelines.───华兰是与最先进的设施,国家在亚洲最大的疫苗生产商的操作根据国家药监局GMP和欧盟的指导方针。
Second, We also perform GMP quality system on additive; the behavior is the first executant in this industry, to keep the stable quality of product.
Germany GMP Architectural Firm enjoys high reputation in Europe and World, ranking No. 1 in Germany. Among Top hundred architectural firms, GMP ranks the fifth place.
Familiar with quality system requirements of GMP, ISO, FDA and related regulatory.
Responsible for ensuring GMP compliance in production department activities.
A pilot plant complies with GMP has been established for trial production.
Do you establish a well-organized GMP documentation system?
The general circumstances on the conception, quality of GMP and Chinese GMP for radiopharmaceutical manufacturers are introduced briefly.
To file the batch record in the GMP library termly.
A full general GMP inspection is carried out in each year. In addition, inspections for parts of GMP system will be carried out every month.