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为帮助您迅速达到中国或欧美GMP?水平，我们按如下流程：
To help you quickly achieve Chinese or European GMP? Level, we follow the following process:
√产品引进，根据客户需求，我们可以提供各种形式的合作方式帮助客户引进产品；
√ Product introduction: According to customer needs, we can provide various forms of cooperation to help customers introduce products;
√项目实施方案和项目计划的制定；
√ Formulation of project implementation plan and project plan;
√厂房、设备、设施改进；
√ Improvement of plant, equipment, and facilities;
√人员培训、流程分析与文件体系；
√ Personnel training, process analysis, and document system;
验证体系建立、验证方案编制及异常情况处理，验证报告审核；
Establishment of verification system, preparation of verification scheme, handling of abnormalities, and review of verification report;
√欧美标准GMP体系实施；
√ Implementation of European and American standard GMP systems;
√GMP认证检查前现场审计。
√ Site audit before GMP certification inspection.
药品 GMP 认证申请书（一式四份）；
Application for GMP certification of drugs (in quadruplicate);
《药品生产企业许可证》和《营业执照》复印件；
Copies of the "Drug Manufacturing Enterprise License" and "Business License";
药品生产管理和质量管理自查情况（包括企业概况及历史沿革情况、生产和质量管理情况、前次认证缺陷项目的改正情况）；
Self inspection of drug production management and quality management (including enterprise profile and historical evolution, production and quality management, and correction of previous certification defects);
药品生产企业组织机构图（注明各部门名称、相互关系、部门负责人）；
Organizational chart of the pharmaceutical manufacturing enterprise (indicating the name of each department, mutual relationship, and department head);
药品生产企业负责人、部门负责人简历；依法经过资格认定的药学及相关专业技术人员、工程技术人员、技术工人登记表，并标明所在部门及岗位；高、中、初级技术人员占全体员工的比例情况表；
Resume of the person in charge of the pharmaceutical production enterprise and department; Registration form for legally qualified pharmaceutical and related professional and technical personnel, engineering and technical personnel, and skilled workers, indicating their departments and positions; Table showing the proportion of high, medium, and junior technical personnel among all employees;
药品生产企业生产范围全部剂型和品种表；申请认证范围剂和品种表（注明常年生产品种），包括依据标准、药品批准文号；新药证书及生产批件等有关文件资料的复印件；
List of all dosage forms and varieties within the production scope of the drug manufacturing enterprise; Application for certification of the scope of agents and varieties table (indicating perennial production varieties), including the basis for standards, drug approval number; Copies of relevant documents such as new drug certificates and production approvals;
药品生产企业周围环境图、总平面布置图、仓储平面布置图、质量检验场所平面布置图；
Environmental map, general layout plan, warehouse layout plan, and quality inspection site layout plan of the pharmaceutical production enterprise;
药品生产车间概况及工艺布局平面图（包括更衣室、盥洗间、人流和物流通道、气闸等，并标明人、物流向和空气洁净度等级）；空气净化系统的送风、回风、排风平面布置图；工艺设备平面布置图；
Overview and process layout plan of the pharmaceutical production workshop (including changing rooms, bathrooms, pedestrian and logistics channels, air locks, etc., and indicating the direction of people, logistics, and air cleanliness level); Layout plan of air supply, return, and exhaust of air purification system; Layout plan of process equipment;
申请认证型或品种的工艺流程图，并注明主要过程控制点及控制项目；
Process flow chart of the type or variety to be certified, with main process control points and control items indicated;
药品生产企业（车间）的关键工序、主要设备、制水系统及空气净化系统的验证情况；检验仪器、仪表、衡器校验情况；
Verification of key processes, main equipment, water production systems, and air purification systems of pharmaceutical manufacturers (workshops); Check the calibration of instruments, meters, and scales;
药品生产企业（车间）生产管理、质量管理文件目录。
Directory of production management and quality management documents for pharmaceutical manufacturing enterprises (workshops).