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药厂gmp车间很多人可能不是很了解，GMP实施工作是一项工程，涉及到对国家药品监督管理法规、规章、规范的理解和消化，也涉及到制药企业在硬件方面的完善和提高，工作细、任务重。那么，药品如何申请GMP认证的呢？需要做好哪些工作？接下来小编为大家讲解一下！
Many people in the pharmaceutical factory's gmp workshop may not understand it very well. GMP implementation is a project, involving the understanding and digestion of the national drug regulatory laws, regulations and specifications, as well as the improvement and improvement of the pharmaceutical enterprise's hardware. The work is detailed and the task is heavy. So, how to apply for GMP certification? What needs to be done well? Next, let's talk about it!
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CIO合规保证组织按照审计程序要求，依据《药品生产质量管理规范》(2010年修订)对被审核企业申请范围、场所实施现场审计审核，出具审计报告，列出风险点，评价风险级别，提出整改建议，提升企业合规管理水平
The CIO compliance assurance organization shall, in accordance with the requirements of the audit procedure and in accordance with the Good Manufacturing Practice for Drugs (revised in 2010), conduct on-site audit on the scope and location of the audited enterprise's application, issue an audit report, list risk points, evaluate risk levels, put forward rectification suggestions, and improve the enterprise's compliance management level
服务对象
service object
药品生产企业、药品研发机构、药物中间体工厂、原料药工厂、药用辅料工厂、药包材工厂等需要第三方审计，评估其GMP符合性的企业。
Pharmaceutical manufacturers, pharmaceutical research and development institutions, pharmaceutical intermediates factories, API factories, pharmaceutical excipients factories, pharmaceutical packaging materials factories and other enterprises that need third-party audit to assess their GMP compliance.
药品GMP申报所需材料
Materials required for drug GMP declaration
与报申请书的同时，还应报送以下资料:
Along with the application form, the following materials shall also be submitted:
（1）《药品生产企业许可证》和《营业执照》（复印件）
(1) Drug Production Enterprise License and Business License (copy)
（2）药品生产管理和质量管理自查情况（包括企业概况、GMP实施情况及培训情况）。
(2) Self inspection of drug production management and quality management (including enterprise profile, GMP implementation and training).
（3）药品生产企业（车间）的负责人、检验人员文化程度登记表；高、中、初级技术入员的比例情况表。
(3) Registration form for the educational level of the person in charge and inspectors of the drug manufacturer (workshop); The proportion of high, medium and primary technical personnel.
（4）药品生产企业（车间）生产的组织机构图（包括各组织部门的功能及相互关系，部门负责人）。
(4) The organization chart of the drug production enterprise (workshop) (including the functions and relationships of various organizational departments, and the department heads).
（5）药品生产企业（车间）生产的所有剂型和品种表。
(5) List of all dosage forms and varieties produced by drug manufacturers (workshops).
（6）药品生产企业（车间）的环境条件、仓储及总平面布置图。
(6) Environmental conditions, storage and general layout of the drug manufacturer (workshop).
（7）药品生产车间概况及工艺布局平面图（括更衣室盥洗间、人流和物料通道、气闸等，并标明空气洁净度等级）。
(7) Overview of drug production workshop and process layout plan (including dressing room, washroom, people flow and material passage, air lock, etc., with air cleanliness grade marked).
（8）所生产剂型或品种工艺流程图，并注明主要过程控制点。
(8) Process flow chart of the produced dosage form or variety, and indicate the main process control points.
（9）药品生产企业（车间）的关键工序、主要设备验证情况和检验仪器、仪表校验情况。
(9) Verification of key processes, main equipment, inspection instruments and meters of drug manufacturers (workshops).
（10）药品生产企业（车间）生产管理、质量管理文件目录
(10) Contents of production management and quality management documents of drug manufacturers (workshops)
（11）新开办的药品生产企业（车间）申请GMP认证，除报送（2）和（10）项规定的资料外，还须报送开办药品生产企业（车间）批准立项文件和拟生产的品种或剂型三批试生产记录。
(11) When applying for GMP certification, a newly established drug manufacturer (workshop) must submit, in addition to the materials specified in Items (2) and (10), the project approval documents of the drug manufacturer (workshop) and the three batch trial production records of the varieties or dosage forms to be produced.
GMP认证阶段：
GMP certification stage:
1、预认证,迎接GMP现场检查
1. Pre certification, welcome GMP on-site inspection
2、GMP认证前的迎审培训
2. Training before GMP certification
3、对企业预先认证,发现问题及时改进
3. Pre certification of enterprises, timely improvement when problems are found
4、高效维护GMP体系运行,迎接GMP检查组现场检查
4. Effectively maintain the operation of the GMP system and welcome the on-site inspection by the GMP inspection team
五、GMP认证结束：
5、 End of GMP certification:
1、GMP认证结果跟进及领取证书
1. Follow up of GMP certification results and receipt of certificates
2、企业通过GMP现场检查后的进度跟踪
2. Progress tracking after the enterprise passes the GMP on-site inspection
3、领取GMP证书
3. Get the GMP certificate