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制药企业都要按照相应的生产质量管理规范（GMP）进行各项准备，首先要取得生产许可证，然后进行GMP认证，取得GMP证书后，方能正式地进行生产销售。保健食品企业、医疗器械企业虽然已取消GMP认证，但一样要严格按GMP进行各项准备，在申请生产许可证的现场检查时，完全是按照以前GMP认证现场检查的要求进行检查的。对于前述企业的认证咨询服务，无论是工作流程，还是工作内容，都有共同之处，我们总结归纳如下：
Pharmaceutical enterprises should make various preparations according to the corresponding production quality management specifications (GMP). First, they should obtain the production license, and then carry out GMP certification. After obtaining the GMP certificate, they can formally carry out production and sales. Although the health food enterprises and medical device enterprises have cancelled the GMP certification, they should also carry out all preparations in strict accordance with GMP. When applying for the production license, the on-site inspection is carried out in full accordance with the requirements of the previous GMP certification on-site inspection. The certification consulting services of the above-mentioned enterprises have something in common, both in terms of workflow and work content. We summarize it as follows:
（一）、合同商谈
（1） Contract negotiation
1、意向商谈，现场考察
1. Intention negotiation and site visit
2、如果企业有设计方面的需求，则我公司同时派设计人员到现场考察评估
2. If the enterprise has design requirements, our company will also send designers to the site for investigation and evaluation
3、签订合同
3. Contract signing
（二）、调研和策划
（2） , research and planning
1、现场诊断，提出硬件设施的整改意见
1. Make on-site diagnosis and put forward rectification suggestions for hardware facilities
2、与企业进行沟通和了解，提出管理体系的诊断意见
2. Communicate and understand with the enterprise and put forward diagnostic opinions on the management system
3、拟订GMP认证工作计划，形成书面文件
3. Prepare GMP certification work plan and form written documents
4、确定企业方代表，协助企业成立GMP认证工作小组
4. Determine the representatives of the enterprise and assist the enterprise to establish a GMP certification Working Group
5、建立企业质量管理体系，包括组织机构的核定和岗位职责的确定
5. Establish enterprise quality management system, including verification of organization and determination of post responsibilities
6、培训GMP基础知识
6. Training GMP basic knowledge
7、结合企业实际情况，编制GMP文件
7. Prepare GMP documents in combination with the actual situation of the enterprise
（三）、硬件建设准备
（3） Hardware construction preparation
1、咨询公司根据企业实际情况审核初步方案
1. The consulting company reviews the preliminary scheme according to the actual situation of the enterprise
2、咨询方专家审核硬件设施
2. Consultant experts review hardware facilities
3、设备咨询
3. Equipment consultation
4、厂房装修、设备、工艺管道安装结果确认
4. Confirmation of plant decoration, equipment and process pipeline installation results
5、其它硬件改造过程中企业需要进行的咨询
5. Consultation required by enterprises in the process of other hardware transformation
（四）、软件建设
（4） . software construction
1、由咨询公司根据企业的实际情况为企业编制符合GMP要求的全部管理软件
1. The consulting company shall prepare all management software meeting GMP requirements for the enterprise according to the actual situation of the enterprise
2、由咨询公司根据企业的实际情况编写符合GMP要求的全部管理软件和全部操作类软件（此种情况适合于企业技术力量较差的情况）
2. The consulting company shall compile all management software and all operation software that meet the GMP requirements according to the actual situation of the enterprise (this situation is suitable for the enterprise with poor technical strength)
3、如果企业自己制定操作类文件，则咨询方进行审核。
3. If the enterprise develops its own operation documents, the consultant shall review them.
（五）、培训指导（关于验证的具体培训在验证时进行）
（5） Training guidance (specific training on validation shall be conducted during validation)
1、GMP发展简史
1. Brief history of GMP development
2、GMP的实施与政府的相关政策
2. Implementation of GMP and relevant government policies
3、GMP软件体系的结构和内容、GMP文件的编写和管理知识
3. Structure and content of GMP software system, compilation and management knowledge of GMP documents
4、人员培训的要求、方法和事例介绍
4. Requirements, methods and examples of personnel training
5、验证的管理和文件化过程
5. Management and documentation of validation
6、《规范》及GMP检查实施细则的培训
6. Training on code and GMP inspection implementation rules
7、各个管理体系的培训
7. Training of each management system
8、迎检注意事项的培训
8. Training on inspection precautions
9、组织企业技术人员修订文件，咨询方与企业一对一指导
9. Organize the technical personnel of the enterprise to revise the documents, and provide one-to-one guidance between the consultant and the enterprise
（六）、软件和硬件建设的实施
（6） Implementation of software and hardware construction
1、企业按照咨询公司的意见进行厂房改造
1. The enterprise carries out plant reconstruction according to the opinions of the consulting company
2、企业技术人员和操作人员结合本企业的实际情况进行文件的修订和再学习
2. The technical personnel and operators of the enterprise revise and relearn the documents in combination with the actual situation of the enterprise
（七）、软件硬件的纠偏和验证的准备
（7） Preparation for correction and verification of software and hardware
1、咨询方在建设过程中根据硬件的实际情况进行纠偏，进行现场指导
1. The consultant shall rectify the deviation and provide on-site guidance according to the actual situation of the hardware during the construction
2、编制全公司验证计划
2. Prepare company wide validation plan
3、由咨询方提供企业验证方案样本，由企业编制本单位的验证方案，由咨询方负责审核把关
3. The consultant shall provide samples of the enterprise's verification scheme, the enterprise shall prepare its own verification scheme, and the consultant shall be responsible for reviewing and checking
4、设备验证知识培训
4. Equipment verification knowledge training
5、工艺验证知识培训
5. Process validation knowledge training
6、清洁验证知识培训
6. Cleaning verification knowledge training
（八）、软件硬件的磨合及试运行
（8） Running in and commissioning of software and hardware
1、GMP硬件改造完成后生产现场的准备及布置
1. Preparation and layout of production site after GMP hardware transformation
2、指导设备验证工作
2. Guide equipment verification
3、指导公用工程验证工作
3. Guide the verification of utilities
4、指导工艺验证工作
4. Guide process validation
5、GMP文件体系的审定和运行
5. Validation and operation of GMP document system
6、现场运行的指导，包括各种标志的管理
6. Guidance on site operation, including management of various signs
7、企业进行自检，不合格项目进行整改
7. The enterprise conducts self inspection and rectifies unqualified items
（九）、GMP认证模拟检查
（9） . GMP certification simulation inspection
1、指导企业完成GMP申报资料的编写并由咨询方进行审核把关
1. Guide the enterprise to complete the preparation of GMP application materials, and the consultant shall audit and check them
2、由咨询公司组织进行模拟检查
2. Simulated inspection organized by the consulting company
3、对不合格项目进行整改，保持质量体系的运行
3. Rectify the non-conforming items and maintain the operation of the quality system
以上就是为大家介绍的GMP咨询公司https://www.fmkgmp.com有关的详细的介绍,希望对您有所帮助.如果您有什么疑问的话,欢迎联系我们.我们将以专业的态度,为您提供服务.
The above is the GMP consulting company introduced to you https://www.fmkgmp.com I hope that the detailed introduction to the will be helpful to you If you have any questions, please contact us We will provide you with professional service