Medical GMP cleanroom solution: Huajianjing assists enterprises in obtaining dual certification from FDA and EU GMP

Huajian Jing作为一家Specializing inPharmaceuticalCleanroomSolutions的供应商，为Pharmaceutical企业Provide全面的 GMP CleanroomSolution，助力企业Pass FDA 与欧盟 GMP 双重Certification。以下为该Solution的主要Content及要点：

1、 Principles of cleanroom design

1. Adhere to relevant national and international regulations and standards: Ensure that the design meets the strict requirements of national drug regulatory authorities and international standards.
2. Reasonable spatial layout: Based on production processes and product characteristics, the production space should be reasonably arranged to reduce the risk of cross contamination.
3. Air cleanliness control: By using an air purification system, ensure that the air quality in the clean room reaches the corresponding level.

2、 GMP cleanroom solution

1. Pre consultation and evaluation: Based on the needs and production characteristics of the enterprise, provide professional consultation and evaluation services, and develop suitable clean room construction plans.
2. Space layout design: Follow the production process and cleanliness requirements to design a reasonable space layout.
3. Air purification system: Select efficient air filtration equipment to ensure stable air quality and standard cleanliness in the clean room.
4. Equipment selection and installation: Provide suitable production equipment and auxiliary equipment selection suggestions, and be responsible for equipment installation and commissioning.
5. Cleanroom decoration and construction: Carry out decoration and construction according to the design plan to ensure that the quality of the cleanroom decoration meets the requirements.
6. Validation and testing: Conduct cleanroom performance validation, equipment validation, and product testing to ensure that all indicators meet GMP requirements.

3、 Assist enterprises in obtaining dual certification from FDA and EU GMP

1. Provide professional GMP training: Conduct GMP training for enterprise employees to enhance their understanding and execution ability of GMP.
2. Assist enterprises in establishing a quality management system: Help enterprises establish a sound quality management system to ensure that the production process meets GMP requirements.
3. Provide customized solutions: Based on the characteristics and needs of the enterprise, provide customized clean room construction plans and technical support.
4. Cooperation with domestic and foreign certification agencies: Establish cooperative relationships with certification agencies such as FDA and the European Medicines Agency to provide certification consulting and coaching services for enterprises.
5. Regular maintenance and inspection: Regularly maintain and inspect the clean room to ensure that the production environment continues to meet GMP requirements.

IV. Summary

Huajian JingPassProvide全面的 GMP CleanroomSolution和Professional TechnologySupport，HelpPharmaceutical企业AchieveHigh-Efficiency、Safety的生产环境，并Pass FDA 与欧盟 GMP 双重Certification。此Solution关注于关键细节、流程及验证步骤的规范和实施，旨在为企业ProvideReliable的保障和长期的Support。同时，企业应积极配合并遵循相关法规和标准，不断提升自身的管理水平和生产能力，以Achieve持续的合规性和竞争力。