1. Basic project situation
(I) Project name: Immune cell preparation and transformation platform clean factory confirmation service procurement.
(2) Project location: Jinfeng Laboratory.
(III) Procurement method: inquiry and purchase.
(IV) Procurement content: Immune cell preparation and transformation platform clean air conditioning system, laboratory and clean delivery window confirmation service.
(V) Total project limit:130000Yuan, the total price of the quotation shall not be higher than the limit price.
(VI) The quotation includes all tools and equipment costs, taxes, freight, testing costs, materials costs, travel costs, accommodation costs, labor costs, etc., and the total cost is included in the budget amount.
2. Supplier qualification requirements
(1) Qualification conditions for Article 22 of the Government Procurement Law of the People's Republic of China:
1. Have the ability to bear civil liability independently;
2. Have good business reputation and a sound financial accounting system;
3. Have the equipment and professional technical capabilities necessary to perform the contract;
4. Have a good record of paying taxes and social security funds in accordance with the law;
5. Within three years before participating in government procurement activities, there were no major illegal records in business activities;
6. Other conditions stipulated by laws and administrative regulations.
7. Provide corporate credit information disclosure report (paper report with watermark).
Note: Article 1 requires a business license, organization code certificate, tax registration certificate or legal person certificate of public institution. Only a business license is provided if the three certificates are integrated.； See the statement for details of paragraphs 2-6.
(2) Suppliers should have complete qualifications, have independent legal person qualifications, and must hold a legal person business license within the valid period, and the business scope clearly includes the service scope such as "consultation services" or "technical services".
3. Other requirements
(1) This service project is a "turnkey" project, and the supplier's services include assisting in rectification until it passes a third-party GMP audit compliance inspection.
(II) Technical requirements
| Serial number | Require | Necessary or expected |
Overall requirements | ||
1. | The supplier is responsible for ensuring that the confirmation progress is implemented in accordance with the confirmation master plan and implementing daily + weekly report management. A progress deviation report form is formed every week. | Required |
2. | Suppliers should have cases of independently completing large-scale confirmed projects, and should have consulting service contracts of more than 200,000, and the number should be no less than 1. (Requires a proof of project double-chapter contract) | Required |
3. | The project manager shall have a master's degree or above, a construction engineer certificate of level 2 or above in mechanical and electrical installation engineering, and project experience in project management confirmation of the entire factory. (Providing certificates and supporting documents) | Required |
4. | The consulting company shall provide no less than 3 project team members according to needs, with at least 5 years of work experience, and must cover the key aspects required to be confirmed by the new biopharmaceutical factory, such as public systems, factories, computerized systems, production equipment, etc. It is required to be confirmed by A before dispatch. | Required |
5. | Provide a complete set of confirmation instruments and reagents and consumables. | Required |
6. | During the project implementation and subsequent maintenance process, problems found should be responded to within 2 hours, arrive at the site within 24 hours, and the best solution should be proposed until it is resolved. | Required |
7. | Specific implementation plans can be formulated before the project is implemented. | Required |
8. | Organize platform management technicians to conduct at least 3 on-site GMP training sessions at the right time. | Required |
Air conditioning system/laboratory confirmation requirements | ||
9. | Organize the completion information of the air conditioning system and laboratory, and assist the construction unit in making rectifications until the requirements are met. | Required |
10. | The service scope includes URS, SRA, DQ, IQ, OQ, PQ of air conditioning systems and laboratories. | Required |
11. | URS: Based on the customer's completion information and on-site conditions, we are responsible for the drafting and revision of the URS for 6 clean HVACs and 3 clean areas (detection area, virus area and cell preparation area). | Required |
12. | SRA: According to the 2019 C&Q Guide, implement system risk assessment for each system, identify risk points, analyze the level of risk, probability of occurrence, detectability and control measures, and form a report. | Required |
13. | Clean air conditioning system IQ: Responsible for the drafting, implementation and reporting of the clean air conditioning system IQ plan. IQ content should include but not be limited to: Confirmation of technical parameters of air conditioning system, instrument verification and confirmation, confirmation of installation of air conditioning system equipment and pipelines, confirmation of high-efficiency filters in junior and middle schools in air conditioning system, confirmation of air duct installation, confirmation of integrity of high-efficiency filters, etc. | Required |
14. | Clean area IQ: Responsible for the drafting, implementation and reporting of IQ plans. IQ content should include but not be limited to: Maintenance structure confirmation, water supply and drainage installation confirmation, ground and equipment installation confirmation, electrical and lighting confirmation, etc. | Required |
15. | Clean air conditioning system OQ: Responsible for drafting, implementing and sorting out reports of OQ plans. OQ content should include but not be limited to: Air conditioning system control function confirmation, equipment operation status, alarm function, etc. | Required |
16. | Clean area OQ: Responsible for the drafting, implementation and report sorting of the laboratory clean area OQ plan. OQ content should include but not be limited to: Confirm the air volume and ventilation times in each room, temperature and humidity confirmation, illuminance confirmation, noise confirmation, high-efficiency filter air volume and wind speed confirmation, pressure gradient confirmation, etc. | Required |
17. | PQ: Air conditioning system and laboratory PQ strategy: Sanjing, including at least the following test content: | Required |
18. | Refer to the Regulations Guide: GB/T16292-2010 Test method for suspended particles in clean room (zone) of pharmaceutical industry, 2010 ISO 14698 Clean Room and Related Controlled Environments-Biopollution Control, 2003 GB 50346-2011 Technical specifications for building biosafety laboratory GB 19489-2019 General requirements for laboratory biosafety | Required |
Clean transfer window confirmation requirements | ||
19. | Responsible for collecting and organizing relevant information about clean transfer window equipment with equipment manufacturers and customers | Required |
20. | URS, SRA, IQ, OQ of 16 clean transfer windows. | Required |
21. | URS: Draft and revise the URS based on the customer's equipment information, including 16 clean transfer windows. | Required |
22. | SRA: According to the 2019 version of the C&Q guide, implement risk assessment of each clean transmission window, identify risk points, analyze the risk level, probability of occurrence and detectability and control measures, and form a report. | Required |
23. | IQ: Drafting, implementation and report sorting of the IQ plan for clean transfer window. IQ content should include but not be limited to: Confirmation of technical documents, confirmation of installation of equipment main body, confirmation of installation of equipment main components, confirmation of installation of public systems, confirmation of instrument calibration, confirmation of installation of high-efficiency filters, confirmation of spare parts, etc. | Required |
24. | OQ: Drafting, implementation and report sorting of OQ plans for clean transfer windows. The content of OQ should include but is not limited to: control panel function confirmation, wind speed test, high-efficiency filter pressure difference confirmation, airflow tissue form confirmation, self-purification time confirmation, noise test, suspended particle test, ultraviolet lamp illuminance test, microbial test, ultraviolet lamp illuminance intensity test, etc. | Required |
The rooms and area information of the laboratory clean area are as follows:
| Room and area information | |||||
Cell area | Virus area | Test area | |||
Room name | Room area (m2） | Room name | Room area (m2） | Room name | Room area (m2） |
First update | 4.42 | One update 1 | 3.65 | Cleaning room | 14.13 |
Sterile underwear | 4.29 | One update 2 | 3.05 | Preparation room | 11.54 |
Sterile outerwear | 3.63 | Clothes room | 3.60 | One update room 1 | 2.1 |
Air lock room 1 | 5.27 | Air lock room 1 | 3.46 | Second update room 1 | 1.67 |
Refund update | 3.74 | Refund update | 3.82 | Buffer room 1 | 1.99 |
Air lock room 2 | 3.91 | Sterile underwear | 3.01 | Positive room | 18.16 |
Preparation room 5 | 13.68 | Sterile outerwear | 2.89 | Endotoxin chamber | 11.54 |
Air lock room 3 | 3.68 | Air lock room 2 | 4.26 | Preparation room | 19.66 |
Preparation room 4 | 19.98 | Cleaning room | 12.18 | Culture room | 9.98 |
Air lock room 4 | 4.46 | Sterilization room | 5.78 | One update room 2 | 1.55 |
Preparation room 3 | 16.05 | Cleaning utensil storage room | 5.91 | Second update room 2 | 1.44 |
Air lock room 5 | 3.91 | Exit room | 3.22 | Buffer room 2 | 1.52 |
Preparation room 2 | 14.07 | Virus filtering compartment | 13.05 | One update room 3 | 1.55 |
Air lock room 6 | 3.91 | Air lock room 3 | 3.52 | Second update room 3 | 1.44 |
Preparation room 1 | 15.63 | Virus purification | 12.52 | Buffer room 3 | 1.52 |
Exit room | 4.72 | Air lock room 4 | 2.89 | Sterile room | 14.60 |
Cleaning utensil storage room | 10.82 | Virus Preparation Room | 15.27 | Limit Room | 13.33 |
Private room | 4.34 | Virus treatment room | 18.51 | Immunohistochemistry room | 16.38 |
Outsourcing room | 7.91 | Receiving room | 5.63 | Instrument room | 19.21 |
Take off the private room | 3.48 | Cell bank | 23.49 | Sample room | 7.89 |
First update | 3.48 | Sterilization room | 4.68 | High-temperature room | 7.19 |
Clothes room | 2.96 | Cell culture room | 9.82 | Physical and Chemical Testing Room | 27.56 |
Air lock room 7 | 2.23 | Virus preparation area walkway | 27.27 | Balance room | 6.81 |
Cleaning room | 14.66 | Standard liquid chamber | 6.51 | ||
Immune cell preparation walkway | 50.75 | ||||
Note: The final room information shall be subject to the completion drawings, and the drawings shall not be made public during the procurement process. | |||||
(III) Acceptance and delivery
1. All work carried out by the supplier should ensure that the requirements of NMPA, EU, WHO, FDA/GMP are met. The implementation process is based on the relevant requirements of ISPE Baseline "Commissioning & Qualification". The commissioning and confirmation of engineering equipment should be based on the relevant requirements of ISPE GEP (Good Engineering Practice).
2. Suppliers shall strictly protect all confidentiality involving the purchaser and enter into a confidentiality agreement with the purchaser.
3. Any plans, standards and documents provided by the supplier shall be approved or approved by the quality manager of the Purchaser or other management and technical personnel entrusted by him, other relevant stakeholders of the Purchaser, and technical consultants hired by the Purchaser.
4. The supplier ensures that the real data is recorded and that the real problem is reflected (when confirming the service company's response, it is necessary to describe in detail how to ensure the data integrity during the certification process).
5. All personnel of the supplier must communicate with the purchaser and sign and confirm before entering/departing the site. The changes in personnel will not have a substantial impact on the project progress.
6. Confirm that the samples (petri dishes, pharmaceutical water samples, etc.) can be tested by a third-party company audited by the service provider and qualified. The audit report needs to be provided to the laboratory.
7. Suppliers provide confirmation instruments, consumables and culture laboratories. Such as petri dishes, biological indicators, preparation of water intake tools, culture chambers, etc. Confirmation of the consumables brand must be audited by a qualified supplier.
8. Provide confirmation plans, confirmation services and confirmation reports that meet the satisfaction of the purchaser. Delivery within 25 calendar days from the date of signing the contract. All documents should be provided with electronic templates, electronic version plans and written printed version plans at the same time, and will be accepted.
9. The ownership of all data, records, documents, etc. generated during the service process belongs to Party A and the supplier shall not use it other than others.
(IV) After-sales service
1. Service term: From the date of signing of the contract to the end of passing the third-party audit compliance report； The latest end time of the contract shall not exceed six months from the date of project acceptance.
2. During the inspection process of the regulatory department, it is clear that the responsible party is the defect of the service company and must be responsible for all subsequent rectification and guidance (including on-site rectification, rectification of relevant documents and plans, and preparation of rectification reports, etc.).
3. If an emergency technical problem occurs during the project execution, after the laboratory makes a service request, the service company should respond within 2 hours, arrive at the site within 24 hours, and propose the best solution until it is resolved.
(V) Warranty period
12 months from the date of project acceptance.
(VI) Time and method to raise objections to the service
According to the service plan, if the purchaser has objections to the confirmation of the service, the supplier shall resolve the issue within one working day from the date of the purchaser's objection and bear all costs incurred.
(VII) Payment settlement
Within 30 days of signing the contract, Party B will pay [60]% of the advance payment, Party B will complete the acceptance of the consultation service, and after passing the third-party audit compliance report, the remaining [40]% of the goods will be paid to Party B. The latest payment time for the final payment shall not exceed 6 months from the date of project acceptance.
4. Inquiry schedule
(I) Inquiry release time: 9:00 on July 30, 2025
(2) Inquiry deadline: 18:00 on August 1, 2025
The supplier shall send the quotation list and related attachments (need to be stamped with official seal and scanned in color) to the contact email kangqian@jflab.ac.cn before the inquiry deadline. Those who have not quoted before the inquiry deadline will be deemed to have automatically given up.
The decompression password of the compressed packet will be sent to the contact email kangqian@jflab.ac.cn within 30 minutes after the inquiry deadline. If the decompression password is not sent within 30 minutes, it will be deemed to be automatically given up.
Related attachments are as follows:
1. Copy of business license or proof documents of other organizational entities;
2. Certificate of qualification of legal representative (Appendix 1);
3. Authorization letter of the legal representative (Appendix 2);
4. Statement (Appendix 3);
5. Commitment letter (Appendix 4);
6. Quotation form (Appendix 5);
7. Relevant certificates and supporting documents.
5. Contact information
Contact person and contact information: Kangxi 15931898057
Contact address: No. 313, Gaoteng Avenue, Jiulongpo District, Chongqing
Number
023-68059903
Email：Jinfeng@jflab.ac.cn
Address:
No.313, Bella Road Chongqing High-tech Zone
Postal code: 401329
渝公网安备50009802002274