
Immune cell preparation and transformation platform purified water system and air conditioner upper computer system verification service project inquiry announcement
1. Basic project situation
(I) Project name: Immune cell preparation and transformation platform Purified water system and air conditioner upper computer system verification service procurement (second time).
(2) Project location: Jinfeng Laboratory.
(III) Procurement method: inquiry and purchase.
(IV) Procurement content: Immune cell preparation and transformation platform purified water system and air conditioner upper computer system verification service.
(V) Total project limit:189000Yuan, 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, and material costs, 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.
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; please refer to the statement for details in 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
(I) Acceptance and delivery
1. All work carried out by the supplier should ensure that the requirements of NMPA, EU, WHO, and FDA GMP are met. The implementation process is based on the relevant requirements of ISPE Baseline "Commissioning & Qualification". The verification of electronic and automation systems should refer to the requirements of GAMP5. The commissioning and verification of engineering equipment should refer to the relevant requirements of ISPE GEP (Good Engineering Practice).
2. The supplier shall strictly protect all confidentiality involving the purchaser and sign 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 the real problem is reflected (when verifying the response of the service company, it is necessary to describe in detail how to ensure the data integrity during the verification 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. Verification 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. The supplier provides verification instruments, consumables and culture laboratories. Such as petri dishes, biological indicators, preparation of water intake tools, culture chambers, etc. Verifying consumable brands must be audited by qualified suppliers.
8. Provide verification solutions, verification services and verification reports that meet the satisfaction of the demand party. Delivery within [30] days from the date of signing of the contract. All documents should also provide electronic templates, electronic version plans and written printed version plans.
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.
(II) After-sales service
1. Service period: The deadline for the completion of the third-party audit compliance report from the date of signing the contract to the end of the approval of the third-party audit; the latest end time for 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, propose the best solution, and follow up until it is resolved.
(III) Warranty period
6 months from the date of project acceptance.
(IV) Time and method to raise objections to the service
According to the service plan, if the purchaser has objections to this verification/test, the supplier shall resolve the issue within one working day from the date of the purchaser's objection and bear all costs incurred.
(V) 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: 12:00 on June 23, 2025
(2) Inquiry deadline: 12:00 on June 26, 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).
5. Service requirements list
Verification requirements for purified water preparation and distribution system | |
Serial number | Verification requirements |
1 | Range: PQ sampling + test. Purified water preparation system: 1 set, 1 set of distribution system, the number of purified water points: 8, of which 6 use points + 1 EDI + RO1, total 8, and 14-day sampling and testing were carried out. |
2 | Verified delivery items include: URS, SRA, FRA, DQ report, IQ plan, implementation and reporting, OQ plan, implementation and reporting, PQ plan, implementation and reporting |
3 | Refer to the Regulations Guide: |
4 | The purified water sampling strategy is to take samples at every point every day, and the testing items and standards are based on the 2025 edition of the Chinese Pharmacopoeia |
5 | The supplier is responsible for the reagents and consumables used in the PQ process of the purified water system. |
BMS system (air conditioner automatic control system verification) verification requirements | |
1 | Range: URS, VP, SRA, FRA, FAT, SAT, IQ, OQ, RTM, VSR. |
2 | Refer to the Regulations Guide: "Pharmaceutical Records and Data Management Requirements (Trial)" US Federal Regulations 21CFR Part 11: Electronic Records, Electronic Signatures WHO Computerized System Verification Guide ISPE GAMP5: Risk-based Compliance Methods for Computer Systems in GXP ASTM E2500 Guidelines for specification, design and verification of pharmaceutical and biopharmaceutical production systems and equipment |
3 | Cooperate with the BMS system manufacturer to debug the computer system, complete the FAT and SAT work, and form plans and reports |
6. Contact information
Contact person and contact information: Kangxi 15931898057
Contact address: No. 313, Gaoteng Avenue, Jiulongpo District, Chongqing
appendix:
Attachment 1: Certificate of Qualification of Legal Representative
Attachment 2: Authorization letter of the legal representative
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