Jiangsu Province Laboratory Animal License Annual Inspection Report

Unit Name

( Legal entity )

Shengshi Taikang Biopharmaceutical Technology (Suzhou) Co., Ltd.

Legal

Representative

Ding Juping

Unit Address

Suzhou Industrial Park, Bio-Nano Park Phase I, Xinghu Street C11-101, 102

Unit Website

https://www.cgenetech.com.cn/

Laboratory animals

The competent authority of the unit

Department of Biology

Department Head and Landline Phone

Lu Qin 051262956960

Laboratory animals

Regarding qualifications

China

Is it located within the park premises? (Such as the science park, high-tech zone, incubator, etc.)

No

Does the organization qualify as a high-tech enterprise?

No

Management Compliance Status

Is there any violation of research integrity?

No

Is there any violation of safe production practices?

No

Whether you have been listed on the credit blacklist by the relevant authorities

No

Are there any violations of the "Implementation Measures for Strengthening In-Process and Post-Event Supervision of Administrative Licensing for Laboratory Animals (Revised Edition)"?

No                                 

Mid- and Post-Event Supervision

Content Self-Review Status

Changes to License Basic Information

( 1) Promptly update the organization’s registered information, such as the unit name, legal representative, and facility address.

Yes, the specific change is: The company name has been changed to Shengshi Taikang Biomedical Technology (Suzhou) Co., Ltd.

( 2) Promptly update permit information such as facility environment, animal species, and facility area.

No changes this year.

( 3) Apply for license renewal by the specified deadline.

No continuation this year

Implementation Status of Basic Systems

( 1) Develop management systems and standard operating procedures, and revise them promptly.

Is

( 2) All original records related to the production of laboratory animals are complete (including personnel entry/exit, disinfection procedures, temperature and humidity levels, pressure differentials, strain preservation, breeding activities, and operation of hardware equipment).

Is

( 3) Develop a biosafety emergency response plan, equip essential emergency supplies, and publicly display contact information for reporting incidents involving laboratory animals as well as emergency procedures in prominent locations.

Is

Management Team and Staffing Information

( 1) Promptly update the head of the experimental animal management and ethics committee.

There were no changes that year.

( 2) Promptly update the biosafety emergency contact person and facility contact.

There were no changes that year.

Facility Usage and Environmental Quality Control Status

( 1) Promptly file a record if facilities are suspended from use or have not conducted animal experimentation activities for more than 6 months.

Not involved

( 2) Regular environmental testing of the laboratory animal facilities, with complete original records for all relevant tests.

Is

Animal Quality, Control, and Welfare Assurance Measures

( 1) Regular quality inspections of animals, with complete original records of relevant tests (limited to production facilities only).

Not involved

( 2) Harmlessly dispose of animal carcasses and waste materials, with complete documentation.

Is

( 3) Promptly enter data into the national and provincial laboratory animal management systems.

Is

( 4) Conduct ethical reviews of laboratory animal welfare in a standardized manner.

Is

Other situations

( 1) Produce, sell, purchase, and use laboratory animals with valid quality certificates in accordance with laws and regulations.

Is

( 2) Applications for science and technology awards and participation in science and technology program projects must adhere to standards for laboratory animal research and ensure complete documentation.

Is

( 3) Are there any instances of outsourcing or subcontracting for animal testing?

No

( 4) Do the quality of laboratory animal cage equipment meet relevant standards? Are the frames stable and secure, with smooth, even surfaces free of cracks or leaks?

Is

Biological Safety Management Status

Shengshi Taikang has established a comprehensive biosafety management system and conducts regular training sessions for relevant personnel. Emergency response plans have been put in place, along with ongoing biosafety training and emergency drills. The company promptly updates the contact persons responsible for reporting biosafety emergency plans. Under the supervision and guidance of the company's safety supervisors, Shengshi Taikang actively promotes biosafety initiatives to proactively prevent potential incidents and ensure zero safety-related accidents.

Laboratory animal personnel

Personnel

Total

4 people

Categorized by nature

(People)

Technical personnel

Management personnel

Animal caretakers

Veterinarian

3

1

1

1

Categorized by educational level

(People)

Doctor

Master's degree

Bachelor

Junior college

0

2

1

1

Professionals participate in skills training and continuing education (people (per time)

4

Employee Health Checkups (Persons)

4

Level of innovation

Undertake

Government

Scientific research

Project

Conducting scientific research using laboratory animals

Project

Apply at the provincial level or above 0 Item

Experimental Animal Research Project

Apply at the provincial level or above 0 Item

Source

Quantity

(Item)

Funding

Funding

(Ten thousand yuan)

Source

Quantity

(Item)

Funding

Funding

(Ten thousand yuan)

Country

0

0.00

Country

0

0.00

Provincial

0

0.00

Provincial

0

0.00

City-level

0

0.00

City-level

0

0.00

Other

0

0.00

Other

0

0.00

Total

0

0

Total

0

0

Experiment

Animals

Related

Award-winning

Situation

Award Name

Issuing Department

Award Level

None

None

None

Experiment

Animals

Related

Standard

Develop

Situation

Application 0 Item

Application Standard Name

Types of standards (National Standard, Local Standard, Industry Standard, Enterprise Standard)

Project Approval Department

None

None

None

Project Approval 0 Item

Project Approval Standard Name

Types of standards (National Standard, Local Standard, Industry Standard, Enterprise Standard)

Project Approval Department

None

None

None

Experiment

Animals

Related

Paper

Situation

International 0 Article

Domestic 0 Article

Representative Paper Title

(No more than 3 articles)

Publication Venue

First author

None

None

None

None

None

None

None

None

None

This year, significant achievements have been made in research or industry related to laboratory animals, with a maximum of 3 items, each under 500 words

None

License-issuing entity

Annual Work Summary

( Within 1000 words (additional pages may be attached).

Mainly includes: 1) The unit’s management of laboratory animals (including its management system, institutional framework, safety protocols, ethical reviews, as well as financial investment and supporting measures); 2) The annual construction and operational status of the laboratory animal facility, along with its role in supporting the development of the unit or the broader industry; 3) Any existing challenges and relevant recommendations. Shengshi Taikang Laboratory Animal Facility is located in Suzhou Free Trade Zone and falls under the jurisdiction of the Department of Biology. Its primary function is to support the breeding of research-grade laboratory animals for our company. The Department of Biology and the Quality Assurance Division regularly review and promptly update the facility’s animal-related management policies. To ensure the facility operates smoothly, routine inspections of the animal housing environment, sterilization quality checks for pressure vessels, and equipment calibration are conducted as scheduled. Additionally, the facility collaborates only with qualified suppliers to procure compliant laboratory animals, while ensuring proper disposal of animal carcasses, medical waste, and used bedding materials through safe and environmentally sound processes. For researchers, comprehensive pre-employment training is provided, and ongoing skill development programs are implemented to enhance technical expertise and standardize operational practices, thereby fostering a strong awareness of both animal welfare ethics and biosafety principles. In 2023, despite a decline in the number of research projects—and consequently, a reduction in the overall use of laboratory animals—the facility’s management remained committed to maintaining compliance with barrier facility standards and reinforcing oversight of both researchers and technical staff, ensuring uninterrupted operations.

License-issuing entity

Opinion

The information provided above is accurate.

Official Seal:

Year Month Day

Science and Technology Bureau of the Prefecture-Level City

Annual Inspection Feedback

Official Seal:

Year Month Day