# Tsingke Customer Quality Audit Highlights Manufacturing Systems and Quality Controls

- Link: https://www.thailand-business-news.com/pr-news/tsingke-customer-quality-audit-highlights-manufacturing-systems-and-quality-controls
- Published: 2026-10-14T21:19:00+07:00
- Author: PR Newswire

BEIJING, Oct. 14, 2026 /PRNewswire/ — As synthetic biology expands into new applications,
standardized manufacturing processes, reliable production data, and robust quality
management systems are becoming increasingly important. Tsingke recently hosted 
an on-site customer quality audit conducted by Sichuan Kelun-Biotech Biopharmaceutical
Co., Ltd. at its Chengdu manufacturing facility. The audit focused on four key areas:
raw material traceability, equipment lifecycle management, computerized systems 
and data integrity, and biological sample management.

[⌊Representatives from Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. inspect
manufacturing equipment and quality control workflows at Tsingke's Chengdu facility.⌉⌊
Representatives from Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. inspect manufacturing
equipment and quality control workflows at Tsingke's Chengdu facility.⌉[
Representatives
from Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. inspect manufacturing equipment
and quality control workflows at Tsingke’s Chengdu facility.

**Audit Assesses Key Quality Controls Across Manufacturing Operations**

**Raw Material Traceability:** Auditors reviewed material receipt and inventory 
records, certificates of analysis (COAs), and incoming material acceptance records.
They also examined forward and backward traceability procedures to verify the connections
between raw materials, manufacturing activities, finished products, and associated
production records.

**Equipment Lifecycle Management:** The audit covered equipment qualification records,
calibration certificates, routine maintenance records, and equipment status labeling.
Auditors paid particular attention to how equipment qualification, maintenance, 
and monitoring are managed throughout the equipment lifecycle.

**Data Integrity and Computerized Systems:**  Auditors reviewed validation documentation
for computerized systems and access control procedures for systems including Core-
System and U8 Cloud. They also examined data archiving, backup, and periodic review
procedures to assess the controls in place to support the integrity and availability
of production and quality data.

**Biological Sample Management:** The audit covered the full lifecycle of biological
sample management, including sample receipt, identification, storage, transfer, 
retention, and disposal.

Together, these areas illustrate how Tsingke integrates quality management requirements
into routine manufacturing procedures and operational controls.

**From Quality Management to Intelligent Manufacturing: Advancing "AI + Molecular
Manufacturing"**

As molecular manufacturing expands to serve a broader range of applications, maintaining
consistent quality and reliable production becomes increasingly important.

For Tsingke, standardized workflows, robust quality controls, and reliable production
data provide the foundation for its "AI + Molecular Manufacturing" strategy. These
capabilities create opportunities to apply artificial intelligence to production
analytics, process monitoring, and process optimization.

Building on this foundation, Tsingke’s **Gene Factory** model integrates molecular
manufacturing with digital technologies, aiming to coordinate and optimize operations
across the production process rather than focusing on individual steps in isolation.

The quality systems and operational controls reviewed during the audit reflect the
importance of standardized processes and reliable data in supporting more integrated,
digitally enabled manufacturing operations.

**Strengthening Capabilities for Scalable Molecular Manufacturing**

Looking ahead, Tsingke will continue to refine its manufacturing processes and quality
management systems while exploring opportunities to apply digital technologies and
artificial intelligence to molecular manufacturing. These efforts are aimed at improving
operational consistency, supporting manufacturing scalability, and strengthening
long-term customer partnerships.

**About Tsingke**

Beijing Tsingke Biotech Co., Ltd. is a biotechnology company providing comprehensive
solutions for research and therapeutic development. With expertise in molecular 
biology, genetics, and protein science, Tsingke offers custom DNA/RNA synthesis,
gene cloning, protein expression, antibody discovery, and viral vector packaging(
AAV, LV, AdV). Its ISO 13485–certified facilities and Class 100,000 cleanroom ensure
consistent quality and reliability. Backed by advanced automation and a global scientific
team, Tsingke accelerates innovation in drug discovery, functional genomics, and
genetic engineering—empowering researchers worldwide with cutting-edge biomanufacturing
solutions.

For news and updates, follow Tsingke Biotech on[ ](https://www.linkedin.com/company/tsingke-biotech)
[LinkedIn](https://www.linkedin.com/company/tsingke/).

Media Contact:
[market@tsingke.com.cn](https://www.thailand-business-news.com/pr-news/market@tsingke.com.cn)

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