thermo scientific

Zhongxi Sunve Automates and Enhances Pharmaceutical Quality Management

CASE STUDY Thermo Scientific SampleManager LIMS software

OverviewAs a company directly owned by Shanghai Pharma, Shanghai

Zhongxi Sunve Pharmaceutical Co. Ltd. (“Zhongxi Sunve”) was

created in June 2010 following the merge of two giants, the

century-old former Shanghai Zhongxi Pharmaceutical Co. Ltd. and

Shanghai Sunve Pharmaceutical Co. Ltd., one of China’s leading

pharmaceutical companies. Zhongxi Sunve bears the mission to

develop specialty APIs and associated medicines for Shanghai

Pharma.

The company has three production facilities. The Xinghuo facility

is compliant with domestic and international cGMP and EHS

standards, is used for mass production of specialty APIs and as

a research incubator. The Waigang facility produces medicines

compliant with domestic GMP standards, and the Jinhe facility

produces plant-based anti-carcinogenic APIs in compliance with

domestic and international cGMPs, with future plans to develop

anti-carcinogenic drugs. The Xinghuo and Waigan facilities also

house QC laboratories with more than 100 testers. The company

focuses on developing treatments for psychiatric, neurological,

rheumatic immune, tumorous and other conditions, and boasts

key competitive medicines and influential brands for psycho-

neurological and rheumatic immune treatments. Zhongxi Sunve has

received approvals for 110 medicines, including 29 APIs and 82

drug products.

Business ChallengesIn 2016, Zhongxi Sunve stressed the need to invest in digital

systems for its laboratories. In doing so, the company introduced

the concept of “smart medicine” which incorporated digitalization,

networking, sustainability and environmental considerations.

This was intended to drive informatics in production and quality

management, and construct an intelligent manufacturing system to

achieve “leanness, automation, information readiness, smartness

and greenness”. The purpose was to ensure successful business

growth, build smart and “green” factories and develop high-end

manufacturing facilities for quality generic medicines. In addition,

the company wanted to implement the current cGMP management

standards across the organization, provide continuous training for

its employees, strengthen compliance awareness and constantly

improve product and service quality. The bottom line was to

produce medicines that comply with international pharmacopoeia,

meet personalized customer needs, and to continue as a strategic

supplier for global pharmaceutical companies.

Historically, Zhongxi Sunve mainly relied on manual, paper-based

processes including manually transcribed testing data, paper-based

data storage and transmission, as well as manual task assignment

and progress tracking. This led to vast quantities of error-prone

manual transcription work for laboratory workers. It also caused

problems like complex paperwork storage, difficulties in searching

required data quickly and delays in processes through a lack of

automation. All this made it very difficult for laboratory managers to

do their jobs effectively.

The Laboratory Information Management System (LIMS) was

introduced as an essential choice for business growth that

addressed data storage complexities, inability to quickly locate data,

high QM costs and high compliance risks.

SolutionZhongxi Sunve decided to purchase a LIMS for several reasons,

Firstly it needed to track and trace data quickly to make its

laboratories more compliant. Secondly, it wanted to quantitatively

assess all laboratory resources through a digital system to achieve

effective resource management. Finally, it wanted to access

and statistically analyze QC data in real time to enable scientific

management of the data, and achieve a paperless laboratory. The

decision makers at Zhongxi Sunve selected Thermo Scientific™

SampleManager LIMS™ software due to Thermo Fisher Scientific

being a well-known global company with a great brand image

and reputation in the industry. Another significant reason was that

Thermo Fisher had experience in serving the industry globally

for more than 40 years and offered fully functional, flexible and

configurable solutions compliant with regulations such as FDA 21

CFR Part 11. Moreover, its 24/7 global service network ensures that

customers are able to access professional advice from domestic

and international teams of technical experts at any time. The ability

to remain a thought leader and provide sustainable services is an

additional strength of the organization.

Furthermore, Thermo Scientific™ SampleManager™ LIMS Software

could be implemented in more than one environment. It is a

scalable and flexible solution which can be configured to suit

different requirements and workflows, especially in the case of

Zhongxi Sunve, a company with laboratories at multiple locations

and many functional groups. SampleManager LIMS software is

easily integrated with other apps and instruments inside and outside

of the laboratories, and provides a standard user interface to help

Zhongxi Sunve easily implement standardized processes across the

laboratory network.

ImplementationSampleManager LIMS software was deployed centrally across

Zhongxi Sunve using virtual platform technologies, with the

server located at the computer center of the Xinghuo facility. The

system covers management of the entire production sample

process including registration, collection, reception, distribution,

analysis, result entry/review and report preparation/review/sign off.

SampleManager LIMS software was also fully integrated with the

Manufacturing Execution System (MES), and managed stability

inspection, environmental monitoring, personnel, instrumentation,

methods, standards, reagent inventory, system security, data query

and analysis.

The LIMS was implemented in two phases. Phase I focused on

developing sample life cycle management and all elements of

laboratory management. Phase II will cover electronic SOPs and

instrument connectivity.

Before phase I of the implementation, the service team at Thermo

Fisher Scientific worked with Zhongxi Sunve to complete a full range

of preparatory tasks. They defined all business processes, such as

sample testing, supplies/reagents, instruments management and

specific coding rules. A project execution team was formed as well

as ongoing software and hardware support resources, including

system and IT administrators.

To start the implementation, Thermo Fisher’s service team held

several meetings with Quality Directors, QC Managers and QC

laboratory analysts at Zhongxi Sunve’s Xinghuo and Waigang

facilities to confirm project plans, arrange training and analyze and

verify requirements. This was followed by system configuration

and design, “double-track” operation, and UAT confirmation and

validation programs. During a trial period, more than 150 users

processed 862 batches of finished products, 600 batches of

raw/auxiliary materials, 1748 batches of intermediates, purified

water and samples of sedimentary and planktonic bacteria in

environmental monitoring. There were also 4981 records of entry for

reagents and 1966 for reference materials. Following this successful

trial, Zhongxi Sunve went live with SampleManager LIMS software.

The reputation of Thermo Fisher Scientific as a close partner of its

customers and the company’s powerful technical support provided

reassurance for Zhongxi Sunve. During the implementation, Zhongxi

Sunve was able to interact with dedicated representatives from

Thermo Fisher Scientific, which helped keep the implementation

process as simple as possible. Thermo Fisher provided a full range

of user training, business analysis, system setup and configuration,

technical support and coaching, validation services and operational

support. In addition, Zhongxi Sunve had the assurance of follow-

up support from Thermo Fisher to respond quickly to any potential

issues.

Benefits of Using SampleManager LIMS softwareAs a complete laboratory information management system,

SampleManager LIMS software eliminated the need to

select products from various vendors and integrate different

technologies. There was no technical barrier and the cost of

technical support was reduced. After the system was put into

use, Zhongxi Sunve reduced repetitive manual work significantly,

and improved efficiency in information transmission and sharing,

in task workflows, data analysis and application as well as quality

management.

The system enabled cost reduction through saving resources

associated with paper-based recording, printing, storage and

aggregation. Zhongxi Sunve were also able to optimize data

sharing, improve efficiencies, reduce costs and avoid human errors

while ensuring compliance.

Follow-up StepsSampleManager LIMS software supports the addition of new

business applications in line with business growth, such as new

product lines, analyzing methods, testing standards, statements,

workflows, personnel, instruments and devices. It can also be

configured and scaled up to meet new business needs.

The LIMS was integrated with the MES at its production facilities

and achieved the goal of sample life cycle management. In Phase II

of the implementation, further systems will be integrated with LIMS

including ERP, Thermo Scientific™ Chromeleon™ Chromatography

Data System (CDS) software, the training system and the CAPA

system. The company will also implement the Laboratory Execution

System (LES) and instrument data collection capability within

SampleManager LIMS software. Thermo Fisher will continue to

provide technical support and services for system application and

daily optimization, security and computer-based system validation.

By incorporating the Laboratory Execution System (LES), instrument

data collection and Chromeleon CDS software, Zhongxi Sunve will

achieve further paperless laboratory management and automation,

lower management costs and ensure continuous improvement and

mitigate compliance risks to bring its quality management process

to a new level.

Scope of Phase I Implementation

Sample Life Cycle Management All-factor Management ofLaboratory Tests

System SecurityManagement

Additional ManagementQuality Control & ManagementStability ManagementEnvironmental

Monitoring Management Sample statusSample tracingAuditing & trackingSQC analysisOOS/OOT

Stability solutionsStability processesStability reports

Sampling locationsSampling plansMonitoring analysisData/reports

PasswordRoleAuthorityE-signatureAudit tracing

Workflow configurationAlerts managementMessage notification

Data Access & AnalysisSearching dataAccessing statementsExporting dataVisualization

Personnel managementInstruments managementReagents & standard materials managementTesting methods managementTesting items managementTesting standards managementTesting templates management

Requesting samplesCollecting samplesReceiving (splitting/retaining samples)Laboratory analysisEntering resultsReviewing dataCOA/Reporting(Preparation/review/approval)Managing retained samples (expiry alerts/location/destruction etc.)

ConclusionSampleManager LIMS software leads the industry in terms of scale, flexibility, configurability and user friendliness. Thanks to its patented workflow technology, the system is able to map laboratory workflows through a flexible and intuitive interface. The flexibility of the LIMS and its ability to process huge amounts of data supports Zhongxi Sunve’s growing business needs. With its built-in instrument integration, SampleManager LIMS software improves productivity from the outset by supporting all aspects of the sample testing process and the tracking of relevant quality elements, effectively reducing repetitive manual tasks and human errors, ensuring data integrity, strengthening QM rules and standards. The flexibility of the system allows users to connect with other systems, such as the MES.

The LIMS was designed to meet the evolving needs of today’s laboratories and lay the groundwork for storing and processing vast quantities of data. Based on its reliable performance, adaptability and easily configurable features, SampleManager LIMS software is the laboratory solution of choice for many organizations around the globe.

Find out more at thermofisher.com/digitalscienceFor Research Use Only. Not for use in diagnostic procedures. © 2020 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. CS80216-EN0320

Thermo Fisher’s officialWechat account

Thermo Fisher’s official website