zhongxi sunve automates and enhances pharmaceutical...
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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
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