Appendix I
Plant Master File
Sr. No Requirements Information
A GENERAL INFORMATION
I Brief information on Manufacturer:
the site (including Sinothinker Technology Co., Limited
name and address), Address:201,Bulding B2,Yijing Industrial City ,Tian Liao
relation to other sites Community ,
Yutang Street ,Guangming District ,Shenzhen ,China
Web: http://www.sxk8.com/
II Manufacturing License Number: YSYJXSCX No. 20081593
activities as licensed The People’s Republic of China Production License for Medical
by the Competent
Device Production Enterprises
Authorities
Company Name: Sinothinker Technology Co., Limited
Legal Representative: Yuan Youan
Issued By: Guangdong Food and Drug Administration (Seal)
Valid Till: May 9, 2021
Date of Issued: December 9, 2023
III Any other operations Manufacturer for Semi-auto Chemistry Analyzer
carried out on the site
IV Name and exact 1. Name of company, site address and mailing address (if
address of the site, different from site address)
including telephone, Sinothinker Technology Co., Limited
fax numbers, web site Address:201,Bulding B2,Yijing Industrial City ,Tian Liao
URL Community ,
and e-mail address Yutang Street ,Guangming District ,Shenzhen ,China
Web: http://www.sxk8.com/
Contact person:Yuan Youan
Email address: [email protected]
V Type of medical 1. Model: SK3002B
devices
handled on the site
and
information about
specifically toxic or
hazardous substances
handled, mentioning
the
way they are handled
and precautions taken
VI Short description of 1. Provide a map indicating the location of the site(s) and the
the surrounding area. Mark the site(s).
site (size, location and 2. Other activities on the site.
immediate
environment
and other activities on
the site)
VII Number of employees Area of No of No of
engaged in Operation Permanent/regular Contractual
Production, employees employees
Quality Control,
warehousing, and 1. Production 48 48
distribution 2. Quality
Control
3.Warehousing
4. Storage
5. Distribution
6. Technical &
Engineering
Support
Services
VIII Use of outside Manufacturer:
scientific, analytical Sinothinker Technology Co., Limited
or other technical Address:201,Bulding B2,Yijing Industrial City ,Tian Liao
assistance in relation Community ,
to Yutang Street ,Guangming District ,Shenzhen ,China
the design, Web: http://www.sxk8.com/
manufacture and
testing
IX Short description of The analyzer is carried out according to the provisions of GB
the 4793.1-2007, GB 4793.9-2013 and YY 0648-2008, and the
quality management results should meet the requirements of GB 4793.1-2007, GB
system of the 4793.9-2013 and YY 0648-2008.
company Electromagnetic compatibility shall be carried out according to
the provisions of gb/t 18268.1-2010 and gb/t 18268.26-2010,
and the results shall meet the requirements of gb/t 18268.1-2010
and gb/t 18268.26-2010
Signs and instructions :It shall meet the requirements of
gb/t29791.3
X Devices details Indonesia, Brazil, Sudan
registered with
foreign countries
XI brief description of PC
testing facility
B PERSONNEL
I Organization chart
showing the
arrangements for key
personnel
II Qualifications, Owner: Yuan Youan
experience and General manager: Yuan Youan
QC dept manager: Wang Zhengrong
responsibilities of key
personnel Finance dept manager: Wang Jun
Production dept manager: Zheng Huinian
III Outline of The person in charge of relevant departments shall arrange
arrangements for training after determining the training needs according to the
basic and in-service situation of employees.
training and how Installation training, QC training, maintenance training
records are The person in charge of relevant departments shall assess and
maintained give the training report
If the relevant assessment is unqualified, retraining is required
The training records are kept in the personnel department
IV Health requirements Personnel dept. is responsible for checking health of employees,
for personnel engaged organize regular hospital physical examination
in production There is a pre-employment medical examination
Employees are routinely checked from time to time depending
on the nature of their work
There is a system for reporting sickness or contact with sick
people before working in a critical area
There is a system of reporting back after illness?
Those are who work in clean areas (Grade A-D) subject to
additional monitoring
V Personnel hygiene There are suitable washing, changing and rest areas?
requirements, The clothing is suitable for the activity undertaken? Briefly
including describe the clothing
clothing There are clear instructions on how protective clothing should
be used and when it should be changed? External laundry used
C PREMISES AND FACILITIES
I Layout of premises Please see the “Plan of area”
with indication of
scale
II Nature of Comply with relevant Chinese national building standards
construction,
finishes/fixtures and
fittings
III Brief description of Window ventilation
ventilation systems.
More details should
be given for critical
areas with potential
risks of airborne
contamination
(including schematic
drawings of the
Systems).
Classification
of the rooms used for
the manufacture of
sterile products
should be mentioned
IV Special areas for the Please find in “Semi-auto chemistry analyzer
handling of highly toxic, Risk Management Report”
hazardous and
sensitizing materials
V Brief description of water Conform to national health standards
systems (schematic drawings
of the systems are desirable)
including sanitation
VI Maintenance Daily/weekly/monthly maintenance
(description of planned There are written procedures and contractual
preventive maintenance details for outside work
programmes for There are written procedures and suitable
premises and recording reporting forms for maintenance and servicing
system) Documents do record type/frequency of
service/checks, details of service, repairs
and modifications
The maintenance routines that could affect
medical device quality been clearly identified
The reports are made known to the users
D EQUIPMENT
I Brief description of major The instrument is made of aluminum parts, sheet
production and quality control metal parts and plastic parts
laboratories equipment (a list Designed for easy cleaning
of the equipment is required)
II Maintenance Engineers are responsible for maintenance and
(description of planned servicing
preventive maintenance There are written procedures and contractual
programmes and details for outside work
Recording system). Maintenance routines are which could affect
product quality clearly identified
Records are kept of
.type and frequency of service/check
.details of service repairs and modifications
Reports are made known to the users
III Qualification and calibration, QC dept check the qualification and validation
including the recording There is regular revalidation of critical
system. Arrangements for equipment
computerized systems
Validation.
E SANITATION
I Availability of written There are written procedures for cleaning and
specifications and specifications for cleaning agents and their
procedures for cleaning concentration for the method of cleaning and the
the manufacturing areas Frequency
and equipments Cleaning agents are changed from time to time
The cleaning procedures have been validated and
what was the method of evaluating the
effectiveness of cleaning
Cleaning methods are monitored routinely by
chemical and/or microbiological methods?
F PRODUCTION
I Brief description of Mental assemble→Fluid system assemble→
production operations Electricity assemble→QC test→FQC test→
using, wherever Package test→Delivery
possible, flow sheets
and charts specifying
important parameters
II Arrangements for the The following points had been addressed:
handling of starting 1. Control of manufacturing
materials, packaging Checks on key parameters during manufacture
materials, bulk and Records of key parameters
finished products, In-process checks
including sampling, Records of in-process checks
quarantine, release and Compliance with the Marketing Authorization
Storage. 2. Packing
Release of bulk, semi-finished products,
packing materials
Confirmation of identity and line clearance
checks
3. Quarantine and release of finished products;
Compliance with Marketing Authorization.
4. Explain the role of the Authorized Person(s).
III Arrangements for When there is QC issue, will arrange for
reprocessing or rework reprocessing or reworking batches of products
IV Arrangements for the
handling of rejected Rejected materials and products are clearly
materials and products labeled
They are stored separately in restricted, in
Rejected area
There is destruction recorded
V Brief description of Process validation policy
general policy for
process validation
VI Brief description of Applicable sterilization equipment, in line with
sterilization facility; national health standards
G QUALITY Assurance
I Description of the QC test:
Quality Control system The temperature accuracy should be ± 0.2 ℃,
and of the activities of and the temperature fluctuation should be ± 0.1
the Quality Control ℃
Department. Procedures Stability of absorbance: The change of
for the release of
finished products absorbance shall not be greater than 0.01.
Stray light shall not be greater than 0.3%
The repeatability of absorbance is expressed by
coefficient of variation, which should not be
greater than 1.5%.
H STORAGE
I Policy on the storage of Store in warehouse and package completely (use
medical device wooden or iron cases)
I DOCUMENTATION
I Arrangements for the Arranged by personnel department
preparation, revision and
distribution of necessary
documentation, including
storage of master documents
J MEDICAL DEVICE
COMPLAINS AND FIELD
SAFETY CONRRECTIVE
ACTION
I Arrangements for the handling Handled jointly by personnel department and
of complaints after-sales department
II Arrangements for the There is a written procedure which describes the
handling of field safety sequence of actions to follow including:-
corrective action a. Retrieval of distribution data;
b. Notification to customers;
c. Receipt/segregation/inspection of
returned medical devices;
d. Investigation/reporting of cause.
e. Reporting corrective action.
Personnel department and Production
department are responsible for coordinating
medical device field safety corrective actions
Personnel department and Production
department notifies the Competent Authority of
field Safety corrective actions
Canfield safety corrective actions is effected
below wholesale level
There is written procedure for destruction of
defective/unsafe devices
K SELF INSPECTION / Internal
Audit:
I Short Description of the The internal audit system verifies whether the
internal audit system activities related to medical devices comply with
the plan through meetings
There are documented procedures for the
internal a diet system and for the follow-up
actions
The results of the internal audit documented are
brought to the attention of the personnel having
responsibility for the area and activities
inspected
The system is ensure that those responsible for
the real or activity take timely corrective action
on the deficiencies found
L CONTRACT ACTIVITIES
I Description of the way Contract, agreement
in which the compliance
of the contract acceptor is
assessed
