Document number:

DT12 Automatic Dissolution Tester

Installation qualification,Operation qualification

and Performance qualification plan/report

Jinan Haosoo Analytical Instruments Co., Ltd

2
 Plan review and approval

Manufacturer(with a seal): Jinan Haosoo Analytical Instruments Co., Ltd

Post Signature Date

Compile Engineer

Review Manager

Approval Director

User unit:

Post Signature Date

Compile Engineer

Review Manager

Approval Director

Version history:

version Change description

Declaration: This validation protocol reserves the right to modify and is subject to updates without

prior notice.
If you have any valuable suggestions or opinions on this validation plan, please contact us through

the following methods.

Manufacturer: Jinan Haosoo Analytical Instruments Co., Ltd
Address: 7000 Jingshi Road, Hi-Tech Zone, Jinan,China
Service Phone: 0531-88980078
Email: info@haosoo.com.cn

1
1. Installation Qualification

1.1 Device Information

Instrument Instrument

Name model

Instrument
Manufacturer
number

Using Place of

departments placement

1.2 Environmental requirements

Table 1 Confirmation of instrument installation environment requirements

Inspection
Require Test method Result Yes/No
content

No strong electromagnetic fields

and high-frequency instruments;

Good ventilation and no high

Environment concentration of dust; No strong visualization Yes□ No□

vibration, no corrosive gas; No

direct sunlight or direct radiation

from other heat sources.

Environmental Hygrotherm
10℃—28℃ Yes□ No□
temperature ograph

Relative ≤80% Hygrotherm

Yes□ No□
humidity ograph

A stable and horizontal

experimental table with an area

Installation recommended to be greater than

visualization Yes□ No□
position 100cm × 80cm, with a load-

bearing capacity greater than

150Kg.

2
 voltage 220±10%V/AC,50Hz visualization Yes□ No□

Acceptable standards Yes/No

All environmental conditions and public facilities meet the

Yes□ No□
requirements

Notes:

Implementer Date

Reviewer Date

1.3 File check

Table 2 File confirmation

File description File name Storage location Yes/No

Instrument DT12 Automatic Dissolution

Yes□ No□
manual Tester User Manual

DT12 Automatic Dissolution

Packing list Yes□ No□
Tester User Manual

Acceptable standards Yes/No

All reference documents are available Yes□ No□

Notes:

Implementer Date

Reviewer Date

3
1.4 Control system inspection
Table 3 Control system inspection

Project Content Test method Actual situation

Jinan Haosoo Analytical Instruments

Manufacturer visualization
Co., Ltd

name visualization app-release_dissolution

Software version visualization

information File format visualization apk

Installation position visualization /data/data/com.hanon.dissolution

/data/data/com.hanon.dissolution/
Data file save location visualization
databases

Firmware
Firmware version visualization Android4.4.2
Information

Acceptable standards Yes/No

The hardware composition and equipment parameters of the

Yes□ No□
control system meet the instrument requirements

Notes:

Implementer Date

Reviewer Date

1.5 Installation checklist

Table 4 Installation Confirmation Checklist

Project Content Test method Yes/No

Unpacking 1.The instrument packaging is intact, without any visualization Yes□ No□

4
 unpacking, damage, collision, wetting, moisture,

deformation.

2.After unpacking, the appearance of the

instrument and accessories should be free of

damage, rust, or scratches; Instruments should be

visualization Yes□ No□
labeled with information such as instrument name,

instrument model, instrument number, manufacturer,

etc.

3.Check the specifications, models, configurations,

and quantities of the host and accessories, which

situation visualization Yes□ No□
should comply with the instrument packing list and

contract requirements.

4.The inspection instrument should be

accompanied by instructions, technical guidance

materials, and a certificate of conformity. The relevant visualization Yes□ No□

information of the certificate should be consistent with

the instrument nameplate.

5.Record of other configuration parts beyond the

packing list configuration. visualization Yes□ No□

Key 1.The instrument should be placed on a horizontal

installation test bench without vibration effects, and the back of

visualization Yes□ No□
points the instrument should be at least 20cm away from the

wall.

2.The dissolution cup number corresponds to the

visualization Yes□ No□
instrument number one by one.

3.The paddle pole, basket pole, and net basket visualization Yes□ No□

numbers correspond to the instrument numbers one

by one.

5
 4.Press the constant high clutch to the bottom. visualization Yes□ No□

Acceptable standards Yes/No

The quantity of the host and accessories is consistent with the list, and there is no
Yes□ No□
damage; All required key points have been installed normally.

Notes:

Implementer Date

Reviewer Date

2. Operation Qualification

2.1 Instrument operation confirmation

Table 5 Confirmation of instrument operation

Project Instrument operation description Test method Yes/No

After the power on self-test is As described

completed, enter the user login Operation

interface, select admin as the execution

Power on Yes□ No□
username, enter the initial

password jnhs, and click [Login] to

enter the main interface。

Enter the [Automatic Control]

Automatic control interface to edit and delete Yes□ No□

methods by sliding left and right.

Manual control Enter the [Manual Control] interface Yes□ No□

to edit the experimental parameters

of the [Dissolution] interface; The

[Zone] interface allows for editing of

experimental parameters for the left

and right zones respectively.

6
 Enter the [Data Query] interface：

Can edit, view, export, and print

[experimental data].
Data query Yes□ No□
Can view, export, and print

[Scheme Data] and [Correction

Data].

Enter the [System Settings]

interface to perform basic settings

such as self check, preheating,

System settings password modification, and Yes□ No□

advanced settings such as

calibration, network settings, and

system upgrades.

Enter the [Debugging] interface to

Debug Yes□ No□
test the functions of speed,
temperature, dosing, sampling rack
lifting, and machine head lifting
Enter the [Help] interface to view

Help information about this machine and Yes□ No□

error notifications.

End the test and press the

Power offe instrument power switch to turn off Yes□ No□

the instrument.

Acceptable standards Yes/No

The instrument can be shut down normally according to

Yes□ No□
the operating manual without any abnormalities.

The instrument can operate normally, and all buttons of

Yes□ No□
the instrument can operate normally.

7
 Notes:

Implementer Date

Reviewer Date

2.2 Confirmation of user management

Table 6 Confirmation of user management

Permission type Administrators Tester Test method Yes/No

Delete data √ × Yes□ No□

Delete modify
√ × Yes□ No□
administrator user
Perform
Delete and modify
operations that
the experimenter √ × Yes□ No□
meet the
Permission user
corresponding
setting Create administrator
√ × level and are not Yes□ No□
confirmation user
allowed, or
Create an
√ × check Yes□ No□
experimenter user
permission
View traceability √ √ Yes□ No□
settings
Modify create delete
√ √ Yes□ No□
method

Sample testing √ √ Yes□ No□

Project Procedure Require Yes/No

User name and Log in as administrator and enter the

Login succeeded Yes□ No□
password settings correct password

check Login as administrator with incorrect Login failed Yes□ No□

password

8
 Log in as an experimenter and enter the
Login succeeded Yes□ No□
correct password

Login as an experimenter with incorrect

Login failed Yes□ No□
password

After entering the fingerprint, you can

successfully log in with the fingerprint Login succeeded Yes□ No□

password

No fingerprint input, login failed with

Login failed Yes□ No□
fingerprint password

Acceptable standards Yes/No

Each group's permissions meet system requirements Yes□ No□

The operating system has at least 2 levels of operation and management permissions,
Yes□ No□
and the corresponding permissions at each level meet the system security requirements.

Only those who enter the correct password or successfully enter their fingerprint are

allowed to access their user level. Those who enter the wrong password or have no Yes□ No□

fingerprint will be rejected.

Notes:

Implementer Date

Reviewer Date

2.3 Confirmation of audit trail

Table 7 Confirmation of audit trail

Project Content Test method Yes/No

Operation records visualization Yes□ No□

login/logout visualization Yes□ No□

Audit trail
Sample test visualization Yes□ No□

Method edit visualization Yes□ No□

9
 Acceptable standards Yes/No

For operation records, user login, etc., there are records that can
Yes□ No□
be queried.

Notes:

Implementer Date

Reviewer Date

2.4 Test confirmation under extreme conditions

Table 8 Confirmation of operation under extreme conditions

Project Procedure Require Yes/No

Inspection Sudden power outage, power The instrument can be used

Yes□ No□
of on again normally

extreme Parameter setting exceeds the The instrument will prompt not to
Yes□ No□
conditions range execute the action

Acceptable standards Yes/No

Testing for sudden power outage, signal interruption, abnormal parameter

Yes□ No□
settings, etc.Can be used normally.

Notes:

Implementer Date

Reviewer Date

3.Performance Qualification

3.1 Salicylic acid calibration tablets

3.1.1 Confirmation of reagents and instruments
3.1.1.1 Goal
Ensure that all reagents and instruments used for validation meet standard requirements.

10
 3.1.1.2. Procedure
Each required reagent needs to be labeled with its name, source, specification, etc.
Each instrument used meets the requirements of the pharmacopoeia.
3.1.1.3. Acceptable standards
All reagents need to be labeled with names, specifications, sources, and expiration dates.
Confirm the model, calibration date, and expiration date of all instruments.
3.1.1.4. Result

Fill out Tables 9 and 10,if the requirement is not applicable ， fill in"Yes/No" ， And indicate the

reason in the remarks column.

Record any non conformities that occurred during the implementation process in the deviation

report.

Table 9 Confirmation of reagents required for performance confirmation

Reagents name Require Source Notes

China Food and Drug Control

Salicylic acid 300mg/tablet
Research Institute

Sodium
Analytical pure
hydroxide

Kdp Analytical pure

Salicylic acid
China Food and Drug Control
reference 100mg
Research Institute
substance

Purified water III or I

Acceptable standards Yes/No

The reagents used are within their validity period Yes□ No□

Notes:

11
 Implementer Date

Reviewer Date

Table10 Confirmation of instruments required for performance confirmation

Instrument Model Date period of validity Notes

Electronic

balance

Ultraviolet

spectrophotom

eter

Acceptable standards Yes/No

The instrument used is within its validity period Yes□ No□

Notes:

Implementer Date

Reviewer Date

3.1.2 Dissolution test results of salicylic acid tablets

3.1.2.1 Goal
Confirm that the results of the basket or paddle method for the applicability of this instrument

comply with the instructions for salicylic acid tablets and the regulations of the CHP.
3.1.2.2 Procedure
Perform the dissolution test of salicylic acid tablets according to the operating procedures in the

"Instructions for Salicylic Acid Tablets".

3.1.2.3 Acceptable standards
The dissolution of 6 salicylic acid standard tablets and the relative standard deviation of dissolution

of 6 salicylic acid standard tablets are consistent with the provisions in the user manual and can

meet the requirements of the CHP.

3.1.2.4 Result

12
 Fill in form 11,12, if not applicable, fill in "N / A" and indicate the reason in the remarks column.

Non-conformance occurring during implementation are recorded in the deviation report.

Table 11 Result of salicylic acid reference substance

Sample name Reference substance 1 Reference substance 2

Reference Abs

Response factor

Average response

factor

Response factor

ratioF1/F2

Acceptable standards Yes/No

The results comply with the user manual for salicylic acid tablets Yes□ No□

Notes:

Implementer Date

Reviewer Date

Table 12 Dissolution test results of salicylic acid tablets □Basket Apparatus □Paddle

Apparatus

Sample
1 2 3 4 5 6 7 8 9 10 11 12
name

Weight（mg

Absorbance
（Abs）

13
Dissolution（
%）
Average
value（%）
RSD（%）

Acceptable standards Yes/No

The results comply with the user manual for salicylic acid tablets Yes□ No□

Notes:

Implementer Date

Reviewer Date

Table 13 Dissolution test results of salicylic acid tablets □Basket Apparatus □Paddle

Apparatus

Sample
1 2 3 4 5 6 7 8 9 10 11 12
name

Weight（mg

Absorbance
（Abs）
Dissolution
（%）
Average
value（%）
RSD（%）

Acceptable standards Yes/No

The results comply with the user manual for salicylic acid tablets Yes□ No□

Notes:

Implementer Date

14
 Reviewer Date

3.2 Mechanical parameter confirmation

3.2.1 Goal
Confirm the mechanical parameters to ensure that the dissolution tester meets the technical

requirements specified in the Chinese Pharmacopoeia and the Guiding Principles for Mechanical

Validation of Drug Dissolution Testers, and ensure the accuracy and reproducibility of in vitro

dissolution test data.

3.2.2 Procedure
Confirm the mechanical parameters according to the requirements of the "Guiding Principles for

Mechanical Validation of Drug Dissolution Meters"。

3.2.3 Acceptable standards
Comply with the technical requirements of the "Guiding Principles for Mechanical Validation of

Drug Dissolution Meters".

3.2.4 Result
Fill in form 13,14, if not applicable, fill in "N / A" and indicate the reason in the remarks column.

Table 14 Dissolution meter mechanical verification record form——Basket Apparatus

Technical
Parameters Tools Measurement points Result
requirement

Place the level meter 1.

on the horizontal 2.
Dissolution
panel of the
meter Level gauge ≤0.5°
dissolution meter
levelness
and measure in two
vertical directions

15
 1 up1: down2:
2 up1: down2:
3 up1: down2:
4 up1: down2:
Close to the basket 5 up1: down2:
Basket axis axis and measure in 6 up1: down2:
Level gauge 90.0°±0.5°
verticality two directions with 7 up1: down2:
an angle of 90 ° 8 up1: down2:
9 up1: down2:
10 up1: down2:
11 up1: down2:
12 up1: down2:
1 up1: down2:
2 up1: down2:
3 up1: down2:
4 up1: down2:
Perpendicu Close to the cup wall 5 up1: down2:
larity of and measure in two 6 up1: down2:
Level gauge 90.0°±1.0°
dissolution directions with an 7 up1: down2:
cup angle of 90 ° 8 up1: down2:
9 up1: down2:
10 up1: down2:
11 up1: down2:
12 up1: down2:
1 up1: down2:
2 up1: down2:
3 up1: down2:
Coaxiality 4 up1: down2:
between 5 up1: down2:
Upper measurement
dissolution 6 up1: down2:
Dialgage point and lower ≤2.0mm
cup and 7 up1: down2:
measurement point
basket 8 up1: down2:
shaft 9 up1: down2:
10 up1: down2:
11 up1: down2:
12 up1: down2:
1. 2.
3. 4.
20mm on the
Basket axis 5. 6.
Dialgage upper edge of the ≤1.0mm
swing 7. 8.
basket
9. 10.
11. 12.

16
 1. 2.
3. 4.
Basket Bottom edge of 5. 6.
Dialgage ≤1.0mm
swing basket 7. 8.
9. 10.
11. 12.
1. 2.
3. 4.
Basket Basket lower 5. 6.
Set high ball 25±2mm
depth edge 7. 8.
9. 10.
11. 12.
50rpm
1. 2.
3. 4.
5. 6.
7. 8.
9. 10.
Tachometer
Basket 11. 12.
±4%
shaft speed 100rpm
1. 2.
3. 4.
5. 6.
7. 8.
9. 10.
11. 12.
1. 2.
Temperatur 3. 4.
e inside the Tachometer Dissolve out of 5. 6.
37℃±0.5℃ 7. 8.
dissolution the cup
cup 9. 10.
11. 12.

Acceptable standards Yes/No

Comply with the technical requirements of the "Guiding Principles for Mechanical
Yes□ No□
Validation of Drug Dissolution Meters".

Implementer Date

Reviewer Date

17
 Table15 Dissolution meter mechanical verification record form——Paddle Apparatus

Technical
Parameters Tools Measurement points Result
requirement

Place the level meter on the 1.

Dissolution horizontal panel of the 2.
Level
meter dissolution meter and ≤0.5°
gauge
levelness measure in two vertical
directions
1 up1: down2:
2 up1: down2:
3 up1: down2:
4 up1: down2:
5 up1: down2:
Close to the basket axis and
Paddle axis Level 6 up1: down2:
measure in two directions 90.0°±0.5°
verticality gauge 7 up1: down2:
with an angle of 90 °
8 up1: down2:
9 up1: down2:
10 up1: down2:
11 up1: down2:
12 up1: down2:
1 up1: down2:
2 up1: down2:
3 up1: down2:
4 up1: down2:
5 up1: down2:
Perpendicula
Close to the cup wall and 6 up1: down2:
rity of Level
measure in two directions 90.0°±1.0° 7 up1: down2:
dissolution gauge
with an angle of 90 ° 8 up1: down2:
cup
9 up1: down2:
10 up1: down2:
11 up1: down2:
12 up1: down2:

18
 1 up1: down2:
2 up1: down2:
3 up1: down2:
4 up1: down2:
Coaxiality
5 up1: down2:
between Upper measurement point
6 up1: down2:
dissolution Dialgage and lower measurement ≤2.0mm
7 up1: down2:
cup and point
8 up1: down2:
paddle shaft
9 up1: down2:
10 up1: down2:
11 up1: down2:
12 up1: down2:
1. 2.
3. 4.
Paddle axis 5. 6.
Dialgage Bottom edge of basket ≤1.0mm
swing 7. 8.
9. 10.
11. 12.
1. 2.
3. 4.
Paddle Set high 5. 6.
Basket lower edge 25±2mm
depth ball 7. 8.
9. 10.
11. 12.
50rpm
1. 2.
3. 4.
5. 6.
7. 8.
Tachom 9. 10.
Paddle eter 11. 12.
±4%
shaft speed 100rpm
1. 2.
3. 4.
5. 6.
7. 8.
9. 10.
11. 12.

19
 1. 2.
Temperature 3. 4.
Tachom 5. 6.
inside the
eter Dissolve out of the cup 37℃±0.5℃ 7. 8.
dissolution
cup 9. 10.
11. 12.

Acceptable standards Yes/No

Comply with the technical requirements of the "Guiding Principles for Mechanical Yes□ No□
Validation of Drug Dissolution Meters".

Implementer Date

Reviewer Date

4.Deviation report
All deviations that do not meet the requirements must be formally recorded by filling out a deviation

report in Form 15.Record all deviations that occurred during execution in Table 16.
5.Accessories List
Record all attachments attached to this document in Table 17.
6.Review and approval of execution
Relevant personnel review and approve the implementation results, as shown in Table 18.
Table 16 Deviation report

Deviation
Test report
number

Deviation description and suggested corrective measures

20
 Verifier Date

Review and approval of corrective measures

validation
Date
manager

Result tracking

validation
Date
manager

Yes/No
Has the deviation been resolved？
Yes□ No□

Table 17 Deviation List

Deviation number Describe Notes

21
 Table 18 Accessories List

Attachment Number of
Describe Notes
number pages

22
 Table 19 Review and approval of execution
Review the test results and raw data, and draw the final conclusion of the DT12 automatic

dissolution tester:
¨ The implementation process and results meet the requirements. There are no unresolved

deviations.
 The implementation and results cannot fully meet the requirements. There are unresolved

deviations that do not affect the final result of the validation.

 Implemented and results did not meet the requirements. There are unresolved deviations that

affect the final result of the validation. Further measures must be taken. Record the correction

results separately.

Comment:
All inspection items of this dissolution instrument meet the standards,and installation confirmation,

23
operation confirmation, and performance confirmation all meet the requirements, meeting the

guidelines for mechanical validation of drug dissolution in China, as well as regulatory requirements

such as FDA DPA-LOP.002 and ASTME2503-07 in the United States.

Reviewer:

Date:

24