Operational Qualification of Polarimeter

TABLE OF CONTENT

1. Objective
2. Purpose
3. Control panel testing
4. Standard Operating Procedure verification
5. Instrumentation Calibration
6. Summary of Operational Qualification

1. OBJECTIVE

The purpose of this study is to qualify and certify the operational performance of POLARIMETER, MODEL- ADP440+ at PharmaGuide Limited.

This study verifies:

• Verifies that the Instrument consistently operates within a specified set of parameters under normal operational conditions.
• Assure that the Instrument performance is adequate to support the process for which the Instrument is intended for
• Demonstrates the completeness and adequacy of Standard Operating procedure and calibration procedure.

2. PURPOSE

The purpose of this protocol is to establish documentary evidence to ensure that the installed POLARIMETER, MODEL- ADP440+ will operate reproducibly and consistently within its full dynamic range of operation according to manufacturer’s specifications.

3. CONTROL PANEL TESTING

Objective:

To verify that all components on the control panel function as designed.

Testing procedure:

• Check all the components on the key panel are properly labeled/identified
• Turn on the power to the key panel
• Set the required controls
• Verify the function of each Key/component on the panel against its specification
• Observe and record the responses of each component of the panel

Control Panel Testing:

• To check the role of the control panel key

Control Panel Key	Use	Observation
Power Key	To switch on the instrument and switch to standby mode
Power Indicator	Standby- Red On- Green
Arrow Key	Forward-back key for negotiating through menus
Alpha-numeric keys	Keys for entering letters and numbers
Soft keys	To change the function of the display

Checked By:__________                         Verified By:__________

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• To check the operation of measurement parameters in the measurement screen

Step No	Parameters	Method of Testing	Acceptance Criteria	Observation
1	Operator	Enter the name of the operator	The operator's name shall enter
2	Sample Name	Enter the name of the sample	Sample name shall enter
3	Measurement Mode	Set optical rotation mode	Set mode shall display as an optical rotation
		Set specific optical rotation mode	Set mode shall display a specific optical rotation
		Set Concentration mode	Set mode shall display as Concentration
4	Cell length	Enter the length of the cell as X mm	Cell length shall show as X mm
5	Temperature	Select the temperature where the temperature reading required	The display shall show the temperature
6	Correction factor	Enter correction factor	Automatically correction shall take place

Checked By:__________                      Verified By:___________

4. STANDARD OPERATING INSTRUCTIONS VERIFICATION

The following Standard Operating Procedures were verified as important for Effective Performance of POLARIMETER, MODEL- ADP440+

Sr. No.	SOP TITLE	SOP No.	VERIFIED BY
1	Operation and calibration Procedure of POLARIMETER, MODEL- ADP440+

5. INSTRUMENT CALIBRATION VERIFICATION

SOP Title: OPERATION AND CALIBRATION PROCEDURE OF POLARIMETER, MODEL- ADP440+

SOP No:

Calibration Date: 

6. SUMMARY OF THE OPERATION QUALIFICATION

Description	Yes/No	Checked by
All acceptance Criterion outlined in the Operational qualification was met
All applicable data sheets were signed, checked, and verified.
Standard operating Instructions/ calibration Procedures were verified for completeness and accuracy

POST-APPROVAL

	Signatories	Signature	Date
Executed by	Quality control
Reviewed by	Quality control
Approved by	Quality Assurance

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