Operational Qualification for Analytical Balance

Table of Contents

1. Objective
2. Purpose
3. Operational Testing
4. Key Panel Testing
5. Standard Operating Procedure verification
6. Instrumentation Calibration
7. Summary of Operational Qualification

1. Objective

This study aims to qualify and certify the operational performance of ANALYTICAL BALANCE 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

This protocol aims to establish documentary evidence to ensure that the installed ANALYTICAL BALANCE will operate reproducibly and consistently within its full dynamic range of operation according to the manufacturer’s specifications.

3. Key Panel Testing

Objective:

To verify that all components on the key 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.

3.1 During measurement

Power Key

Step No	Method of Testing	Acceptance Criteria	Observation
1	Press once and released
2	Press and hold for 3 Sec

Checked By:__________                             Verified By:__________ 

Cal Key

Step No	Method of Testing	Acceptance Criteria	Observation
1	Press once and released
2	Press and hold for 3 Sec

Checked By:__________                             Verified By:__________  

O/T Key

Step No	Method of Testing	Acceptance Criteria	Observation
1	Press once and released

Checked By:__________                             Verified By:__________ 

UNIT Key

Step No	Method of Testing	Acceptance Criteria	Observation
1	Press once and released

Checked By:__________                             Verified By:__________ 

1d/10d Key

Step No	Method of Testing	Acceptance Criteria	Observation
1	Press once and released

Checked By:__________                             Verified By:__________ 

ALSO READ: Installation Qualification of FTIR (IR Affinity-1S)

3.2 During Menu Item Selection

Power Key

Step No	Method of Testing	Acceptance Criteria	Observation
1	Press once and released
2	Press and hold for 3 Sec

Checked By:__________                             Verified By:__________

Cal Key

Step No	Method of Testing	Acceptance Criteria	Observation
1	Press once and released

Checked By:__________                             Verified By:__________

O/T Key

Step No	Method of Testing	Acceptance Criteria	Observation
1	Press once and released

Checked By:__________                             Verified By:__________

UNIT Key

Step No	Method of Testing	Acceptance Criteria	Observation
1	Press once and released

1d/10d Key

Step No	Method of Testing	Acceptance Criteria	Observation
1	Press once and released

Checked By:__________                             Verified By:__________

ALSO READ: Operational Qualification of Polarimeter

4. Operational Testing

4.1 Linearity Test

Objective:

To provide a method for checking the Linearity of weighing of balance in the range of 0.01 mg to 220gm

Procedure:

• Place 100gm weight on the pan, allow the balance to stabilize, and then note the displayed weight.
• Add 50gm weight on the pan, allow the balance to stabilize, and then note the displayed weight.
• Add 20gm weight on the pan, allow the balance to stabilize, and then note the displayed weight.
• Add 10gm weight on the pan, allow the balance to stabilize, and then note the displayed weight.
• Add 5gm weight on the pan, allow the balance to stabilize, and then note the displayed weight
• Add 2gm weight on the pan, allow the balance to stabilize, and then note the displayed weight.
• Add 2gm weight on the pan, allow the balance to stabilize, and then note the displayed weight.
• Add 1gm weight on the pan, allow the balance to stabilize, and then note the displayed weight.
• Add 500mg weight on the pan, allow the balance to stabilize, and then note the displayed weight.
• Add 200mg weight on the pan, allow the balance to stabilize, and then note the displayed weight.
• Add 100mg weight on the pan, allow the balance to stabilize, and then note the displayed weight.
• Remove 100mg weight on the pan, allow the balance to stabilize, and then note the displayed weight.
• Remove 200mg weight on the pan, allow the balance to stabilize, and then note the displayed weight.
• Remove 500mg weight on the pan, allow the balance to stabilize, and then note the displayed weight.
• Remove 1g weight on the pan, allow the balance to stabilize, and then note the displayed weight.
• Remove 2g weight on the pan, allow the balance to stabilize, and then note the displayed weight.
• Remove 2g weight on the pan, allow the balance to stabilize, and then note the displayed weight.
• Remove 5g weight on the pan, allow the balance to stabilize, and then note the displayed weight.
• Remove 10g weight on the pan, allow the balance to stabilize, and then note the displayed weight.
• Remove 20g weight on the pan, allow the balance to stabilize, and then note the displayed weight.
• Remove 50g weight on the pan, allow the balance to stabilize, and then note the displayed weight.
• Remove 100g weight on the pan, allow the balance to stabilize, and then note the displayed weight.
• Record the displayed weight in the Linearity Test record as per annexure-I.

Acceptance Criteria: The difference between the two readings should be within 0.01%

4.2 Corner Load Test

Objective:

To provide a method for carrying out corner load tests for weighing balance

Procedure:

• Operation shall be done as per standard operation procedure.
• Place 50g weight on the front side right corner of the pan, allow the balance to stabilize, and note down the displayed weight.
• Place 50g weight on the front side left corner of the pan, allow the balance to stabilize, and note down the displayed weight.
• Place 50g weight on the back side right corner of the pan, allow the balance to stabilize, and note down the displayed weight.
• Place 50g weight on the back side left corner of the pan, allow the balance to stabilize, and note down the displayed weight.
• Place 50g weight on the center of the pan, allow the balance to stabilize, and note down the displayed weight.
• Record all the observations in the annexure-II.

Acceptance criteria: Weight on all the sides should be 50 ± 0.01g

5. Standard Operating Instructions Verification

• The following Standard Operating Procedures were verified as important for Effective Performance of Analytical balance.
• SOP TITLE: Operation and calibration Procedure of Analytical balance.
• Refer annexure- III for SOP.

6. Instrument Calibration Verification

• SOP Title: OPERATION AND CALIBRATION PROCEDURE OF ANALYTICAL BALANCE
• SOP No :
• Calibration Date:
• Refer to annexure-IV for the calibration data

7. Summary of the Operational Qualification

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

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

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