PERFORMANCE RE-QUALIFICATION

OF
OCTAGONAL BLENDER
NAME OF THE EQUIPMENT : Octagonal Blender

EQUIPMENT NO. :

RQ PROTOCOL NO. :

RQ REPORT NO. :

MAKE :

CAPACITY :

LOCATION :

JSA VALIDATION SERVICES

BADDI, H.P-BHARAT (INDIA)
 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

Performance Re-Qualification Protocol for Octagonal Blender

Protocol No. Report No. Equipment ID No. Page 2 of 13
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TABLE OF CONTENTS
S. No. TITLE PAGE No.
1.0 Pre Approval 3
Overview 4-5
2.1 Purpose 4
2.0 2.2 Background 4
2.3 Responsibility 4
2.4 Equipment Description 5
Performance Re-Qualification Procedure 6 -10
3.1 Training 6
3.0 3.2 Equipment Identification 6
3.3 Verification of Performance of the Octagonal Blender 7
3.4 Deviation and Corrective Action 10
4.0 Acceptance criteria 12
5.0 Summary and conclusion 12
6.0 Post approval signature 12
Appendix 13
7.0 7.1 Abbreviation 13
7.2 List of Document 13
 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

Performance Re-Qualification Protocol for Octagonal Blender

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1.0 PRE-APPROVAL

Activity Name Designation Department Signature

Prepared by

Reviewed by

Approved by

Authorized by
 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

Performance Re-Qualification Protocol for Octagonal Blender

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2.0 OVERVIEW
The Performance Re-Qualification of Octagonal Blender is carrying out in order to provide the high
degree of assurance that the equipment performed as intended and remain in the state of control.
2.1 PURPOSE
The purpose is to provide an outline for the Performance Re-Qualification of equipment for
performance attributes to verify that:
• The system meets the user requirement Specification.
• Document the verification that equipment performs consistently and in the state of control.
• Assure that Octagonal Blender is adequate to support the process for which the system is intended.
2.2 BACKGROUND
The Octagonal Blender supplied by Falcon Machineries; Equipment I.D. XXXX installed in Blending
area at XYZ (Company Name). This protocol defines the methods and documentation that shall be
used to evaluate the performance attributes of Octagonal Blender in accordance with the user
requirement specifications and intended use. The Reason for this requalification is Periodic/Schedule
Performance Requalification.
2.3 RESPONSIBILITIES:
2.3.1 Quality Assurance:
• To prepare/Review and Approval of the Performance Re-Qualification protocol and report.
• To Impart the Training to the team before the execution of protocol
• To execute the Performance Re-Qualification protocol along with other department
• To monitor protocol completeness and technical accuracy.
2.3.2 User Department
• To Review of the Performance Re-Qualification Protocol/Report.
• To monitor the validation activities and ensuring performance attributes as per the protocol.
• To monitor protocol completeness and technical accuracy.
• To review the data and approved the qualification procedure, if found satisfactory.
• To provide personnel to assist in the execution of the protocol/report.
 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

Performance Re-Qualification Protocol for Octagonal Blender

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2.3.3 Engineering Department

• To Review the Performance Re-Qualification Protocol/Report.
• To monitor the validation activities and ensuring the performance attributes as per the protocol.
• To monitor protocol completeness and technical accuracy.
• To review the data and approved the qualification procedure, if found satisfactory.
• To provide personnel to assist in the execution of the protocol/report.
2.3.4 Equipment Description
The purpose of octagonal blender (600 Liter) is to mix various substances in dry powder and / or
granular form. Mixing can be achieved by selecting suitable RPM and suitable time period depending
on the product characteristic. It uses the principle of tumbling of powder/granules in partial void to
cause mixing. Motion is achieved by means of a motor couple to a gear box and final speed reduction
through flexible coupling. The entire drive assembly and the bearing housing are enclosed with S.S.
cover.
The drive structure is made from SS 304 Tubular section of cantilever support where in the drive
assembly and bearing are housed.
3.0 Performance Re-Qualification Procedure
The following procedure shall be used for Requalification of Octagonal Blender:
• Training shall be imparted to the concerned personal on Performance Re-Qualification protocol.
• Verification of performance of machine done by Blending of material.
• Operate the machine as per respective standard operating procedure and set the required parameter in
control panel as per product BMR.
• Record the observation in the protocol.
• Sample for Blend uniformity shall be done from the 10 different locations mentioned in protocol
• One composite sample shall be taken from Blender
• Record the Results of Analysis in respective section given in the protocol.
• The Performance of Octagonal blender shall be evaluated for minimum and maximum load.
• Suitable conclusion shall be drawn after completion of Performance Re-Qualification.
• Any deviation observed during qualification shall be recorded in the observed deviation, corrective
action and justification report section.
• Observed deviation shall be reported to the department head and quality head.
 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

Performance Re-Qualification Protocol for Octagonal Blender

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• If the observed deviation does not have any major impact on the qualification the final conclusion
shall be provided.
• If the observed deviation has major impact on the qualification, deviation shall be reported to the
manufacturer for the corrective action and qualification activity shall be done.
3.1 Training
The validation team member shall be trained on the protocol execution of validation activity and report
compilation.

Sr. No. Name of Trainee Employee Code Department Sign/Date

Name of Trainer _______________________

Trainer Sign/Date______________________
Department___________________________

3.2 EQUIPMENT IDENTIFICATION

Description Specification Observation Remark

Equipment Name Octagonal Blender

Capacity

Blender RPM

I.D. No.

Sr, No.

Model

Name of the Supplier

 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

Performance Re-Qualification Protocol for Octagonal Blender

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Equipment Location

Facility

Area

Checked By: Sign/Date Verified By: Sign/Date

3.3 PERFORMANCE VERIFICATION OF THE OCTAGONAL BLENDER

PRODUCT NAME__________________________________________________

BATCH NO._____________________________________ BATCH SIZE (KG)_______________

Set Blender RPM Observed Blending RPM Remark

Set Blending Time Observed Blending Time

Comments:…………………………………………………...….……………………..………………
………………………………………………………………………………………………………

Checked By: Sign/Date Verified By: Sign/Date

 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

Performance Re-Qualification Protocol for Octagonal Blender

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3.3.1 SAMPLING LOCATION OF BLENDED MATERIAL FOR BLEND UNIFORMITY

Sr. No. Location ID Location Name Sampling Quantity Criteria

1 T1 Top Left Side 3X (Triplicate)
2 T2 Top Middle Side 3X (Triplicate)
3 T3 Top Right Side 3X (Triplicate)
4 M1 Middle Left Side 3X (Triplicate)
5 M2 Middle Center Side 3X (Triplicate)
6 M3 Middle Right Side 3X (Triplicate)
7 B1 Bottom Left Side 3X (Triplicate)
8 B2 Bottom Middle Side 3X (Triplicate)
9 B3 Bottom Right Side 3X (Triplicate)
10 D1 Discharge Port 3X (Triplicate)
X: Average weight of Tablets
 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

Performance Re-Qualification Protocol for Octagonal Blender

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3.3.2 ANALYSIS RESULTS OF BLEND UNIFORMITY

PRODUCT NAME_____________________________________ BATCH NO._____________________ BATCH SIZE______________
ACCEPTANCE CRITERIA_______________________________ BLENDING TIME_________________ DATE____________________
MINIMUM ASSAY (%) MAXIMUM ASSAY (%) AVERAGE ASSAY (%)
LOCATION ID LOCATION NAME
BLENDING TIME POINTS BLENDING TIME POINTS BLENDING TIME POINTS
T1 Top Left Side

T2 Top Middle Side

T3 Top Right Side

M1 Middle Left Side

M2 Middle Center Side

M3 Middle Right Side

B1 Bottom Left Side

B2 Bottom Middle Side

B3 Bottom Right Side

D1 Discharge Port

Composite Composite
 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

Performance Re-Qualification Protocol for Octagonal Blender

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3.4 DEVIATION AND CORRECTIVE ACTION

Description of deviation and date observed

Person responsible for corrective action and date assigned

Corrective action taken and date conducted

Checked by: __________________ Date: ____________________

Verified by: ___________________ Date: ____________________

 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

Performance Re-Qualification Protocol for Octagonal Blender

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4.0 ACCEPTANCE CRITERIA

Performance Re-Qualification of Octagonal Blender shall be considered acceptable when
requirements listed in section 3.0 of this protocol has been fulfilled and all the components of
Octagonal Blender are performed as per the user requirement specifications.

5.0 SUMMARY AND CONCLUSION

 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

Performance Re-Qualification Protocol for Octagonal Blender

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6.0 POST APPROVAL SIGNATURE

Activity Name Designation Department Signature

Executed by

Reviewed by

Approved by

Authorized by
 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

Performance Re-Qualification Protocol for Octagonal Blender

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7.0 APPENDIX
7.1 ABBREVIATIONS

Sr. No. : Serial number

RPM : Rotation per minutes

SOP : Standard operating procedure

Kg : Kilogram

NMT : Not more than

S.S. : Stainless Steal

cGMP : Current Good manufacturing Practice

I.D. No. : Identification number

7.2 LIST OF DOCUMENTS

Annexure No. Name of Annexure

END OF DOCUMENT