PERFORMANCE RE-QUALIFICATION

OF
COMPRESSION MACHINE
NAME OF THE EQUIPMENT : Compression Machine

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 Compression Machine

Protocol No. Report No. Equipment ID No.: Page

2 of 15
XXXXXXXXX YYYYYYYYYYY ZZZZZZZ No.

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 -13
3.1 Training 7
3.0 3.2 Equipment Identification 8
3.3 Verification of Performance of the Compression Machine 9-11
3.4 Deviation And Corrective Action 12
4.0 Acceptance criteria 13
5.0 Summary and conclusion 13
6.0 Post approval signature 14
Appendix 15
7.0 7.1 Abbreviation 15
7.2 List of Document 15
 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

Performance Re-Qualification Protocol for Compression Machine

Protocol No. Report No. Equipment ID No.: Page

3 of 15
XXXXXXXXX YYYYYYYYYYY ZZZZZZZ No.

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 Compression Machine

Protocol No. Report No. Equipment ID No.: Page

4 of 15
XXXXXXXXX YYYYYYYYYYY ZZZZZZZ No.

2.0 OVERVIEW
The Performance Re-Qualification of Compression Machine 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 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 Compression Machine 27 Station is adequate to support the process for which the system
is intended.
2.2 BACKGROUND
The Compression Machine supplied by Fluidpack, Equipment I.D. XXXXX installed in Compression
area at XYZ (Company Name). This protocol defines the methods and documentation that shall be
used to evaluate the performance attributes of Compression Machine 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 Compression Machine

Protocol No. Report No. Equipment ID No.: Page

5 of 15
XXXXXXXXX YYYYYYYYYYY ZZZZZZZ No.

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 major components of the equipment are identified us:-
• Powder Feeding unit.
• Compression unit
• Hydraulic power pack assembly
• Discharge unit
The Fluidpack – 27 Station – D Tooling, a double rotary high speed tablet press, is a machine in
incorporated with the feeding arrangement, lubrication and electromagnetic clutch.
Powder feeding unit has S.S. 316 Hopper of capacity 16 Ltrs. rests on top of the machine which holds
the powder in it and delivers to the feeding assembly.
Powder transfer unit Consists S.S. 316 inlet connector, which links the hopper and the feeder.
Drive unit has main motor of 7.5HP drives a very high reduction gearbox unit using an electromagnetic
clutch and a timing belt. The gearbox unit consists of a Phosphorus bronze worm wheel and a worm
shaft. Turret is a three piece structure having the center die tablet of S.S. 316 and upper and lower piece
of cast iron of SG 400/15. The upper piece holds the upper punches, which rests on the upper cam
tracks with the cam plate. Similarly, the lower piece holds the lower punches that travel on the lower
cam tracks and Dozer.
Compression unit comprises upper main pressure roll assembly having a roll centre, pressure roll and
pressure roll pin. The roll centre holds the pressure roll and is locked by using external upper punch
penetration assembly is responsible for the entry height of the upper punch in the die. Tablet thickness
assembly is responsible in deciding the tablet thickness.
Weight dozer assembly is responsible for adjusting the weight of the tablet by varying the depth of fill.
The depth of fill is adjusted by the upward and downward movement of the weight adjusting head
through a dozer adjusting screw with the help of dial.
 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

Performance Re-Qualification Protocol for Compression Machine

Protocol No. Report No. Equipment ID No.: Page

6 of 15
XXXXXXXXX YYYYYYYYYYY ZZZZZZZ No.

Hydraulic power pack assembly system control the safety overload mechanism, which governs the
maximum pressure, level, at which particular tablets are being made. The oil reservoir for this system is
located in front LH corner within lower cabinet. It can be accessed by removing the lower side guard
(LH). The oil level in the reservoir should be checked regularly through the oil level indicator.
3.0 Performance Re-Qualification Procedure
The following procedure shall be used for Requalification of Compression Machine:
• Training shall be imparted to the concerned personal on Performance Re-Qualification protocol.
• Verification of performance of machine done by monitoring the physical parameters of the product
at the tablet compression stage.
• The performance verification of compression machine check at different speed, different thickness
pressure and different level of powder in hopper.
• 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.
• 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.
• 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___________________________
 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

Performance Re-Qualification Protocol for Compression Machine

Protocol No. Report No. Equipment ID No.: Page

7 of 15
XXXXXXXXX YYYYYYYYYYY ZZZZZZZ No.

3.2 EQUIPMENT IDENTIFICATION

Description Specification Observation Remark

Equipment Name

Model

Sr. No.

No. of Station

Capacity

RPM (Max.)

Max. Pressure

I.D. No.

Name of the Supplier

Equipment Location

Facility Oral Dosages Facility

Area Compression Area

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

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

Performance Re-Qualification Protocol for Compression Machine

Protocol No. Report No. Equipment ID No.: Page

8 of 15
XXXXXXXXX YYYYYYYYYYY ZZZZZZZ No.

3.3 VERIFICATION OF PERFORMANCE OF THE COMPRESSION MACHINE

3.3.1 PERFORMANCE VERIFICATION AT MINIMUM SPEED_______________

PRODUCT NAME_______________________________________________________

BATCH NO.______________________ BATCH SIZE (KG)_______________________

Acceptance Criteria As per Observations Checked By

Product Parameters
BMR LHS RHS Sign/Date

Average Weight

Individual weight variation

Thickness

Hardness

Friability

Disintegration Time

3.3.2 PERFORMANCE VERIFICATION AT MAXIMUM SPEED ____________

PRODUCT NAME_______________________________________________________

BATCH NO.______________________ BATCH SIZE (KG)_______________________

Acceptance Criteria As per Observations Checked By

Product Parameters
BMR LHS RHS Sign/Date
Average Weight
Individual weight variation
Thickness
Hardness
Friability
Disintegration Time
 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

Performance Re-Qualification Protocol for Compression Machine

Protocol No. Report No. Equipment ID No.: Page

9 of 15
XXXXXXXXX YYYYYYYYYYY ZZZZZZZ No.

3.3.3 PERFORMANCE VERIFICATION AT HIGH HARDNESS (MAXIMUM THICKNESS PRESSURE)

PRODUCT NAME_______________________________________________________

BATCH NO.______________________ BATCH SIZE (KG)_______________________

Acceptance Criteria As per Observations Checked By

Product Parameters
BMR LHS RHS Sign/Date

Average Weight

Individual weight variation

Thickness

Hardness

Friability

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

Performance Re-Qualification Protocol for Compression Machine

Protocol No. Report No. Equipment ID No.: Page

10 of 15
XXXXXXXXX YYYYYYYYYYY ZZZZZZZ No.

3.3.4 PERFORMANCE VERIFICATION AT LOW HARDNESS (MINIMUM THICKNESS PRESSURE)

PRODUCT NAME_______________________________________________________

BATCH NO.______________________ BATCH SIZE (KG)_______________________

Acceptance Criteria As per Observations Checked By

Product Parameters
BMR LHS RHS Sign/Date

Average Weight

Individual weight variation

Thickness

Hardness

Friability

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

Performance Re-Qualification Protocol for Compression Machine

Protocol No. Report No. Equipment ID No.: Page

11 of 15
XXXXXXXXX YYYYYYYYYYY ZZZZZZZ No.

3.3.5 PERFORMANCE VERIFICATION AT POWDER LEVEL IN HOPPER

PRODUCT NAME_______________________________________________________

BATCH NO.______________________ BATCH SIZE (KG)_______________________

Full Level Hopper

Acceptance Criteria As per Observations Checked By
Product Parameters
BMR LHS RHS Sign/Date
Average Weight
Individual weight variation
Thickness
Hardness
Friability
Disintegration Time
Half Level Hopper
Average Weight
Individual weight variation
Thickness
Hardness
Friability
Disintegration Time
Low Level Hopper
Average Weight
Individual weight variation
Thickness
Hardness
Friability
Disintegration Time
 JSA VALIDATION SERVICES
BADDI, H.P-BHARAT (INDIA)

Performance Re-Qualification Protocol for Compression Machine

Protocol No. Report No. Equipment ID No.: Page

12 of 15
XXXXXXXXX YYYYYYYYYYY ZZZZZZZ No.

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 Compression Machine

Protocol No. Report No. Equipment ID No.: Page

13 of 15
XXXXXXXXX YYYYYYYYYYY ZZZZZZZ No.

4.0 ACCEPTANCE CRITERIA

Performance Re-Qualification of Compression Machine shall be considered acceptable when
requirements listed in section 3.0 of this protocol has been fulfilled and all the components of
Compression Machine 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 Compression Machine

Protocol No. Report No. Equipment ID No.: Page

14 of 15
XXXXXXXXX YYYYYYYYYYY ZZZZZZZ No.

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 Compression Machine

Protocol No. Report No. Equipment ID No.: Page

15 of 15
XXXXXXXXX YYYYYYYYYYY ZZZZZZZ No.

7.0 APPENDIX
7.1 ABBREVIATIONS

Sr. No. : Serial number

RPM : Rotation per minutes

SOP : Standard operating procedure

Kg : Killogram

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