Name of the Customer: - PHARMAX ENGINEERS

Location : - VIKROLI , ANDHERI

PO NO : - VERBALLY

PO Date : - 15 / 02 / 2022

Model Name : - PPM / ZHSFP – 0808 (GMP MODEL)

PERFORMANCE QUALIFICATION FOR

ZERO HOLDUP SPARKLER FILTER PRESS (ZHSFP)
Signature below indicates that the appropriate individuals have reviewed and executed document and found the
results of the execution acceptable.

Pre-Approvals
Department Name & Designation Date Signature

Post –Approvals

Department Name & Designation Date Signature

Prepared By. Submitted By. Signed By. Company Stamp.

PAL PHARMA MACHINERY PAL PHARMA MACHINERY

 Name of the Customer: - PHARMAX ENGINEERS

Location : - VIKROLI , ANDHERI

PO NO : - VERBALLY

PO Date : - 15 / 02 / 2022

Model Name : - PPM / ZHSFP – 0808 (GMP MODEL)

S.NO CONTENT PG.NO

1 ROLES & RESPONSIBILITIES : ---------------------------------------------------------- 3.

2 OBJECTIVES : ---------------------------------------------------------- 3.
3 SCOPE OF PROTOCOL : ---------------------------------------------------------- 3.
4 EXCECUTION PROCEDURE : ---------------------------------------------------------- 4.

5 CRITERIA FOR ACCEPTABILITY : ---------------------------------------------------------- 5.

6 INTERPRETATION OF RESULTS : ---------------------------------------------------------- 5.

7 PREREQUISITE : ---------------------------------------------------------- 6.

8 TEST : ---------------------------------------------------------- 7.

8.1 POWER SUPPLY REPORT : ---------------------------------------------------------- 7.

8.2 UTLITY VERIFICATION REPORT : ---------------------------------------------------------- 8.

8.3 LEAKAGE VERIFICATION REPORT : ---------------------------------------------------------- 9.

9 CONCLUSION : ---------------------------------------------------------- 10.

10 DEVIATION REPORTS PROCEDURE : ---------------------------------------------------------- 11

11 APPENDIX A - DQ DEVIATION REGISTER : ---------------------------------------------------------- 12.

12 APPENDIX B - DEVIATION REPORT SHEET : ---------------------------------------------------------- 13.

PRE – APPROVALS EVALUATION / CORRECT

12.1 : ---------------------------------------------------------- 14.
ACTION

13 APPENDIX C - ATTACHMENTS REGISTER : ---------------------------------------------------------- 15.

14 SIGNATURE RECORD : ---------------------------------------------------------- 16.

.

Prepared By. Submitted By. Signed By. Company Stamp.

PAL PHARMA MACHINERY PAL PHARMA MACHINERY

 Name of the Customer: - PHARMAX ENGINEERS

Location : - VIKROLI , ANDHERI

PO NO : - VERBALLY

PO Date : - 15 / 02 / 2022

Model Name : - PPM / ZHSFP – 0808 (GMP MODEL)

1) ROLES & RESPONSIBILITIES

Sr.
Department Responsibility
No.
To prepare the qualification report and co – ordinate the entire
1. Maintenance Executive
Qualification activity.

To witness the qualification study and ascertain the study is conducted as

2. Quality Assurance Executive
per the protocol

3. Production Executive To executive qualification study in co – ordination with others

2) OBJECTIVE

The purpose of this Performance Qualification (OQ) is to confirm that an item of equipment, or other

system, as currently installed, operate in accordance to manufactures specifications and in accordance

with Current Good Manufacturing Practices (cGMP’s).

 To demonstrate that the functions are working properly without errors and missing functionalities.

 To ensure that the system connect to all its units, be networked or be directly connected and use the

connectivity for the various functions involved.

 To ensure that the equipment is in a satisfactory state to allow the OQ to be performed safely and with

consistently repeatable results.

 To ensure that all instruments are categorized with respect to Calibration prior to OQ.

3) SCOPE OF PROTOCOL

This protocol pertains to the verification of the operation of the equipment

installed at “_____________ ”

This protocol is specific to the “ZHSFP” and related Instrumentation, and does not address facility, or facility related

equipment and systems.

Prepared By. Submitted By. Signed By. Company Stamp.

PAL PHARMA MACHINERY PAL PHARMA MACHINERY

 Name of the Customer: - PHARMAX ENGINEERS

Location : - VIKROLI , ANDHERI

PO NO : - VERBALLY

PO Date : - 15 / 02 / 2022

Model Name : - PPM / ZHSFP – 0808 (GMP MODEL)

4) EXCECUTION PROCEDURE

 The Performance Qualification will comprise the approved copy of this protocol and of appended documents.

All documentation will be completed, annotated as indicated in this protocol and listed in the appropriate action.

 All people who enter data in this report will be identified in the appropriate section.

 All approval signatures are to be made in red ink.

 All data is to be entered in clear handwriting and, where possible, in blue unless otherwise instructed.

 Any correction to handwritten data will be made by deleting with a single line and initiating and dating the

correction. Also a brief reason for the correction will be given / stated.

 The protocol completer should enter his initials in the appropriate boxes to indicate the findings. ‘Ticks’ and

‘Crosses’ must not be used.

 The protocol completer should, if necessary, enter comments arising from the findings in the appropriate

comment section for the Report Approver’s attention. These comments should be continued in an appendix if

necessary. Individual comments should be initialed and dated. The reviewers and approvers of the completed

report may add initialed and dated responses to the comments if necessary.

 When each page and / or section is completed, it should be signed and dated by the personnel who carried

out the checks.

 All tests must be carried in sequence shown in this document.

 The following color conventions will be used when annotating or verifying drawing, sketches and data.

 Verified as correct : Yellow Highlighter

 Non-Verified : Green Highlighter

(Reason for non-verification in green ink adjacent to highlighted area)

 Verified as Incorrect : Blue Highlighter

 Amendments & corrections : Red Highlighter

Prepared By. Submitted By. Signed By. Company Stamp.

PAL PHARMA MACHINERY PAL PHARMA MACHINERY

 Name of the Customer: - PHARMAX ENGINEERS

Location : - VIKROLI , ANDHERI

PO NO : - VERBALLY

PO Date : - 15 / 02 / 2022

Model Name : - PPM / ZHSFP – 0808 (GMP MODEL)

5) EXECUTION PROCEDURE

The Performance Qualification of the VTD is to be considered acceptable, if it is found to comply with the

mechanical, electrical and safety requirements that it is designed to comply with. It must also meet the

requirements specified in this protocol.

6) INTERPRETATION OF RESULTS

 If the results of Performance Qualification activities do not meet the acceptance criteria, the Pharmax

Engineers Review team will meet to agree a corrective action.

 If the results of all qualification activities are acceptable, then the Performance Qualification is complete.

Prepared By. Submitted By. Signed By. Company Stamp.

PAL PHARMA MACHINERY PAL PHARMA MACHINERY

 Name of the Customer: - PHARMAX ENGINEERS

Location : - VIKROLI , ANDHERI

PO NO : - VERBALLY

PO Date : - 15 / 02 / 2022

Model Name : - PPM / ZHSFP – 0808 (GMP MODEL)

7) PREREQUISITE

 Installation Qualification must be complete before commencing Performance Qualification

 Ensure that all the tooling is removed from the equipment

 All external equipment is to be disconnected. Ensure any external STOP circuit is overridden.

 Mains power supply to the machine must be switched OFF

 All drives are free from external hindrance

Sr. Sign to
Documents Drawing No. Date Rev No.
No. confirm

1. General Assembly

2. Cartridge Assembly

3. Plates

4. Nut & Bolts

5.

Comment –

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

Verified By (Sign & Date): - ______________________.

Prepared By. Submitted By. Signed By. Company Stamp.

PAL PHARMA MACHINERY PAL PHARMA MACHINERY

 Name of the Customer: - PHARMAX ENGINEERS

Location : - VIKROLI , ANDHERI

PO NO : - VERBALLY

PO Date : - 15 / 02 / 2022

Model Name : - PPM / ZHSFP – 0808 (GMP MODEL)

8) TEST

Before the equipment is operated, the following visual checks must have been completed.

8.1) Power Supply Report

 Objective

 To ensure Correct Operation of Power supply.

 Procedure

 Couple the main power supply to the supply cable of the machine.

 Acceptance Criteria

 No power supply to the machine when M.C.B is OFF and vise – versa.

MCB ON/ OFF Supply to machine Result Pass/ Fail

MCB ON Yes

MCB Off No

Comment –

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

Verified By (Sign & Date): - ______________________.

Prepared By. Submitted By. Signed By. Company Stamp.

PAL PHARMA MACHINERY PAL PHARMA MACHINERY

 Name of the Customer: - PHARMAX ENGINEERS

Location : - VIKROLI , ANDHERI

PO NO : - VERBALLY

PO Date : - 15 / 02 / 2022

Model Name : - PPM / ZHSFP – 0808 (GMP MODEL)

8.2) Utility Verification Report

 Objective

 To ensure that when there is any failure in utility supply, machine should restart from the last failed operation.

 Procedure

 Turn off the electrical supply for 30 Sec. Turn on the supply

 Turn off the Air supply for 30 Sec. Turn on the Air supply

 Acceptance Criteria

 The machine should restart from the last failed operation.

Supply ON / Off Time Machine Restart Yes / No Result Pass/ Fail

Electric Supply 30 Sec

Comment –

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

Verified By (Sign & Date): - ______________________.

Prepared By. Submitted By. Signed By. Company Stamp.

PAL PHARMA MACHINERY PAL PHARMA MACHINERY

 Name of the Customer: - PHARMAX ENGINEERS

Location : - VIKROLI , ANDHERI

PO NO : - VERBALLY

PO Date : - 15 / 02 / 2022

Model Name : - PPM / ZHSFP – 0808 (GMP MODEL)

8.3) Leakage Verification Report

 Objective

 To ensure no leakage from sealing area

 Procedure

 After trial of the product, open the impeller and shaft.

 Check if any product has entered the bearing housing.

 Acceptance Criteria

 No leakages in the Body or the other parts.

Comment –

___________________________________________________________________________________________________

___________________________________________________________________________________________________

___________________________________________________________________________________________________

___________________________________________________________________________________________________

___________________________________________________________________________________________________

___________________________________________________________________________________________________

___________________________________________________________________________________________________

___________________________________________________________________________________________________

___________________________________________________________________________________________________

___________________________________________________________________________________________________

Verified By (Sign & Date): - ______________________.

Prepared By. Submitted By. Signed By. Company Stamp.

PAL PHARMA MACHINERY PAL PHARMA MACHINERY

 Name of the Customer: - PHARMAX ENGINEERS

Location : - VIKROLI , ANDHERI

PO NO : - VERBALLY

PO Date : - 15 / 02 / 2022

Model Name : - PPM / ZHSFP – 0808 (GMP MODEL)

9) CONCLUSION

The data required for the Performance Qualification of the equipment has been collected and entered in the

relevant sections of this protocol. Satisfactory results have been obtained except for the items identified by further

actions. These are listed in deviation report in next page.

Comment –

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

Prepared By (Sign & Date): - ______________________.

Verified By (Sign & Date): - ______________________.

Prepared By. Submitted By. Signed By. Company Stamp.

PAL PHARMA MACHINERY PAL PHARMA MACHINERY

 Name of the Customer: - PHARMAX ENGINEERS

Location : - VIKROLI , ANDHERI

PO NO : - VERBALLY

PO Date : - 15 / 02 / 2022

Model Name : - PPM / ZHSFP – 0808 (GMP MODEL)

10) DEVIATION REPORTS PROCEDURE

During OQ, a Deviation Report must be raised when there is a failure to meet acceptance criteria. The aim is to:
 Clearly describe the deviation.

 To document and approve the evaluation of the impact of the deviation.

 To document and approve the corrective action required to resolve it.

 To document the closing out of the deviation with the appropriate approvals.

Procedure

 If a test step fails to meet test acceptance criteria/method then a Deviation Report must be raised. See
Appendix.
 All Deviation Reports must be logged by completing the Deviation Report Register. See Appendix
 Each Deviation Report must reference the following identification numbers:
 Validation Protocol document reference number.
 The applicable test reference number (XX) as defined in the protocol.
 A unique deviation reference number, which comprises the specific test number and a sequential deviation
number (YY) for that test in the format XX/YY. Subsequent deviations on the same
 The person raising the deviation must clearly describe the exact nature of the deviation (why acceptance
criteria/method has not been met) using the ‘details of deviation noted’ box provided.
 The deviation must be fully evaluated and the necessary corrective action formulated and must be pre-
approved. The findings of this evaluation together with details of corrective action required to resolve the
deviation should be clearly documented by completing the ‘evaluation of deviation/corrective actions to be
taken’ box.
 Once the proposed corrective action has been pre-approved, the tester will execute the corrective work and
verify implementation of corrective action by completing the ‘Results of Corrective Action’ box. The tester will
then sign and date the Deviation report.
 The completed Deviation Report will require approval by the appropriate personnel on the Deviation Report.
 Completed Deviation Reports must be attached to the Appendix of this OQ protocol.
 This OQ document cannot be closed off until all deviations have been satisfactorily resolved.

Prepared By. Submitted By. Signed By. Company Stamp.

PAL PHARMA MACHINERY PAL PHARMA MACHINERY

 Name of the Customer: - PHARMAX ENGINEERS

Location : - VIKROLI , ANDHERI

PO NO : - VERBALLY

PO Date : - 15 / 02 / 2022

Model Name : - PPM / ZHSFP – 0808 (GMP MODEL)

11) APPENDIX A - OQ DEVIATION REGISTER

Deviation Report No. Brief Description Date Raised Date Closed Checked By

Prepared By. Submitted By. Signed By. Company Stamp.

PAL PHARMA MACHINERY PAL PHARMA MACHINERY

 Name of the Customer: - PHARMAX ENGINEERS

Location : - VIKROLI , ANDHERI

PO NO : - VERBALLY

PO Date : - 15 / 02 / 2022

Model Name : - PPM / ZHSFP – 0808 (GMP MODEL)

12) APPENDIX B - DEVIATION REPORT SHEET

Deviation No. Test Reference:

Details Of Deviation Noted:

Completed By: Date:

Evaluation Of Deviation / Corrective Actions To Be Taken:

Completed By: Date:

Prepared By. Submitted By. Signed By. Company Stamp.

PAL PHARMA MACHINERY PAL PHARMA MACHINERY

 Name of the Customer: - PHARMAX ENGINEERS

Location : - VIKROLI , ANDHERI

PO NO : - VERBALLY

PO Date : - 15 / 02 / 2022

Model Name : - PPM / ZHSFP – 0808 (GMP MODEL)

12.1) PRE – APPROVALS – EVALUATION / CORRECTIVE ACTIONS

PRE-APPROVALS - EVALUATION / CORRECTIVE ACTIONS

The following signatures pre-approve the content of the evaluation and the necessary corrective actions to be taken.

Function Pre- Approval Required (Yes / No) Name (Print) Signature Date

Results Of Corrective Action:

Completed By: Date :

APPROVALS - RESULTS OF CORRECTIVE ACTIONS/ DEVIATION CLOSE OUT

The following signatures approve the results corrective actions taken and the closure of the deviation.

Prepared By. Submitted By. Signed By. Company Stamp.

PAL PHARMA MACHINERY PAL PHARMA MACHINERY

 Name of the Customer: - PHARMAX ENGINEERS

Location : - VIKROLI , ANDHERI

PO NO : - VERBALLY

PO Date : - 15 / 02 / 2022

Model Name : - PPM / ZHSFP – 0808 (GMP MODEL)

13) APPENDIX C – ATTACHMENTS REGISTER

Description Number / Revision

Prepared By. Submitted By. Signed By. Company Stamp.

PAL PHARMA MACHINERY PAL PHARMA MACHINERY

 Name of the Customer: - PHARMAX ENGINEERS

Location : - VIKROLI , ANDHERI

PO NO : - VERBALLY

PO Date : - 15 / 02 / 2022

Model Name : - PPM / ZHSFP – 0808 (GMP MODEL)

14) SIGNATURE RECORD

Department Name & Designation Date Signature

Prepared By. Submitted By. Signed By. Company Stamp.

PAL PHARMA MACHINERY PAL PHARMA MACHINERY