Name of the Customer: - PHARMAX ENGINEERS

Location : - VIKROLI , ANDHERI

PO NO : - VERBALLY

PO Date : - 15 / 02 / 2023

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

INSTALLATION 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. This equipment is now ready for testing under the approved Installation
qualification.

Pre-Approvals

Department Name & Designation Date Signature

Sales & Marketing

Production

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 / 2023

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

S.NO CONTENT PG.NO

1 ROLES & RESPONSIBILITIES : ---------------------------------------------------------- 4.

2 OBJECTIVES : ---------------------------------------------------------- 4.

3 SCOPE OF PROTOCOL : ---------------------------------------------------------- 4.

4 EQUIPMENT LOCATION : ---------------------------------------------------------- 5.

5 EXCECUTION PROCEDURE : ---------------------------------------------------------- 6.

6 CRITERIA FOR ACCEPTABILITY : ---------------------------------------------------------- 7.

7 INTERPRETATION OF RESULTS : ---------------------------------------------------------- 7.

8 DOCUMENT CHECK : ---------------------------------------------------------- 7.

9 DRAWING CHECK : ---------------------------------------------------------- 8.

10 INSTALLATION VERIFICATION REPORT : ---------------------------------------------------------- 9.

OBSERVATIN REPORT OF ELECTRICAL

11 : ---------------------------------------------------------- 10.
COMPONENTS

12 MATERIAL OF CONSTRUCTION REPORT : ---------------------------------------------------------- 11.

13 UTILITY REPORT : ---------------------------------------------------------- 12.

14 CRTICAL PROCESS INSTRUMENT REPORT : ---------------------------------------------------------- 13.

10 VISUAL INSPECTION : ---------------------------------------------------------- 14.

10.1 SITTING & LEVELING CHECK : ---------------------------------------------------------- 14.

10.2 CLENAING CHECK : ---------------------------------------------------------- 15.

10.5 UTILITY SERVICE CHECK : ---------------------------------------------------------- 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 / 2023

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

10.8 MANUAL DOCUMENT CHECK : ---------------------------------------------------------- 17.

INSTRUMENT CALIBRATION CHECK (IF
10.9 : ---------------------------------------------------------- 18.
APPLICABLE)

11 CONCLUSION : ---------------------------------------------------------- 19.

12 DEVIATION REPORTS PROCEDURE : ---------------------------------------------------------- 20 / 21

13 APPENDIX A - DQ DEVIATION REGISTER : ---------------------------------------------------------- 22

14 APPENDIX B – DEVIATION REPORT SHEET : ---------------------------------------------------------- 23

PRE – APPROVALS – EVALUATION / CORRECTIVE

13.1) : ---------------------------------------------------------- 24
ACTIONS

14 APPENDIX C – ATTACHMENTS REGSTER : ---------------------------------------------------------- 25

***********

1) ROLES & RESPONSIBILITIES

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 / 2023

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

Sr.
Department Responsibility
No.

To prepare qualification report and co-ordinate the entire qualification

1. Maintenance Officer
Activity.

To witness the qualification study and ascertain that the study is conducted
2. Quality Assurance Officer
As per the protocol.

3. Production Officer To execute qualification study in co-ordination with other departments.

4. Head maintenance To review the qualification documents.

5. Head quality Assurance To review and approve the qualification documents.

2) OBJECTIVE

 The objective of this protocol is to provide guidelines for the installation of the Zero Hold up Filter Press.

 To ensure that the equipment and system are installed in the liquid filtration Area and meet the specifications

as set out in the Design Qualification Document.

 To ensure that the various SOPs related to the system have been identified and listed.

 To ensure that all the critical instruments have been identified and documented for calibration.

3) SCOPE OF PROTOCOL

 This protocol will define the procedures, documentation, acceptance criteria and revalidation criteria to

establish that the equipment has been installed as required in the processing environment.

4) EQUIPMENT LOCATION
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 / 2023

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

The equipment is located at

Location PHARMAX ENGINEERS

Equipment ID

Serial No.

5) EXECUTION PROCEDURE

 The Installation 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

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 / 2023

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

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

 Equipment / documents required for completion of IQ

 Tool Kit

 Multi Meter

 Clamp Meter

 Spirit Level

 Techno Meter.

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 / 2023

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

6) CRITERIA FOR ACCEPTABILTY

 The successful execution of this protocol in accordance with the desired requirements as mentioned in the

specifications of the equipment will verify that the zero hold up filter press has been installed as per cGMP

requirements and is ready for operation.

7) INTERPRETATION OF RESULTS

 If the results of Installation 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 Installation Qualification is complete.

8) DOCUMENTATION CHECK

Sr. Documents Name/No. Date Sign to confirm

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 / 2023

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

9) DRAWING CHECK

 Compare the equipment with the relevant schematic and or as built general arrangement drawings and marks,

the drawings, which are verified. Ensure that any valves and instruments have identifications numbers which

correspond to those shown on the drawings. Write on the drawing the words “INSTALLATION

QUALIFICATION DRAWING CHECK” sign and date the marked-up prints when the checks are complete.

Also write the protocol title, reference number and the appendix number on the prints.

 Attach the marked-up prints to this protocol as an appendix.

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

1. General Assembly

2.

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 / 2023

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

10) INSTALLATION VERIFICATION REPORT

Sr. Checked sign by /

Check point acceptance criteria observations
No Date

Horizontal leveling of the

1 Perfectly Horizontal
equipment

Aligned vertically straight

with sufficient space for
2 Positioning of the equipment
maintenance

3 Floor balancing No vibrations

4 Identification Plate Manufacturer’s Name

5 Surface Finish Mirror

Any physical damage to the

No scratches or damage
6 equipment / floor or room
should be observed
walls

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

PAL PHARMA MACHINERY PAL PHARMA MACHINERY


11) OBSERVATION FOR ELECTRICAL COMPONENTS
Sr.
Check point
No
General method of the
1 electrical wiring
Electrical drawing
2
3 Emergency stop button
Switches for electrical
4 operation of the equipment
5 Control Panel
General method of the
6 electrical wiring
Prepared By.
PAL PHARMA MACHINERY
Name of the Customer: - PHARMAX ENGINEERS
Location : - VIKROLI , ANDHERI
PO NO : - VERBALLY
PO Date : - 15 / 02 / 2023
Model Name : - PPM / ZHSFP - 0808 (GMP MODEL)
Checked sign by /
acceptance criteria observations
Date
A. No loose hanging cables
B. Well-insulated electrical wiring.
C. Located in a safe place well
protected from water seepage
during machine or floor cleaning
and also safe for operator during
operation
Electrical drawing available
either pasted in the inside of the
circuit box or as in the
Manual.
Should be available at a place
easily accessible to the operator
when in need.
There should be one machine
switch for operating and one
separate power main switch.
Should be placed near the
machine at the operating cover
and mains to be connected to the
panel.
A. No loose hanging cables
B. Well-insulated electrical wiring.
C. Located in a safe place well
protected from water seepage
during machine or floor cleaning
and also safe for operator during
operation
Submitted By. Signed By. Company Stamp.
PAL PHARMA MACHINERY
 Name of the Customer: - PHARMAX ENGINEERS

Location : - VIKROLI , ANDHERI

PO NO : - VERBALLY

PO Date : - 15 / 02 / 2023

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

12) MATERIAL OF CONSTRUCTION REPORT

Sr. Provided
check point Acceptance criteria observations Checked sign by / Date
no Certificate
1 Main body (Shell) SS 316 Yes / No

2 Cartridge Assembly SS 316 Yes / No

3 Liquid Pipeline SS 316 Yes / No

4 Ball Valve SS 316 Yes / No

5 Sampler SS 316 Yes / No

6 Air Vent SS 316 Yes / No

7 Trolley SS 304 Yes / No

8 “I” Bolt / ring Nuts SS 304 Yes / No

9 Gasket / “O” Ring Silicon Food Grade Yes / No

___________________________________________________________________________________________________

___________________________________________________________________________________________________

___________________________________________________________________________________________________

___________________________________________________________________________________________________

___________________________________________________________________________________________________

___________________________________________________________________________________________________

___________________________________________________________________________________________________

___________________________________________________________________________________________________

___________________________________________________________________________________________________

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 / 2023

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

13) UTILITY REPORT

Sr.
Check Point Requirement Observations Checked sign by / Date
no

1 Voltage 380 – 460 V

2 Phase 3 Phase

3 Amperage 2 (No load)

4 Frequency 48 – 52 Hz.

5 Supply Wiring 2.5 Sq. mm / Core

6 Ear Thing Available

___________________________________________________________________________________________________

___________________________________________________________________________________________________

___________________________________________________________________________________________________

___________________________________________________________________________________________________

___________________________________________________________________________________________________

___________________________________________________________________________________________________

___________________________________________________________________________________________________

___________________________________________________________________________________________________

___________________________________________________________________________________________________

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 / 2023

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

14) CRITICAL PROCESS INSTRUMENT REPORT

 Any instrument used for inspection, testing or measuring the parameters, which affect the quality of process

or product, are considered as a critical process instrument.

 In Zero Hold up Filter Press process Cartridge Assembly (Filter Media) is critical parameters because it will

decide the filtration efficiency. So filter media used for filtration this parameter is included in the list of critical

part.

List of Filter Media details: -

Checked
Sr.
Description Details Observations sign by /
no
Date
1 Filter media type Polypropylene
2 Manufacturer N.M Enterprises
3 Model 415 A Polypropylene
Distilleries & Tonics / Chemical
4 Mode of purpose
(few type)
5 Filtration up to 5 micron
6 Weight 500 Gms. Per Sq. meter.
7 Specific Gravity 0.91
8 Safe Operating Temp.(°C) 90
9 Melting point Temp.(°C) 110
10 Resistance to Mineral Acids Excellent
11 Resistance to Alkaline Excellent
12 Resistance to Dry Heat Fair
13 Resistance to Moist Heat Fair
14 Resistance to Organic Acids Excellent
15 Resistance to Oxidizing Agent Good
16 Resistance to Abrasion Good
17 Test Certificate Available Yes / No

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 / 2023

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

15) VISUAL INSPECTION

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

15.1) Sitting & Leveling Check

 Objective

 To ensure that machine is correctly sited & leveled.

 Procedure

 Move machine to location

 Level the machine by keeping spirit level

 Acceptance Criteria

 Machine is at correct location. Machine is leveled in all plains.

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 / 2023

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

15.2) Cleaning Check

 Objective

 To ensure that the machine is cleaned.

 Procedure

 In accordance with manual, dismantle process area parts. Rinse and Clean all parts exposed surfaces

thoroughly. Degrease painted parts using soft cloth.

 Acceptance Criteria

 Contact parts are cleaned. Non-contact area is free of dust & dirt.

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 / 2023

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

15.3) Utility Services Check

 Objective

 Visually inspect the utilities and services installation for any damage that may compromise safety during

operation of the unit.

 Procedure

 Visual verification & co-relation with drawing

 Acceptance Criteria

 Parts are compatible with information in manual and drawing and prevalent site standards.

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 / 2023

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

15.4) Manual Document Check

 Objective

 To check whether the manual is present, accurate and correctly documented.

 Procedure

 Check the principle & instruction mentioned in the description column below are present in the manual.

 Acceptance Criteria

 All Documents Should be Present.

Sr No. Description Present Sign to confirm

1 Working Principle

2 Installation Instruction

3 Operational Instruction

4 Maintenance Schedule

5 Spare Part

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 / 2023

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

15.4) Instrument Calibration Check (If Applicable)

 Objective

 To calibrate the instruments required during the process.

 Procedure

 Calibrate the Instruments against the calibration set standard.

 Acceptance Criteria

 The specified Instruments should met the required calibration set standard

Sr.
Instrument Description Calibration Set Standard Result Sign to confirm
No.
1

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 / 2023

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

16) CONCLUSION

The data required for the Installation 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 –

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

____________________________________________________________________________________________________

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 / 2023

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

17) DEVIATION REPORTS PROCEDURE

During IQ, 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

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 / 2023

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

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 IQ protocol.

 This IQ document cannot be closed off until all deviations have been satisfactorily resolved.

18) APPENDIX A - IQ DEVIATION REGISTER

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 / 2023

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

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

19) APPENDIX B - DEVIATION REPORT SHEET

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 / 2023

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

Deviation No. Test Reference:

Details Of Deviation Noted:

Completed By: Date:

Evaluation Of Deviation / Corrective Actions To Be Taken:

Completed By: Date:

19.1) PRE – APPROVALS – EVALUATION / CORRECTIVE ACTIONS

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 / 2023

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

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 / 2023

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

20) APPENDIX C – ATTACHMENT REGISTERS

Department Name & Designation Date Signature

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

PAL PHARMA MACHINERY PAL PHARMA MACHINERY