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DARSH PHARMACHEM PVT. LTD.

VIL: VARSOLA, MAHEMDABAD


Page 1 of 12
DESIGN QUALIFICATION PROTOCOL
CUM REPORT
Equipment ID Protocol Number
Revision No. 00 Effective Date

DESIGN QUALIFICATION
PROTOCOL CUM REPORT
OF
BRINE PLANT
DARSH PHARMACHEM PVT. LTD.
VIL: VARSOLA, MAHEMDABAD
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DESIGN QUALIFICATION PROTOCOL
CUM REPORT
Equipment ID Protocol Number
Revision No. 00 Effective Date

TABLE OF CONTENTS

1. APPROVAL SHEET…………………………………………………………… 3

2. REVISION HISTORY………………………………………………………… 3

3. TITLE…………………………………………………………………………… 4

4. OBJECTIVE…………………………………………………………………….... 4

5. SCOPE…………………………………………………………………………….. 4

6. RESPONSIBILITY……………………………………………………………….. 4

7. VALIDATION TEAM……………………………………………………………. 4

8. REASON FOR DESIGN QUALIFICATION …………………………………… 5

9. PREREQUISITES …………………………………………………………….… 5

10. SYSTEM DESCRIPTION ………………………………………….…………… 6

11. EVALUATION OF REQUIREMENTS………………………………………… 7

12. DEFICIENCY AND CORRECTIVE ACTION REPORT …………………… 8

13. FINAL REPORT …………………………………………………..…………… 9

14. REFERENCE DOCUMENTS ………………………………………………… 10

15. APPENDIX……………………………………………………………………… 11

16. ATTACHMENTS ……………………………………………………………… 12


DARSH PHARMACHEM PVT. LTD.
VIL: VARSOLA, MAHEMDABAD
Page 3 of 12
DESIGN QUALIFICATION PROTOCOL
CUM REPORT
Equipment ID Protocol Number
Revision No. 00 Effective Date

1.0 APPROVAL SHEET

The Design Qualification Protocol of the System/ Equipment/Instrument shall be prepared,


reviewed and approved by the concerned personnel’s. It shall be signed and dated as shown below.

Prepared By

Name Designation Signature Date

Reviewed By

Name Designation Signature Date

Approved By

Name Designation Signature Date

2.0 REVISION HISTORY

Reason for Revision/Change


Revision Revision Date Revised By
Request
00 NA New Documents NA
DARSH PHARMACHEM PVT. LTD.
VIL: VARSOLA, MAHEMDABAD
Page 4 of 12
DESIGN QUALIFICATION PROTOCOL
CUM REPORT
Equipment ID Protocol Number
Revision No. 00 Effective Date

3.0 TITLE

It describes the Design qualification Protocol cum Report of the Brine Plant qualified.

4.0 OBJECTIVE

The purpose of this document is to provide design qualification for Brine Plant. This document
provides evidence that the equipment is designed as per user requirement specification.

5.0 SCOPE

The scope of this Design Qualification Protocol cum Report of the Brine Plant is applicable at Utility
Plant-01, located in Darsh Pharmachem Pvt. Ltd., Varsola.

6.0 RESPONSIBILITIES

The responsibilities of different departments involved in Execution of Design Qualification of Brine


Plant are as below:
 Engineering: Responsible for preparation & review of the Design Qualification Protocol cum
report and perform the Operational checks.
 Production: Responsible for review of the design Qualification Protocol cum Report.
 Quality Assurance: Responsibility for review and finally approve the design qualification
protocol cum report.

7.0 VALIDATION TEAM

This shall mention the details of personnels from different departments involving the qualification
study.
Name Designation Signature Date
DARSH PHARMACHEM PVT. LTD.
VIL: VARSOLA, MAHEMDABAD
Page 5 of 12
DESIGN QUALIFICATION PROTOCOL
CUM REPORT
Equipment ID Protocol Number
Revision No. 00 Effective Date

8.0 REASON FOR DESIGN QUALIFICATION


The reason for preparing this document is:

Please click any one (or multiple) option(s) from the following ():

New or refurbished premises 


Purchase Utility Systems 
Purchase of processing equipment 
Custom built equipment 
Bespoke or user configured computer systems 
Other (Specify) 

9.0 PREREQUISITES

Sr. Availability
Prerequisite Location Checked by
No. (Y/N)
Technical information provided
1
by the vendor
2 User requirements

3 Technical specification (optional)

4 Other (Specify)

Y: Yes N: No
DARSH PHARMACHEM PVT. LTD.
VIL: VARSOLA, MAHEMDABAD
Page 6 of 12
DESIGN QUALIFICATION PROTOCOL
CUM REPORT
Equipment ID Protocol Number
Revision No. 00 Effective Date

10.0 SYSTEM DESCRIPTION

Name Of Equipment :
Make :
Model :
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

Prepared By: ____________________ Date: ________________

Reviewed By: ____________________ Date: ________________


DARSH PHARMACHEM PVT. LTD.
VIL: VARSOLA, MAHEMDABAD
Page 7 of 12
DESIGN QUALIFICATION PROTOCOL
CUM REPORT
Equipment ID Protocol Number
Revision No. 00 Effective Date

11.0 EVALUATION OF REQUIREMENTS


The proposed design meets the
Sr. Description of
performance and cGMP Checked by
No. requirement
requirements (Y/N/NA)

Y: Yes N: No NA: Not applicable

Prepared By: ____________________ Date: ________________

Reviewed By: ____________________ Date: ________________

12.0 DEFICIENCY AND CORRECTIVE ACTION REPORT


DARSH PHARMACHEM PVT. LTD.
VIL: VARSOLA, MAHEMDABAD
Page 8 of 12
DESIGN QUALIFICATION PROTOCOL
CUM REPORT
Equipment ID Protocol Number
Revision No. 00 Effective Date

Description of deficiency and its classification*@


Sr. Deficiency Category

Recommended corrective action to be taken by supplier (for category B deficiency)


Sr. Recommended corrective action Responsibility

Recommended corrective action to be taken by user (for category C deficiency)


Sr. Recommended corrective action Responsibility

* Category A: Design is accepted with deficiency


Category B: Conditional acceptance of equipment, deficiency to be corrected either by supplier
or user
Category C: Deficiency to be rectified before proceeding further
@ In case of any developmental requirements, please attach relevant annexure
Developmental work required/Not required. (If required, refer annexure No.__________)

Prepared By: ____________________ Date: ________________

Reviewed By: ____________________ Date: ________________

13.0 FINAL REPORT


1. Summary
2. Evaluation
DARSH PHARMACHEM PVT. LTD.
VIL: VARSOLA, MAHEMDABAD
Page 9 of 12
DESIGN QUALIFICATION PROTOCOL
CUM REPORT
Equipment ID Protocol Number
Revision No. 00 Effective Date

3. Certification

Prepared By: ____________________ Date: ________________

Reviewed By:____________________ Date: ________________

14.0 REFERENCE DOCUMENTS

Sr. No. Title Location


1 Drawings provided by _________ --
Design qualification document provided by
2 --
________________
DARSH PHARMACHEM PVT. LTD.
VIL: VARSOLA, MAHEMDABAD
Page 10 of 12
DESIGN QUALIFICATION PROTOCOL
CUM REPORT
Equipment ID Protocol Number
Revision No. 00 Effective Date

Prepared By: ____________________ Date: ________________

Reviewed By:___________________ Date: ________________

15.0 APPENDIX

Sr. No. Abbreviation Description


1 MOC Material of Construction
2 MM Millimeter
3 MS Mild Steel
4 SS Stainless steel
5
DARSH PHARMACHEM PVT. LTD.
VIL: VARSOLA, MAHEMDABAD
Page 11 of 12
DESIGN QUALIFICATION PROTOCOL
CUM REPORT
Equipment ID Protocol Number
Revision No. 00 Effective Date

6
7
8
9
10
11

Prepared By: ____________________ Date: ________________

Reviewed By:___________________ Date: ________________


DARSH PHARMACHEM PVT. LTD.
VIL: VARSOLA, MAHEMDABAD
Page 12 of 12
DESIGN QUALIFICATION PROTOCOL
CUM REPORT
Equipment ID Protocol Number
Revision No. 00 Effective Date

16.0 ATTACHMENTS

Sr. No. Description


 1  Reference Drawing of Brine Plant of Jyoti Engineering
 2  Qualification Documents of Brine Plant of Jyoti Engineering
   
   
   
   
   
   
   
   
   
   
   
   
   
   

Prepared By: ____________________ Date: ________________

Reviewed By:___________________ Date: ________________