DQ Report For Brine

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
Page 2 of 12
CUM REPORT
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

Page 3 of 12
CUM REPORT
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
Approved By
2.0 REVISION HISTORY
Reason for Revision/Change

Revision Revision Date Revised By
Request
00 NA New Documents NA
Page 4 of 12
CUM REPORT
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.
Page 5 of 12
CUM REPORT
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
Page 6 of 12
CUM REPORT
10.0 SYSTEM DESCRIPTION
Name Of Equipment :
Make :
Model :
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
Prepared By: ____________________ Date: ________________
Reviewed By: ____________________ Date: ________________

Page 7 of 12
CUM REPORT
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

Page 8 of 12
CUM REPORT
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
Page 9 of 12
CUM REPORT
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 --
________________
Page 10 of 12
CUM REPORT
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
Page 11 of 12
CUM REPORT
6
7
8
9
10
11
Prepared By: ____________________ Date: ________________
Reviewed By:___________________ Date: ________________

Page 12 of 12
CUM REPORT
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: ________________

DQ Report For Brine

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DARSH PHARMACHEM PVT. LTD.

VIL: VARSOLA, MAHEMDABAD

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

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

1.0 APPROVAL SHEET

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

Name Designation Signature Date

Name Designation Signature Date

Name Designation Signature Date

2.0 REVISION HISTORY

Reason for Revision/Change

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

7.0 VALIDATION TEAM

8.0 REASON FOR DESIGN QUALIFICATION

New or refurbished premises 

3 Technical specification (optional)

10.0 SYSTEM DESCRIPTION

Prepared By: ____________________ Date: ________________

Reviewed By: ____________________ Date: ________________

11.0 EVALUATION OF REQUIREMENTS

Y: Yes N: No NA: Not applicable

Prepared By: ____________________ Date: ________________

Reviewed By: ____________________ Date: ________________

12.0 DEFICIENCY AND CORRECTIVE ACTION REPORT

Description of deficiency and its classification*@

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

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

* Category A: Design is accepted with deficiency

Prepared By: ____________________ Date: ________________

Reviewed By: ____________________ Date: ________________

13.0 FINAL REPORT

Prepared By: ____________________ Date: ________________

Reviewed By:____________________ Date: ________________

14.0 REFERENCE DOCUMENTS

Sr. No. Title Location

Prepared By: ____________________ Date: ________________

Reviewed By:___________________ Date: ________________

Sr. No. Abbreviation Description

Prepared By: ____________________ Date: ________________

Reviewed By:___________________ Date: ________________

Sr. No. Description

Prepared By: ____________________ Date: ________________

Reviewed By:___________________ Date: ________________

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