CWH IOQ CA Final

Client: M/s. Dr. REDDY’S LABORATORIES LTD.
Project Name: FTO-11 CENTRAL WAREHOUSE
Supplier/ Manufacturer: M/S. SCON PROJECTS PVT. LTD.PUNE
Title: Addendum of Installation & Operational Qualification Protocol for Compressed Air
Distribution System
INSTALLATION & OPERATIONAL QUALIFICATION (IQ)
PROJECT: FTO-11, CWH
DOC NO: SCON/DRL/IQ/CA/CWH/001
PO NO: 4100103851
CUSTOMER:
M/s. Dr. REDDY’S LABORATORIES

FTO-11,Pydibheemavaram,Srikakulam (AP).
SUBMITTED BY:
M/s. SCON PROJECTS PVT LTD.

“SAMARTH HOUSE”, Survey No. 116/3/1, 3/3, 3/10, Pune-Bangalore
Highway, Near Shell Petrol Pump, Warje, Pune-411058.
Page 1 of 31
Distribution System
INSTALLATION & OPERATIONAL QUALIFICATION PRE-

APPROVAL
This document is prepared for by the documentation team of SCON Projects Pvt. Ltd. for the
FTO-11, CWH of M/s. Dr. Reddy’s Laboratories Ltd. Hence this document before being
effective shall be approved by M/s. Dr. Reddy’s Laboratories Ltd.
M/s. SCON PROJECTS PVT LTD:
Name Designation Signature Date
Prepared By
M/s. Dr. REDDY’S LABORATORIES LTD:
Reviewed By
Approved By
Page 2 of 31
Distribution System
TABLE OF CONTENTS
INSTALLATION QUALIFICATION
1.0 OBJECTIVE……………………………………………………………………..4
2.0 SCOPE……………………………………………………………………………4
3.0 RESPONSIBILTY……………………………………………………………….4
4.0 TRAINING DETAILS..........................................................................................5
5.0 SYSTEM DESCRIPTION………………………………………………………6
6.0 INSTALLATION VERIFICATION OF MAJOR COMPONENTS…………7
7.0 INSTRUMENT INBUILT CALIBRATION…………………………………..14
8.0 LIST OF ATTACHMENTS…………………………………………………….19
9.0 DEVIATION(S) IF ANY…………………………………………………………20
10. SUMMARY AND CONCLUSION……………………………………………..21
OPERATIONAL QUALIFICATION
1.0 OBJECTIVE……………………………………………………………………..22
2.0 SCOPE……………………………………………………………………………22
3.0 RESPONSIBILTY……………………………………………………………….22
4.0 GENERAL VERIFICATION..............................................................................23
5.0 IDENTIFICATION OF PROCEDURES………………………………………25
6.0 QRA COMPLIANCE VERIFICATION………………………………………26
7.0 LIST OF ATTACHMENTS…………………………………………………….27
8.0 DEVIATION(S) IF ANY………………………………………………………...28
9.0 SUMMARY AND CONCLUSION……………………………………………...29
Page 3 of 31
Distribution System
INSTALLATION QUALIFICATION
1.0 OBJECTIVE:
To establish documented evidence that all parts of Compressed Air Distribution System and its
accessories are installed as per manufacturer’s recommendation, design specification at Central
Warehouse of Dr. Reddy’s Laboratories Ltd., Formulations Unit 11.
2.0 SCOPE:
This IQ is applicable for installation qualification and its associated activities for the
qualification of the subject equipment/Components.
3.0 RESPONSIBILITY:
Sr. No. Organization Responsibility

- Preparation of IQ protocol
- Execution of IQ protocol
M/s. SCON
1
PROJECTS PVT.LTD - Providing all necessary documents for completing IQ
protocol execution
- Review and approval of IQ protocol
- Execution of IQ protocol
M/s. Dr. REDDY’S - Compilation and review of IQ report
2 LABORATORIES
- Review of IQ with respect to requirements, Regulatory
LTD.
Requirement, and cGMP requirements
- Approval of IQ and clearance for proceeding to next stage
Page 4 of 31
Distribution System
4.0 TRAINING DETAILS:

Organization Trainee Sign Trainer Sign
S. No. Name of the Trainee Remarks
Name & Date & Date
1.
2.
3.
4.
5.
6.
7.
8.
9.
Page 5 of 31
Distribution System
5.0 SYSTEM DESCRIPTION:
Compressed air distribution system is designed to distribute the compressed air with required
pressure to the Central Warehouse at Dr Reddy’s Laboratories Ltd, FTO-11 Located at
Pydibheemavaram.
Compressed air (CA) receiver for Non Onco expansion (Block-A) is located at service floor of
Non Onco block and connected to Existing Air Compressors. Compressed air pressure is
maintained through air compressor (Air-cooled Air compressor (522 CFM) and Water-cooled
Air Compressor (530CFM) of existing make & capacity which is connected to Dryer-1 and
Dryer-2, the dryer output air is connected to two receiver tanks. One is in the utilities and another
in service floor. After the utility block receiver tank, this compressed air distribution system is
tapped for Central Warehouse. CA can be used for operation of instruments and can also be
connected/used for process with addition of Air filter regulator (AFR) & 0.2µ filter. CA SS304
(25NB) Pipeline is laid from utility block to false ceiling. In between Ball Valves, Pressure
Gauges, Filter Housing & Air Filters (5µ, 1µ, 0.2µ) is installed. SS316 L OD EP tubes to be
considered for inside the clean room. Inside the clean room Ball Valves, Filters Housing, Air
Filters (0.2µ), Pressure Gauges & Air Filter Regulator is installed.
For Compressed Air Distribution System, following rooms/user points will be considered for
qualification as per approved Facility design qualification for Central Warehouse.
COMPRESSED AIR- INSTRUMENT / NON-PROCESS
Sr. Room Name Room Equipment Name / POU Number of

Pressure (Bar)
No. /Location Number / POU Description user points
Reverse Laminar Air
1. Sampling-1 F1G192 1 NLT 6
Flow Unit (FLP)
Page 6 of 31
Distribution System
Sr. Room Name Room Equipment Name / POU Number of

user points Pressure (Bar)
No. /Location Number / POU Description
Reverse Laminar Air

2. Sampling-2 F1G196 1 NLT 6
Flow Unit (NFLP)
3. Washroom F1G193 NA 1 NLT 6
4. Disinfectant F1G198 NA 1 NLT 6
6.0 INSTALLATION VERIFICATION OF MAJOR COMPONENTS:
 Compressed Air Pipe:
Sr. Component Verification Done By

Specifications Observations
No. s Methodology (Sign & Date)
Shubhalaxmi
1 Make Metals & Tubes
PVT.LTD.
2 Grade SS 304
3 Size 25 NB
 Compressed Air EP Tube:

1 Make Rensa Tubes
2 Grade SS 316 L
Sr. Component Specifications Observations Verification Done By
Page 7 of 31
Distribution System

1 Make Rensa Tubes

3 Size 25.4 NB
 Verification of Valves:

 Ball Valve
1 Make L&T
2 Size 25 NB
To be
3 Quantity Verified at
Site
 Ball Valve
1 Make L&T
2 Size 15 NB
To be
Site
 Ball Valve
1 Make GAMU
2 Size 25 NB
Quantity To be
3
Verified at
Page 8 of 31
Distribution System

 Ball Valve
1 Make L&T
Site
 Ball Valve

1 Make KIPTO
2 Size 25 NB
To be
Site
 AIR FILTER REGULATOR:

1 Make FESTO
2 Series D
3 Part Number 159633
4 Quantity 4 Nos.
 Verification Housing:
Page 9 of 31
Distribution System
Verification
Sr. Component Done By
Specifications Observations Methodolog
No. s (Sign & Date)
y
 Housing Details
DOMNICK
1 Make
HUNTER
2 MOC SS 316L
ZVAF-01K-
3 Model
BTEPD
1.
Sr. No. & To be Verified
4
Location at Site
2.
Verification
No. s (Sign & Date)
y
3.
4.
 Housing Details
1 Make PARKER
2 MOC SS 316L
ZVA-01K-
3 Model
BFE
4 Qty 3 Nos.
 Verification of Filters:
Page 10 of 31
Distribution System
Verification
No. s (Sign & Date)
y
 Filter Details (0.2µ)
1 Make Parker
2 Rating 0.2µ
3 Model ZHFT/KC
4 Qty. 5 Nos.
 Filter Details (1µ)
1 Make Parker
2 Rating 1µ
ZCPPK-
3 Model
1.0C
Verification
No. s (Sign & Date)
y
4 Qty. 1 No.
 Filter Details (5µ)
1 Make Parker
2 Rating 5µ
ZCPPK-
3 Model
005C
4 Qty. 1 No.
 Verification of Pressure Gauges:
Page 11 of 31
Distribution System
Verification
No. s (Sign & Date)
y
 Pressure Gauge
1 Make ITEC
2 Range 0 to 10 Bar
3 Qty. 4 Nos.
1.
2.
To be Verified
4 Sr.No.
at Site
3.
4.
 Pressure Gauge
1 Make SHREEJI
Verification
No. s (Sign & Date)
y
0 to 10
2 Range
KG/CM²
3 Qty. 3 Nos.
1.
To be Verified
4 Sr. No. 2.
at Site
3.
 Pressure Gauge
Page 12 of 31
Distribution System
Verification
No. s (Sign & Date)
y
 Pressure Gauge
1 Make ITEC
1 Make Baumer
0 to 10
2 Range
KG/CM²
3 Qty. 3 Nos.
1.
To be Verified
4 Sr.No. 2.
at Site
3.
 Pressure Gauge
1 Make Arbuda
2 Range 0 to 10 Bar
3 Qty. 4 Nos.
1.
To be Verified
4 Sr.No. 2.
at Site
3.
Verification
No. s (Sign & Date)
y
4.
 Pressure Gauge
Page 13 of 31
Distribution System
Verification
No. s (Sign & Date)
y
 Pressure Gauge
1 Make ITEC
1 Make FESTO
2 Range 0 to 16 Bar
3 Qty. 4 Nos.
Checked By:
(Sign & Date)
Page 14 of 31
Distribution System
7.0 Instrument Inbuilt Calibration:

Note: This section shall be filled by User as per respective SOP.
Instructions:
☛ Instrument criticality assessment shall be done based on following questions.
1. Does the instrument have direct impact on the quality of product i.e., it controls or
monitors the CQA/CPP?
2. Does the instrument have impact on the process or system performance in terms of
control and functionality?
3. Is the instrument data documented in quality records?
4. Is the instrument related to any of the safety application?
If the answer is ‘Yes’ to all or any one of the above questions, then the instrument shall be
categorized as ‘Critical Instrument’.
List out the measuring instruments provided on the equipment / system / instrument and classify
them as Critical, Non-Critical and Indicative as per DRL SOP: ________________________.
Page 15 of 31
Title: Addendum of Installation & Operational Qualification Protocol for Compressed Air Distribution System
Section A: Identification & Classification:

Provide
applicable Critical (C ) / Manufacturer’s
S. Instrument Used to Instrume ID Code
question no Non-Critical (NC) Make Sr. No. (if
No. Description measure nt Range No.
( 1 to 4) or and Indicative (I ) /Periodicity available)
NA
Page 16 of 31
Provide
applicable Critical (C ) / Manufacturer’s
S. Instrument Used to Instrume ID Code
question no Non-Critical (NC) Make Sr. No. (if
No. Description measure nt Range No.
( 1 to 4) or and Indicative (I ) /Periodicity available)
NA
Checked By Checked By Verified By Approved by

(Engineering) (User) (Qualification team) (Quality Assurance)
Sign and Date
Page 17 of 31
Section B: Instrument calibration details:
Carryout the calibration of critical / non critical /Indicative instrument(s) and record the details in the format given below:
Details of the Standard
ID Code/ Calibratio
Instrument Calibratio Calibration Instrument used for calibration
Control n
description n Due On report No. Calibration due
No. Done On Name/ID No. Calibrated on
on
Instrument ID Code/ Calibratio Calibratio Calibration Details of the Standard

description Control n n Due On report No. Instrument used for calibration
Page 18 of 31
Calibration due
No. Done On Name/ID No. Calibrated on
on
Remarks:
Checked By (Engineering): Verified By (Qualification team):
Date: Date:
Page 19 of 31
Distribution System
8.0 LIST OF ATTACHMENTS:
No of
S. No. Attachment Description Attachment no
pages
Compiled By: Checked By:

(Sign & Date) (Sign & Date)
Page 20 of 31
Distribution System
9.0 DEVIATION(S) IF ANY:
9.1 ACTIONS, IF ANY:
Page 21 of 31
Distribution System
10.0 SUMMARY AND CONCLUSION:
Page 22 of 31
Distribution System
OPERATIONAL QUALIFICATION
1.0 OBJECTIVE:
 To verify that the system consistently operates within a specified set of parameters under
normal operating conditions and/or range of intended use.
 To assure that the system operation is adequate to support the process for which the
system is intended.
 To ensure the completeness and adequacy of Standard Operating Procedures / Preventive
maintenance Procedures.
2.0 SCOPE:
This OQ is applicable for operational qualification and its associated activities for the
qualification of the subject equipment / Components.
During Operational qualification, following shall be considered under general and Functional
verification but not limited to:
 Pneumatic Test for Piping
3.0 RESPONSIBILITIES:
Sr.
Organization Responsibility
No.
2.1.1 Preparation of OQ protocol
2.1.2 Execution of OQ protocol
M/s. SCON PROJECTS
1
PVT.LTD 2.1.3 Providing all necessary documents for completing OQ
protocol execution
Page 23 of 31
Distribution System
2.1.4 Review and approval of OQ protocol

2.1.5 Execution of OQ protocol
2.1.6 Compilation and review of OQ report
M/s. Dr. REDDY’S
2
LABORATORIES LTD. 2.1.7 Review of OQ with respect to requirements, Regulatory
Requirement, and cGMP requirements
2.1.8 Approval of OQ and clearance for proceeding to next stage
4.0 GENERAL VERIFICATION:

4.1 Pneumatic Test for Piping
Purpose:
To ensure and prove the tightness of the joints and ensure that there are no leaks in the
piping
Test procedure:
 Prior to start of pressure testing, flushing to be done by using air and pipes shall be
free from dirt and other foreign materials.
 Temporary connections shall be given on both ends of the SS Pipes.
 Air vent point shall be plugged.
 Piping shall be pressurized gradually by using mechanical pump / Hand Pump.
 Pressure gauges shall be fixed on the temporary connection of the pipes.
 The test pressure shall be not less than 1.1 times and not more than 1.33 of the
system design pressure.
 The test duration shall be minimum 01 hour unless specified test pressure.
 While the system is under pressure, a careful inspection shall be made for all pipes
and joints and if any leak in joints or evidence of defective pipe or fitting is found,
Page 24 of 31
Distribution System
the defective work shall be corrected immediately by replacing defective parts with
new joints and materials.
 After the correction is made the pressure test shall be repeated for the piping
network.
 After the successful completion of pressure testing all temporary fittings and gauges
to be removed and pipe ends shall be plugged with dummy.
 Test Result enclosed with document.
Acceptance Criteria:
 No leakage or pressure drop shall be observed.
Pressure Time Instrument Used

Test
Duration
Pressure Instrument Name
:
:
Start
Start
Pressure Instrument ID
Time:
:
Calibrated on:
End Calibration Due
End on:
Pressure
Time:
: Calibration
Certificate
Details:
Test Result
(Pass/Fail)
Performed by: Verified by:
Sign & date Sign & date
Page 25 of 31
Distribution System
5.0 IDENTIFICATION OF PROCEDURES:

 Identify and list down relevant procedures required for the equipment/ system.
 Put “√” mark wherever a procedure is required or mention ‘if not applicable in their
related box “□” & “NA” in remarks.
 Mention expected items/procedure in “Remark” column i.e., machine change parts
dismantling/cleaning/any important aspect etc.
 The section shall be executed by DRL representative.
Sr. Remarks Identified By

Document required Proposed Title
No. (Expected to cover) (DRL)
Operation
1.
Procedure □
2. Cleaning Procedure □
Preventive
3. Maintenance
Procedure
□
Calibration
4. procedure □
Other Procedures
(if any)
5. _______________ □
___
REMARKS:
Checked By:(Sign & Date)
Page 26 of 31
Distribution System
6.0 QRA COMPLIANCE VERIFICATION:
Verification Section Checked By DRL

S.NO QRA Requirements Remarks
in OQ (Sign & Date)
Comments (If Any):
Reviewed By:
(Sign & Date)
Page 27 of 31
Distribution System
7.0 LIST OF ATTACHMENTS:
No of
S. No. Attachment Description Attachment no
pages
Page 28 of 31
Distribution System
Compiled By: Checked By:

(Sign & Date) (Sign & Date)
8.0 DEVIATION(S) IF ANY:
8.1 ACTIONS, IF ANY:
Page 29 of 31
Distribution System
9.0 SUMMARY AND CONCLUSION:
Page 30 of 31
Distribution System
INSTALLATION & OPERATINAL QUALIFICATION POST APPROVAL
M/s. SCON PROJECTS PVT LTD:
Prepared By
M/s. Dr. REDDY’S LABORATORIES LTD:
Reviewed By
Approved By
Page 31 of 31

CWH IOQ CA Final

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

CWH IOQ CA Final

Uploaded by

Copyright:

Available Formats

Client: M/s. Dr. REDDY’S LABORATORIES LTD.

Project Name: FTO-11 CENTRAL WAREHOUSE

Supplier/ Manufacturer: M/S. SCON PROJECTS PVT. LTD.PUNE

INSTALLATION & OPERATIONAL QUALIFICATION (IQ)

PROJECT: FTO-11, CWH

DOC NO: SCON/DRL/IQ/CA/CWH/001

M/s. Dr. REDDY’S LABORATORIES

M/s. SCON PROJECTS PVT LTD.

Project Name: FTO-11 CENTRAL WAREHOUSE

Supplier/ Manufacturer: M/S. SCON PROJECTS PVT. LTD.PUNE

INSTALLATION & OPERATIONAL QUALIFICATION (IQ)

INSTALLATION & OPERATIONAL QUALIFICATION PRE-

M/s. SCON PROJECTS PVT LTD:

Name Designation Signature Date

M/s. Dr. REDDY’S LABORATORIES LTD:

Name Designation Signature Date

Project Name: FTO-11 CENTRAL WAREHOUSE

Supplier/ Manufacturer: M/S. SCON PROJECTS PVT. LTD.PUNE

INSTALLATION & OPERATIONAL QUALIFICATION (IQ)

Project Name: FTO-11 CENTRAL WAREHOUSE

Supplier/ Manufacturer: M/S. SCON PROJECTS PVT. LTD.PUNE

INSTALLATION & OPERATIONAL QUALIFICATION (IQ)

Sr. No. Organization Responsibility

Project Name: FTO-11 CENTRAL WAREHOUSE

Supplier/ Manufacturer: M/S. SCON PROJECTS PVT. LTD.PUNE

INSTALLATION & OPERATIONAL QUALIFICATION (IQ)

4.0 TRAINING DETAILS:

Project Name: FTO-11 CENTRAL WAREHOUSE

Supplier/ Manufacturer: M/S. SCON PROJECTS PVT. LTD.PUNE

INSTALLATION & OPERATIONAL QUALIFICATION (IQ)

5.0 SYSTEM DESCRIPTION:

COMPRESSED AIR- INSTRUMENT / NON-PROCESS

Sr. Room Name Room Equipment Name / POU Number of

Project Name: FTO-11 CENTRAL WAREHOUSE

Supplier/ Manufacturer: M/S. SCON PROJECTS PVT. LTD.PUNE

INSTALLATION & OPERATIONAL QUALIFICATION (IQ)

Sr. Room Name Room Equipment Name / POU Number of

Reverse Laminar Air

3. Washroom F1G193 NA 1 NLT 6

4. Disinfectant F1G198 NA 1 NLT 6

6.0 INSTALLATION VERIFICATION OF MAJOR COMPONENTS:

 Compressed Air Pipe:

Sr. Component Verification Done By

 Compressed Air EP Tube:

Sr. Component Verification Done By

1 Make Rensa Tubes

Sr. Component Specifications Observations Verification Done By

Project Name: FTO-11 CENTRAL WAREHOUSE

Supplier/ Manufacturer: M/S. SCON PROJECTS PVT. LTD.PUNE

INSTALLATION & OPERATIONAL QUALIFICATION (IQ)

Sr. Component Verification Done By

1 Make Rensa Tubes

Sr. Component Verification Done By

Project Name: FTO-11 CENTRAL WAREHOUSE

Supplier/ Manufacturer: M/S. SCON PROJECTS PVT. LTD.PUNE

INSTALLATION & OPERATIONAL QUALIFICATION (IQ)

Sr. Component Verification Done By

Sr. Component Verification Done By

 AIR FILTER REGULATOR:

3 Part Number 159633

Project Name: FTO-11 CENTRAL WAREHOUSE

Supplier/ Manufacturer: M/S. SCON PROJECTS PVT. LTD.PUNE

INSTALLATION & OPERATIONAL QUALIFICATION (IQ)

Project Name: FTO-11 CENTRAL WAREHOUSE