Installation Qualification Protocol Document Title: IQ of Laminar Air Flow Unit

Document No:
XX PHARMACEUTICALS LIMITED
117 Adams Street, Brooklyn, NY 11201, USA
Location:

INSTALLATION QUALIFICATION PROTOCOL/REPORT

LAMINAR AIR FLOW UNIT OF STERILE AREA OF CEPHALOSPORIN

BLOCK
DOCUMENT NO. :
VERSION NO. :
DATE OF ISSUE :

XX PHARMACEUTICALS LIMITED
117 Adams Street, Brooklyn, NY 11201, USA

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 Installation Qualification Protocol Document Title: IQ of Laminar Air Flow Unit
Document No:
XX PHARMACEUTICALS LIMITED
117 Adams Street, Brooklyn, NY 11201, USA
Location:

Approval of Document:

Prepared By:
Name: Rex Barrett
Designation: Manager, Validation
Department: Engineering
Signature & Date:

Checked By:
Name: Caleb Hines
Designation: Manager, Engineering
Department: Engineering
Signature & Date:

Agreed By:
Name: Milton Alvarado
Designation: Manager, Engineering
Department: Engineering
Signature & Date:

Approved By:
Name: Joanna Warner
Designation: Manager, Quality Assurance
Department: Quality Assurance
Signature & Date:

CONTENTS

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 Installation Qualification Protocol Document Title: IQ of Laminar Air Flow Unit
Document No:
XX PHARMACEUTICALS LIMITED
117 Adams Street, Brooklyn, NY 11201, USA
Location:

Page
1 DOCUMENT DESCRIPTION 4
2 PURPOSE 4
3 SCOPE 4
4 RESPONSIBILITIES 4
5 BACKGROUND
5. Project Description & Related issues 4
1
5. Purchasing Information 4
2
6 SYSTEM DESCRIPTION 5

7 VERIFICATION OF INSTALLATION 5

8 DEVIATION AND FAILURE INVESTIGATION SUMMARY 7

9 ATTACHMENTS 8

10 REPORT SUMMARY 9

11 CONCLUSION 10

12 VERIFICATION OF COMPLETION 11

13 REPORT APPROVAL 12

14 ABBREVIATION 13
.

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 Installation Qualification Protocol Document Title: IQ of Laminar Air Flow Unit
Document No:
XX PHARMACEUTICALS LIMITED
117 Adams Street, Brooklyn, NY 11201, USA
Location:

1. DOCUMENT DESCRIPTION

Document No. :
Version No. :
Date :
Description :

2. PURPOSE
To verify and document that the Laminar Air Flow Unit of Sterile Area of Cephalosporin Block is designed, built
and installed according to XX Pharmaceuticals Limited’s demand and manufacturer specifications and that
documentation is compiled to verify the integrity of the installation.

3. SCOPE
This Installation Qualification (IQ) is to be performed against agreed acceptance criteria on the Laminar Air
Flow Unit installed above the turn table after Depyrogenation Tunnel in Room of Sterile Production floor of
Cephalosporin Block. The scope will include assessment of equipment design and installation, connection of
utilities, presence and function of instruments.

4. RESPONSIBILITIES
4.1 Preparation of protocol
Engineering Department.
4.2 Executing the protocol
Engineering department or other suitably qualified staff allocated from the site or contracted specialists as
appropriate.
4.3 Providing documentation on the equipment
Related departments i.e. Engineering Production, Validation or other appropriate departments and
manufacturer
4.4 Data documentation and preparation of the report
Raw data documentation is the responsibility of those conducting the validation. Preparation of the report and
incorporation of data will be the responsibility of the Engineering Department.

5. BACKGROUND
5.1 Project Description & Related issues
This Laminar Air Flow Unit has been installed in the year 20XX in the sterile production area of Cephalosporin
Block for dispensing of raw materials.
5.2 Purchasing Information

Item Brand Origin

Manufacturer GUSU
Local Agent Precisa Techno Trade
CHINA
Model Number Standard
Serial No. N.A
6. SYSTEM DESCRIPTION

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 Installation Qualification Protocol Document Title: IQ of Laminar Air Flow Unit
Document No:
XX PHARMACEUTICALS LIMITED
117 Adams Street, Brooklyn, NY 11201, USA
Location:

A Laminar Air Flow Unit is used to provide unidirectional air flow. Grade A is ensured under LAF using H14
HEPA filter. A blower is used to circulate the air. The air flow direction of this LAF is vertical. There is a
differential pressure gauge to see the differential pressure across the filters which indicate the blockage of
filters.

7. VERIFICATION OF INSTALLATION
7.1 Design Documentation
7.1.1 General Characteristics

SL. Verification of compliance with Acceptance

No Characteristics Acceptance Criteria Criteria
. Actual Pass/ Initial Date
Fail
1 Identification Number CPRD-098-001

2 Machine Name LAMINAR AIR FLOW UNIT

3 Manufacturer GUSU

4 Supplier Precisa Techno Trade

5 Model or Type GMP Standard

6 Serial Number N.A

Observations:

Completion of assessment verified:

Name ___________________ Designation____________________ Signature ____________ Date __________

7.1.2 Engineering Specifications

Sl. Verification of Compliance with Acceptance
No Description Acceptance Criteria Criteria
. Actual Pass/ Initial Date
Fail
Length = 1225 mm

1 Dimension Width = 1225 mm

Height = 600 mm

Material of
2 SS304
construction

3 Surface finish Mirror polished

4 Final Filter HEPA (H14)

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 Installation Qualification Protocol Document Title: IQ of Laminar Air Flow Unit
Document No:
XX PHARMACEUTICALS LIMITED
117 Adams Street, Brooklyn, NY 11201, USA
Location:

Sl. Verification of Compliance with Acceptance

No Description Acceptance Criteria Criteria
. Actual Pass/ Initial Date
Fail
Manufacturer of
5 Mayair
HEPA filters
6 No. of HEPA filters 2 sets

7 DOP/PAO test port Present

8 Magnehelic Gauges 01 no.

Power: 1.5 KW

Voltage: 220 – 240 V

9 Motor Specification
Frequency: 50 Hz

Phase: Single

Observations:

Completion of assessment verified:

Name ____________________ Designation _________________ Signature ______________ Date __________

7.2 Instruments verification

Class

Sl. Calibration Initial &

Name & ID Function
No. Required Yes/No Date

Magnehelic Gauge Indicates differential

01 pressure across 3 Yes
ID:
HEPA filter.

Observation:

Completion of assessment verified by:

Name __________________ Designation___________________ Signature ______________ Date __________

7.3 Utility Verification

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 Installation Qualification Protocol Document Title: IQ of Laminar Air Flow Unit
Document No:
XX PHARMACEUTICALS LIMITED
117 Adams Street, Brooklyn, NY 11201, USA
Location:

Sl. Verification of Compliance with Acceptance

Acceptance
No Description Criteria
Criteria
. Actual Pass/ Initial Date
Fail
Voltage 220 – 240 V

1 Power Phase Single

Frequency 50 Hz

Observation:

Completion of assessment verified by:

Name ____________________ Designation___________________ Signature ______________ Date ___________

8. DEVIATION AND FAILURE INVESTIGATION SUMMARY

In the column below record any deviations or failures that occurred during the IQ exercise.

Deviation/
Description and Assessment of Impact on Validation Initial Date
Failure No.

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 Installation Qualification Protocol Document Title: IQ of Laminar Air Flow Unit
Document No:
XX PHARMACEUTICALS LIMITED
117 Adams Street, Brooklyn, NY 11201, USA
Location:

9. ATTACHMENTS
Attached data are listed in the table below:
Attachmen
Description of Attachment Initial Date
t
No.

Attached document verified by:

Name _____________________ Designation __________________ Signature______________ Date____________

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 Installation Qualification Protocol Document Title: IQ of Laminar Air Flow Unit
Document No:
XX PHARMACEUTICALS LIMITED
117 Adams Street, Brooklyn, NY 11201, USA
Location:

10. REPORT SUMMARY

The report summary of Installation Qualification of Laminar Air Flow Unit of Cephalosporin Block is as follows:

Sl. Acceptance Criteria Met Deviation found

Checking parameter
No. Yes No Yes No

1 General Specification verification

2 Engineering Specification verification

3 Instruments verification

4 Utility verification

Comments:

Performed by:

Name …………………………. Designation …………………… Signature ……………………... Date ……………..

Verified by:

Name …………………………. Designation …………………… Signature ……………………... Date ……………..

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 Installation Qualification Protocol Document Title: IQ of Laminar Air Flow Unit
Document No:
XX PHARMACEUTICALS LIMITED
117 Adams Street, Brooklyn, NY 11201, USA
Location:

11. CONCLUSION

The Installation Qualification of Laminar Air Flow Unit of Cephalosporin Block Complies / Does Not Comply

with the acceptance criteria taken above and the results obtained have been filled up in the respective table of

each test.

The Laminar Air Flow Unit of Cephalosporin Block is / is not qualifying the Installation Qualification test as per

this Protocol. Hence, the system can be / cannot be used for Operational Qualification.

Performed by:

Name …………………………. Designation …………………… Signature ……………………... Date ……………..

Verified by:

Name …………………………. Designation …………………… Signature ……………………... Date ……………..

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 Installation Qualification Protocol Document Title: IQ of Laminar Air Flow Unit
Document No:
XX PHARMACEUTICALS LIMITED
117 Adams Street, Brooklyn, NY 11201, USA
Location:

12. VERIFICATION OF COMPLETION

Department Name Designation Signature Date

Comments:

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 Installation Qualification Protocol Document Title: IQ of Laminar Air Flow Unit
Document No:
XX PHARMACEUTICALS LIMITED
117 Adams Street, Brooklyn, NY 11201, USA
Location:

13. REPORT APPROVAL

Name Designation Signature & Date

Milton Alvarado Manager, Engineering

Laurie Ramirez Manager, Plant

Joanna Warner Manager, Quality Assurance

14. ABBREVIATIONS

Short Form Full meaning

N.A Not Available

N/A Not Applicable

LAF Laminar Air Flow

HEPA High Efficiency Particulate Air

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