PROTOCOL No.

:
FACILITY QUALIFICATION
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Effective Date:

FACILITY QUALIFICATION

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Format No.
 FACILITY QUALIFICATION PROTOCOL No.:
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CONTENTS
S.No. Title of sections Page No.
1.0 Pre-approval Protocol
2.0 Objective

3.0 Scope

4.0 Reason for Facility Qualification

5.0 Responsibility

6.0 USER REQUIREMENT SPECIFICATION (URS)

6.1 Objective

6.2 Reason for URS

6.3 Requirements

6.4 Attachments

6.5 Recommendations/ Conclusion

6.6 Post approval

7.0 DESIGN QUALIFICATION (DQ)

7.1 Objective

7.2 Reason for DQ

7.3 Requirements

7.4 Attachments

7.5 Expected Documents and Drawings

7.6 Recommendations/ Conclusion

7.7 Post approval

8.0 INSTALLATION QUALIFICATION (IQ)

8.1 Objective

8.2 Reason for IQ

8.3 Requirements

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S. No. Title of sections Page No.

8.4 Attachments

8.5 Expected Documents and Drawings

8.6 Deviations/ Changes (if any)

8.7 Recommendations/ Conclusion

8.8 Post approval

9.0 OPERATION QUALIFICATION (OQ)

9.1 Objective

9.2 Reason for OQ

9.3 Training

9.4 Verification of instruments for calibration status

9.5 Reference of Standard operating procedure (SOP)

9.6 Operational Requirements

9.7 Attachments

9.8 Deviations/Incident/Changes (if any)

9.9 Recommendations/Conclusion

9.10 Post approval

10.0 PERFORMANCE QUALIFICATION (PQ)

10.1 Objective

10.2 Reason for PQ

10.3 Training

10.4 Verification of instruments for calibration status

10.5 Performance Requirements

10.6 Attachments

10.7 Deviations/Incident/Changes/OOS (if any)

10.8 Recommendations/Conclusion

10.9 Post approval

Prepared by: Checked by:

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1.0 Pre-approval Protocol:

This document has been developed and the individuals listed below have reviewed the document
and agree with its content and with their signature grant approval for its execution).

Functional area Name Designation Signature Date

PREPARED BY

Validation QA

CHECKED BY

Quality Assurance

REVIEWED BY

Production Head

Warehouse Head

Environment, health
and safety

Quality Control Head

Engineering Head

APPROVED BY

QA Head

Plant Head

Prepared by: Checked by:

Sign. & Date: Sign. & Date:
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2.0 OBJECTIVE: To ensure that the critical attributes of the pharmaceutical manufacturing, packaging,
storage and Microbiological testing Facility/area are designed, installed and functioning as per the
designed specification throughout the anticipated operating ranges and meets the cGMP requirements
and regulations.

3.0 SCOPE: The scope of this Facility Qualification is that the Receipt, Storage, dispensing, sampling,
manufacturing, packaging, Microbiological testing and ancillary areas such as change rooms,
corridors etc. are constructed according to specified design/required standards and regulation.

4.0 REASON FOR QUALIFICATION:

The reason for preparing this document is:
Please tick any one (or multiple) option(s) from the following ():

New or refurbished area 

Major change in area/HVAC design 
Change in AHU/ AHU parameters 
Addition or removal of major equipment resulting in civil work 
Equipment replacement of different capacity 
Periodic Re-qualification 
Others (Specify) 

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5.0 RESPONSIBILITY: Personnel involved in qualification activity.

Department Name Activity

To prepare the document as per the

User Department user Requirement and Design of area
based on Process/Product, cGMP and
Regulatory guidelines.
To verify and document all the critical
aspects of Requirement and Design of
User Dept. Head
area based on Process/Product, cGMP
and Regulatory guidelines.

To verify the Engineering and safety

Engineering
aspects of the Area

Environment, Health To verify the Safety and Environment

and Safety aspects of the Area

To be a part of team and review the

Quality Assurance
documents

To review and approve the

QA Head requirement and Qualification
document

To review and approve the

Plant Head requirement and Qualification
document

Prepared by: Checked by:

Sign. & Date: Sign. & Date:
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6.0 USER REQUIREMENT SPECIFICATION (URS):

6.1 Objective: The objective of URS is to provide the requirement and appropriate design to identify
company needs and performance requirements of area including major ancillary component or
fabrication of the area so as to meet the in-house requirements as well as compliance with cGMP.
6.2 Reason for URS: To provide the requirements for Designing and installation of facility or area in
_____________ block for manufacturing, packaging, storage and Microbiological testing of
pharmaceutical products.
6.3 Requirements: All the requirements are mentioned area wise as per respective attachments as listed
in below table.
Refer Annexure No. Area Code Area Name
FQ/URS/B1/Annex-1
FQ/URS/B1/Annex-2
FQ/URS/B1/Annex-3
FQ/URS/B1/Annex-4
FQ/URS/B1/Annex-5
FQ/URS/B1/Annex-6
FQ/URS/B1/Annex-7

6.4 Attachments: This section contains a list of all additional attachments which are required to be
attached.

S.No. Attachment Details Refer Attachment No.

1. FQ/URS/B1/Attachment-1

2. FQ/URS/B1/Attachment-2

3. FQ/URS/B1/Attachment-3

6.5 Recommendations/Conclusion:
.....................................................................................................................................................................................
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Prepared by: Checked by:

Sign. & Date: Sign. & Date:
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Effective Date:

6.6 Post approval:

This document has been developed and the individuals listed below have reviewed the document
and agree with its content and with their signature grant approval for its execution).

Functional area Name Designation Signature Date

REVIEWED BY

Production Head

Warehouse Head

EHS

Engineering Head

Quality Control
Head

Quality Assurance

APPROVED BY

QA Head

Plant Head

Prepared by: Checked by:

Sign. & Date: Sign. & Date:
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7.0 DESIGN QUALIFICATION (DQ):

7.1 Objective: To prepare the detailed specification (Design data) of area to ensure that the user
requirement specification and Functional requirement specification or data sheet are achieved.
To design the area in conjunction with the design data in order to provide basis for the vendor,
manufacturer, contractor and design engineer for designing the area when the project begins.
7.2 Reason for DQ: To provide a design for installation of facility or area in _____________ block for
production of pharmaceutical products.
7.3 Requirements: All the requirements are mentioned area wise as per respective attachments as
listed in below table.
Refer Annexure No. Area Code Area Name
FQ/DQ/B1/Annex-1
FQ/DQ/B1/Annex-2
FQ/DQ/B1/Annex-3
FQ/DQ/B1/Annex-4
FQ/DQ/B1/Annex-5
FQ/DQ/B1/Annex-6
FQ/DQ/B1/Annex-7

7.4 Attachments: This section contains a list of all additional attachments which are required to be
attached.

S.No. Attachment Details Refer Attachment No.

1. FQ/DQ/B1/Attachment-1

2. FQ/DQ/B1/Attachment-2

3. FQ/DQ/B1/Attachment-3

7.5 Expected Documents and Drawings: A suggestive list (but not limited to), is as listed below:

Required
S.No. Document details
( /  )

1. Design Specifications 

2. Functional Specifications 

3. As Built Area Layout 

4. Instrument Listing 

Prepared by: Checked by:

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Required
S.No. Document details
( /  )

1. Utility supply Piping and Instrumentation Diagram (P&ID) 

2. MOC certificates 

3. Test certificates of components/ instruments 

4. Weld certificates (if any) 

5. Electrical drawings 

6. Other (Specify) 

: Applicable & required  : Not applicable

7.6 Recommendations/Conclusion:
.....................................................................................................................................................................................
.....................................................................................................................................................................................
.....................................................................................................................................................................................
........................................................................................................................................................ ...........................

7.7 Post approval:

This document has been developed and the individuals listed below have reviewed the document
and agree with its content and with their signature grant approval for its execution).

Functional area Name Designation Signature Date

REVIEWED BY

Production Head

Warehouse Head

EHS
Engineering Head
Quality Control
Head
Quality Assurance
APPROVED BY
QA Head
Plant Head

Prepared by: Checked by:

Sign. & Date: Sign. & Date:
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8.0 INSTALLATION QUALIFICATION (IQ):

8.1 Objective: To ensure that all the critical attributes of area have been taken care and to establish that
the area is constructed as per the approved design specification.

8.2 Reason for IQ: To verify the installation parameters of facility based on approved Design of
facility or area in _____________ block for production of pharmaceutical formulation.

8.3 Requirements: All the requirements are mentioned area wise as per respective attachments as
listed in below table.
Refer Annexure No. Area Code Area Name
FQ/IQ/B1/Annex-1
FQ/IQ/B1/Annex-2
FQ/IQ/B1/Annex-3
FQ/IQ/B1/Annex-4
FQ/IQ/B1/Annex-5
FQ/IQ/B1/Annex-6
FQ/IQ/B1/Annex-7

8.4 Attachments: This section contains a list of all additional attachments which are required to be
attached.

S.No. Attachment Details Refer Attachment No.

1. FQ/IQ/B1/Attachment-1

2. FQ/IQ/B1/Attachment-2

3. FQ/IQ/B1/Attachment-3

8.5 Expected Documents and Drawings: A suggestive list (but not limited to), is as listed below:

Required
S.No. Document details
( /  )

1. Design Specifications 

2. Functional Specifications 

3. As Built Area Layout 

4. Instrument Listing 

5. Utility supply Piping and Instrumentation Diagram (P&ID) 

Prepared by: Checked by:

Sign. & Date: Sign. & Date:
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Required
S.No. Document details
( /  )

6. MOC certificates 

7. Test certificates of components/ instruments 

8. Weld certificates (if any) 

9. Electrical drawings 

10. Other (Specify) 

: Applicable & required  : Not applicable

8.6 Deviations/Changes (if any):

………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
…………………………………………………………………………………………………………………..…..

8.7 Recommendations/Conclusion:
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………

Prepared by: Checked by:

Sign. & Date: Sign. & Date:
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Effective Date:

8.8 Post approval:

This document has been developed and the individuals listed below have reviewed the document
and agree with its content and with their signature grant approval for its execution).

Functional area Name Designation Signature Date

REVIEWED BY

Production Head

Warehouse Head

EHS

Engineering Head

Quality Control
Head
Quality Assurance
APPROVED BY

QA Head

Plant Head

Prepared by: Checked by:

Sign. & Date: Sign. & Date:
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Effective Date:

9.0 OPERATION QUALIFICATION (OQ):

9.1 Objective: To ensure that the critical attributes of the area are functioning as per the operational
specification throughout the anticipated operating ranges.

9.2 Reason for OQ: To verify the operating parameters of facility based on the approved Design of facility
or area in _____________ block for production of pharmaceutical formulation.

9.3 Training: Personnel involved in qualification activity.

Training Training report Checked by/

S.No. Name
status availability date

9.4 Verification of instruments for calibration status:

Checked
Calibration Calibration
S.No. Instrument Name Instrument ID by Sign/
done on due on
Date

Prepared by: Checked by:

Sign. & Date: Sign. & Date:
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9.5 Reference of Standard operating procedure (SOP):

Checked by
S.No. SOP Name SOP No.
Sign/ Date

9.6 Operational Requirements: All the requirements are mentioned area wise as per respective attachments
as listed in below table.
Refer Annexure No. Area Code Area Name
FQ/OQ/B1/Annex-1
FQ/OQ/B1/Annex-2
FQ/OQ/B1/Annex-3
FQ/OQ/B1/Annex-4
FQ/OQ/B1/Annex-5
FQ/OQ/B1/Annex-6
FQ/OQ/B1/Annex-7

9.7 Attachments: This section contains a list of all additional attachments which are required to be attached.

S.No. Attachment Details Refer Attachment No.

1. FQ/OQ/B1/Attachment-1

2. FQ/OQ/B1/Attachment-2

3. FQ/OQ/B1/Attachment-3

Prepared by: Checked by:

Sign. & Date: Sign. & Date:
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9.8 Deviations/ Incident/ Changes (if any):

.....................................................................................................................................................................................
.....................................................................................................................................................................................
.....................................................................................................................................................................................
.....................................................................................................................................................................................

9.9 Recommendations/ Conclusion:

.....................................................................................................................................................................................
.....................................................................................................................................................................................
.....................................................................................................................................................................................
.....................................................................................................................................................................................

9.10 Post approval:

This document has been developed and the individuals listed below have reviewed the document and
agree with its content and with their signature grant approval for its execution).

Functional area Name Designation Signature Date

REVIEWED BY
Production Head
Warehouse Head
EHS
Engineering Head
Quality Control Head
Quality Assurance
APPROVED BY
QA Head
Plant Head

Prepared by: Checked by:

Sign. & Date: Sign. & Date:
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Effective Date:

10.0 PERFORMANCE QUALIFICATION (PQ):

10.1 Objective: To confirm that the area/facility consistently meets the predetermined standards under normal
and worst conditions.

10.2 Reason for PQ: To verify the performance of facility based on the approved Design, process, product
and regulatory requirements of facility or area in _____________ block for production of
pharmaceutical formulation.

10.3 Training: Personnel involved in qualification activity.

Training Training report Checked by/
S.No. Name
status availability date

10.4 Verification of instruments for calibration status:

S.No. Instrument Name Instrument ID Calibration Calibration Checked

done on due on by Sign/
Date

10.5 Performance Requirements: All the requirements are mentioned area wise as per respective
attachments as listed in below table.

Refer Annexure No. Area Code Area Name

FQ/PQ/B1/Annex-1
FQ/PQ/B1/Annex-2
FQ/PQ/B1/Annex-3
FQ/PQ/B1/Annex-4
FQ/PQ/B1/Annex-5
FQ/PQ/B1/Annex-6
FQ/PQ/B1/Annex-7

Prepared by: Checked by:

Sign. & Date: Sign. & Date:
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Effective Date:

10.6 Attachments: This section contains a list of all additional attachments which are required to be attached.

S.No. Attachment Details Refer Attachment No.

1. FQ/PQ/B1Attachment-1

2. FQ/PQ/B1Attachment-2

3. FQ/PQ/B1Attachment-3

4. FQ/PQ/B1Attachment-4

5. FQ/PQ/B1Attachment-5

6. FQ/PQ/B1Attachment-6

7. FQ/PQ/B1Attachment-7

8. FQ/PQ/B1Attachment-8

9. FQ/PQ/B1Attachment-9

10. FQ/PQ/B1Attachment-10

10.7 Deviations/ Incident/ Changes/ OOS (if any):

………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………

10.8 Recommendations/ Conclusion:

………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………

Prepared by: Checked by:

Sign. & Date: Sign. & Date:
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Effective Date:

10.9 Post approval:

This document has been developed and the individuals listed below have reviewed the document and
agree with its content and with their signature grant approval for its execution).

Functional area Name Designation Signature Date

REVIEWED BY

Production Head

Warehouse Head

EHS

Engineering Head

Quality Control
Head

Quality Assurance

APPROVED BY

QA Head

Plant Head

Prepared by: Checked by:

Sign. & Date: Sign. & Date: