Facility Qualification Protocol

Facility Qualification is a process in which it is evaluated and documented whether or not a suitable facility is used to produce the products. Facility Qualification covers inspecting the production areas to check if rooms are appropriately sized; walls are of proper construction and finish to facilitate easy cleaning; there is sufficient lighting; facilities for proper ventilation and utilities are available; and sufficient drainage is in place. The latest building plans are annotated to record discrepancies.

Facility Qualification can consist of the following information:

1. Construction Materials: Determination of construction materials installed in rooms for walls, ceilings, and flooring. Determination of surface cleanability and acceptability for use in areas rated for particulates. Doors and windows must be in correct construction and in correct location.
2. Lighting Levels: Evaluation of lighting levels in the workplace to make sure it is sufficient for operations conducted.
3. Drainage: Sizing and inspection of floor drains for determining size and appropriate use of the drains in all processing areas. Inspect the system to ensure correct installation and compliance with design requirements.
4. Drain Air Breaks: System identification and inspection to ensure sufficient air breaks are present in an effort to abate back-siphonage.
5. Utilities: Documentation of identification and inspection of utilities (such as purified water, compressed gases and air, and clean steam) necessary for use by the process, and listed for each room to ensure correct installation and compliance to design requirements. Air supply and return grilles and diffusers are also documented.

Facility Qualification Protocol

TABLE OF CONTENT

Sr. No.	Title of Sections
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
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

1. 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

2. 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. 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. 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)

5. Responsibility

Personnel involved in qualification activity.

Department	Name	Activity
User Department		To prepare the document as per the user Requirement and Design of area based on Process/Product, cGMP and Regulatory guidelines.
User Dept. Head		To verify and document all the critical aspects of Requirement and Design of area based on Process/Product, cGMP and Regulatory guidelines.
Engineering		To verify the Engineering and safety aspects of the Area
Environment, Health and Safety		To verify the Safety and Environment aspects of the Area
Quality Assurance		To be a part of team and review the documents
QA Head		To review and approve the requirement and Qualification document
Plant Head		To review and approve the requirement and Qualification document

6. 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

6.4 Attachments:

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

Sr. 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:

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

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

ALSO READ: SOP for Process Validation and Equipment Qualification

7. 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

7.4 Attachments:

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

Sr. 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:

Sr. No.	Document details	Required
1.	Design Specifications
2.	Functional Specifications
3.	As Built Area Layout
4.	Instrument Listing

Sr. No.	Document details	Required
1.	Utility supply Piping and Instrumentation Diagram
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

8. 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

8.4 Attachments:

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

Sr. No.	Attachment Details	Refer Attachment No.
1.		FQ/IQ/B1/Attachment-1
2.		FQ/IQ/B1/Attachment-2
3.		FQ/IQ/B1/Attachment-3

ALSO READ: Garment Qualification, Handling, and Monitoring in Pharmaceutical Facilities

8.5 Expected Documents and Drawings:

A suggestive list (but not limited to), is as listed below:

Sr. No.	Document details	Required
1.	Design Specifications
2.	Functional Specifications
3.	As Built Area Layout
4.	Instrument Listing
5.	Utility supply Piping and Instrumentation Diagram
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 Recommendations/Conclusion:

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

8.7 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

9. Operational 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.

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

9.4 Verification of instruments for calibration status:

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

9.5 Reference of Standard operating procedure (SOP):

Sr. No.	SOP Name	SOP No.	Checked by 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

9.7 Attachments: 

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

Sr. No.	Attachment Details	Refer Attachment No.
1.		FQ/OQ/B1/Attachment-1
2.		FQ/OQ/B1/Attachment-2
3.		FQ/OQ/B1/Attachment-3

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

10. 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.

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

10.4 Verification of instruments for calibration status:

Sr. No.	Instrument Name	Instrument ID	Calibration done on	Calibration due on	Checked 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

10.6 Attachments:

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

Sr. 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

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

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

10.8 Recommendations/ Conclusion:

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

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

ALSO READ: Area Qualification Protocol