Area Qualification Protocol in Pharmaceuticals

The Area Qualification Protocol plays an important role in the pharmaceutical sector, serving as a vital process that ensures compliance and upholds quality standards across various sections within a pharmaceutical facility. This protocol entails a thorough assessment and examination of the important zone including cleanrooms, manufacturing areas, storage spaces, and laboratories to validate their appropriateness for specific pharmaceutical operations. Its comprehensive nature guarantees the suitability and reliability of these areas, contributing significantly to maintaining industry standards and regulatory requirements.

Area Qualification Protocol Content:

Serial No.	Item Description
1.0	Protocol Approval
2.0	Overview:
2.1	Objective
2.2	Purpose
2.3	Scope
2.4	Responsibility
2.5	Execution Team
3.0	Acceptance criteria
3.1	Construction features/layout
3.2	Re-qualification criteria
4.0	Area Qualification Procedure
4.1	Instruction for Filling the Checklist
5.0	Verification of Physical Parameters
5.1	Equipment Details.
5.2	Observation of Area.
6. 0	Deficiencies and Corrective Action Report
7.0	Area Qualifications Final Reports
7.1	Summary
7.2	Conclusion
7.3	Final report approval

1.0 Protocol Approval:

This qualification protocol for the area has been reviewed and approved by the following persons:

FUNCTION	NAME	DEPARTMENT	SIGNATURE	DATE
Prepared By		Quality Assurance
Reviewed By		Projects / Engineering
Reviewed By		Production
Reviewed By		Quality Control
Approved By		Quality Assurance

2.0 Overview:
2.1 Objective:
The objective of developing and executing this protocol is to collect sufficient data pertaining to the area and define the qualification requirements as per the acceptance criteria in static conditions.

2.2 Purpose:
The purpose of this protocol is to establish documentary evidence to ensure that the area is controlled as per the requirement suitable for manufacturing.
2.3 Scope:
This protocol is applicable for the Qualification of PPM Staging area in the manufacturing facility.

2.4 Responsibility:
The following shall be responsible;
Projects / Engineering – For execution.
Production Head – For execution support.
Quality control head – For area monitoring and for execution.
Quality Assurance Head – For adequacy and final approval.

2.5 Execution Team:
The qualification of the area shall be verified by executing the qualification studies and test procedures as described in this protocol. The successfully executed protocol documents that the area is qualified as per the design. All executors involved with this protocol shall sign within the prescribed format given below.

DEPARTMENT	DESIGNATION	NAME	SIGNATURE	DATE
Projects
Production
Quality Control
Quality Assurance

3.0 Acceptance Criteria:
3.1 Construction Features/layout:
3.1.1 All criteria mentioned in the verification of physical parameters should be met.
3.2 Requalification criteria:
The area has to be qualified if-

• There are any major civil changes that affect the performance of the area
• After any changes in HVAC system components
• There are any changes in the operational layouts.
• There are any major changes in the utility point.

4.0 Area Qualification Procedure:
4.1 Instruction for Filling the Checklist
4.1.1 In case of compliance with the test use the word ‘Complies’ otherwise use’ Does not comply ‘ to indicate non-compliance.
4.1.2 For Verification of physical parameters use the word ’Complies’ if the parameter matches with the Design specification and use ‘Does not comply’ if the parameter is not matching with the specification.
4.1.3 Give detailed information in the summary and conclusion part of the
Area Qualification Report.
4.1.4 Whichever column is blank or not used ‘NA’ shall be used.

5.0 Verification of Physical Parameters for Packing Hall.

Electrical:

Wiring	Concealed type.	As Build	Checked By/Date
Electrical fittings	Enclosed in SS Box and of industrial type.
No. Of Lighting fixtures	09.
Flameproof fittings	NA.
Luminance (Lux)	NLT 400 Lux.

Related: Risk Assessment Protocol

Service/Utilities:

Purified water	NA.	As Build	Checked By/Date
Compressed air	NA.
Identification of different utilities	NA.

Air handling system:

AHU no.		AHU- AHF-1B.		As Build		Checked By/Date
No. of  supply air grills		03.
No. of return riser grills		04.
Dimension of supply air grill		2×2 sq ft.
Dimension of return air riser/grills.
Position of filter	Terminal.
Air Flow	736 CFM.
No. of air changes per hour	20
Temperature range	25 ± 2° C
Relative Humidity range	50 ± 5%
Pressure differential with respect to adjacent area	Pressure differential with respect to the adjacent area

Related: Protocol on Hold Time Study of Machine Parts

GMP Requirements:

Flow of Personal	Interlocking System	As Build	Checked By/Date
Gowning facility	Required for operation and cleaning in the specified area.
Area	Adequate space in the area is provided for the storage of materials.
Noise level of the room	NMT 65 db.
Status Board	NA.
Room numbering and identification	Room is having proper identification and number i.e. RF-15.
SOP stands	Provided.
Status board	Provided

5.1 Equipment Details:

Sr. No	Equipment Name	Equipment Id.	Utility Requirements.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.

6.0 Deficiencies and Corrective Action Report

The following deficiencies were verified and corrective actions were taken in consultation with the Engineering Department.

Description of deficiency

Corrective action(s) taken :

Comments:

Reviewed By:
Date

7.0 Area Qualifications Final Reports:

All the data sheets and discrepancy reports shall be reviewed by the execution team to prepare a summary report. The summary of the qualification report shall be used to draw a conclusion for approval of the area qualification report.

7.1	Summary :
7.2	Conclusion :

7.3 Final report approval

It has been verified that all tests required by this protocol are completed, reconciled, and attached to this protocol or included in the qualification summary report. Verified that all amendments and discrepancies are documented, approved, and attached to this protocol.

The signature in the block below indicates that all items in this qualification report of the area have been reviewed and found to be acceptable and that all variations or discrepancies have been satisfactorily resolved.

NAME	DESIGNATION	DEPARTMENT	SIGNATURE	DATE
		Project/ Engineering
		Production
		Quality Assurance