SOP for Facility Design, Facility, Equipment and System Qualification

OBJECTIVE

To describe the procedure for facility design, facility, equipment, and system Qualification.

SCOPE

• This SOP applies to pharmaceutical Facilities.

1. When designing the new facility.
2. Revamping of the existing facility.

• This SOP is applicable for the qualification of all equipment, instruments, facilities, and utilities at pharmaceutical manufacturing plants.

RESPONSIBILITY

The user department shall be responsible for-

• Preparation of the User Requirement Specification (URS) w.r.t. Equipment, Instruments, Facility and Utility.
• Preparation of design qualification (if required).
• Qualification protocols preparation.
• The user shall notify to Plant Head for Qualification of each & every Equipment, Instrument, Facility, and Utility.

The engineering department shall be responsible for –

• Providing technical assistance to the user department for the preparation of required documents.
• Installation of machines, and utility at the designated place.

QA department shall be responsible for –

• Review protocols and provide technical inputs.
• Review qualification reports for their completeness and correctness w.r.t. all data and reports.
• Preparation of Qualification master plan.

All Department Head

• Shall review and sign all protocols, reports, and Qualification master plan.
• The site Quality Head shall approve protocols and reports and the Qualification masterplan.
• External Agency shall provide technical assistance for the preparation of documents and execution of activities whenever required.

DEFINITION

Equipment Qualification Master Plan (EQMP):

• A summary document prepared as part of project planning that describes overall philosophies, approaches, and objectives to all aspects of the qualification.
• The document defines responsibilities and expectations for the various steps of the qualification exercise and also establishes timelines for the completion of each component.

Instrument Qualification Master Plan (IQMP):

• Prepare a summary document as part of planning that describes overall philosophies, approaches, and objectives to all aspects of the qualification.
• The document defines responsibilities and expectations for the various steps of the qualification exercise and also establishes timelines for the completion of each step.

Critical equipment:

• Critical equipment is the equipment needed for processing, packaging, holding, or supporting products that have the potential to directly impact critical process parameters and the quality of the product.

Non-critical equipment:

• Non-critical equipment is the equipment needed for processing, packaging, holding, or supports of products that do not have the potential to directly impact critical process parameters and the quality of the product.

User Requirement Specification (URS):

• The documented requirement of the equipment, the utility for its intended purpose. Functional design specification (FDS) according to cGMP and regulatory requirements.

Design Qualification (DQ):

• Documented verification to ensure that the proposed design of the equipment, and utility is suitable for the intended purpose at it meets in all aspects.

Installation Qualification (IQ):

• Documented verification that the equipment, utility as installed or modified, comply with the approved design, manufacturer’s recommendations, and user requirements FAT & SAT to be added.

Operational Qualification (OQ):

• Documented verification that all the components of a system or of a piece of equipment operate as specified. This involves testing of all normal operating controls; all alarm points, all switches, and displays, interacting controls, and any other indications of operations and functions.

Performance Qualification (PQ):

• Documented verification that the equipment, and utility are performing effectively and reproducibly, based on approved methods and specifications.

ALSO READ: Factory Acceptance Testing and Site Acceptance Testing

Factory Acceptance Test (FAT):

• Documented verification to ensure of the compliance of the equipment at the vendor's site against the approved design.

Site Acceptance Test (SAT):

• Documented verification to ensure of the compliance of the equipment at the user site against approved design as well as against FAT.

Re-qualification:

• Reconfirming that the area, equipment, instrument, utility, the system is meeting the predefined acceptance criteria after major changes in the parameters or after a definite period, if there is no major change.

PROCEDURE

All the new facilities and equipment shall be qualified prior to use in production as per the procedure given below

Design Qualification (DQ)

• The first task of qualification for the new facility, system, and equipment shall start with Design Qualification.
• The Design Qualification protocol shall be prepared by the concerned department with the incorporation of a supplier or vendor in accordance with user requirements.
• For DQ first make the necessary diagrams layouts and write down the tentative specification with the help of the supplier’s specification and user requirements by considering regulatory cGMP requirements and safety requirements.
• The Design Qualification protocol shall be prepared for each equipment/system/facility based on quotation/proposal and technical discussions between the supplier and user department.
• Design Qualification shall be done based on the process requirements, cGMP Requirements like the material construction of product contact parts, etc.., and safety parameters like earthing parameters, overload settings, etc.
• Approvals of concerned persons mentioned in the protocol shall be taken and then execute the protocol.
• The compliance of the design with cGMP and also with the specification should be demonstrated and documented as per the general guideline mentioned in the Master Qualification/Validation Protocol.
• Once design qualification is over, a Purchase order will be released to the vendor along with the specifications.

Installation Qualification (IQ)

• Installation Qualification (IQ) shall be performed on new or modified facilities, systems, and equipment.
• IQ shall contain, but not be limited to the following points

1. Installation of equipment, piping, services, and instrumentation shall check to current engineering drawings and specifications.
2. Collection of supplier operating and working instructions and maintenance requirements.
3. Calibration requirements.
4. Verification of construction and design criteria as applicable at this stage.

• The installation qualification shall certify and demonstrate the cGMP requirement and be documented, as per the guidelines mentioned in the Master Qualification/Validation Protocol.

Operational Qualification (OQ)

• Operational Qualification (OQ) shall be performed after completion of Installation Qualification.
• OQ shall contain, but not be limited to the following points.

1. Tests that have been developed from knowledge of processes, systems and equipment and working of the subsystem.
2. Tests to include conditions encompassing upper and lower limits of operation.
3. Verification of operation criteria and specifications.
4. Development of operating and cleaning SOPs, maintenance schedule, and Training of operators.

• The successful operational qualification shall be well demonstrated and documented, as per the guidelines mentioned in the Master Qualification / Validation Protocol.

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Performance Qualification (PQ)

• Performance Qualification shall follow after the successful completion of Installation Qualification, Operational Qualification and after getting the clearance for Performance Qualification by Validation Team.
• PQ shall include, but not be limited to the following;

1. Tests, using production materials, qualified substitutes or simulated products that have been developed from knowledge of the process and the facilities, systems or equipment.
2. Tests to include a condition or set of conditions encompassing upper and lower operating limits.

• After successful Operational Qualification Quality Assurance Department shall prepare the Performance Qualification Protocol and perform the qualification of facilities and equipment as per the approved protocol.
• The final release of facility/equipment will be given by Head - Quality Assurance/Site Quality Head for the usage of equipment after review of the Performance Qualification Report.

Re-Qualification

• Re-qualification of all critical equipment like Autoclave / Tunnel / Capsule Filling machine etc. shall be done at definite intervals as per Validation Master Plan, under defined criteria.
• The Criteria for re-qualification is given below;

1. Any major modification in the facility or design of equipment/system.
2. Change in the site of equipment
3. Periodic re-qualification of any equipment or system shall be done as mentioned in the individual qualification protocol.

• The scope of re-qualification shall be decided by the validation team, depending upon the reason for re-qualification.

Facility Design

• Design development of the facility shall be carried out before the construction of the new facility or revamping of the existing facility and the approach consists of the following steps.

1. Facility URS
2. Conceptual study
3. Preparation and Approval of drawings and specifications
4. Construction
5. Facility qualification

• Facility URS is the initial document prepared during the initial stage of the Project.
• The conceptual document is prepared based on the Facility URS, which contains the design philosophy required to proceed to the next phase of development.
• Following are the general GMP requirements but not limited to, which shall be built into the facility during designing

1. The flow of materials & personnel through the building or facilities should be designed to prevent mix-ups or contamination.
2. Adequate ventilation, air filtration, and exhaust systems should be provided, where appropriate.
3. A proper drainage system should be provided.
4. There should be an adequate arrangement for the disposal of wastewater and other residues from the laboratory and production areas.
5. Quality control and other refreshment areas shall be independent of the production area.
6. Working and in-process space shall be adequate to permit orderly and logical positioning of equipment.
7. Pipework, electrical fittings, ventilation openings, and similar service lines shall be designed, fixed, and constructed to avoid the creation of recesses.
8. Service lines shall preferably be identified by colors and the nature of the supply and the direction of the supply and the direction of the flow shall be marked/indicated.

ALSO READ: Checklist for Supplier Qualification

• In the sterile facility,

1. The manufacturing areas shall be clearly separated into support areas (eg: washing & component preparation areas, storage areas etc.), preparation areas (eg: bulk manufacturing area, non-aseptic blending areas, etc), change areas, and aseptic areas.
2. Light fittings and air grills shall be flushed with walls and not hanging from the ceiling, to prevent contamination.
3. There shall not be any sinks and drains in the Grade A & Grade B areas.
4. Doors shall be made of non-shedding materials, preferably of Aluminium or steel material. Wooden doors shall not be used.
5. Doors shall open towards the high-pressure area so that they close automatically due to air pressure.
6. Materials transfer between aseptic areas and outside through suitable airlocks or pass boxes.
7. Change rooms should be given an appropriate interlocking system, to prevent the opening of more than one door at a time.
8. The interior surfaces (walls, floor, ceiling) shall be smooth and free from cracks, and coved, permitting easy cleaning, painting, and disinfection.
9. Facilities should be designed, constructed, and maintained to prevent the entry of insects, pests, birds, vermins, and rodents.
10. Adequate lighting should be provided in all areas to facilitate proper operations.

• Drawings should be prepared as per the format.
• Drawings can be taken printout in A4 or in A3 size paper depending on the requirement.
• The drawing format consists of the following

1. The direction symbol will be at the top left corner if required, which shows all four directions East, West, North, and South.
2. The entire drawing shall have a Single line border and be drawn to scale.
3. The legend should be there in all the drawings.
4. At the bottom right corner, the footer is present.

Footer format

1. In the first row of the footer write the Company logo & Name with an address.
2. Write the Block name, Floor number, and Type of the drawing against the TITLE.
3. Write the No. of the drawing against DRAWING No.
4. Write the size of the scale against the SCALE.
5. Write the sheet number X of Y (X is the sheet number and Y is the total number of sheets) against SHEET.
6. Write the version number against REVISION.
7. Write the names of the persons against DRAWN BY, REVIEWED BY, and APPROVED BY.
8. Write the note points against the NOTE.

• Any change in the facility should be through change control.

Procedure for signing the drawings

1. A person who draws the drawings shall sign against DRAWN BY followed by a date.
2. A person, who signs against REVIEWED BY, should review the drawings with for their adequacy.
3. Head Projects and Head QA will sign against APPROVED BY.
4. Project department approval ensures that the drawing meets the process requirements.
5. QA approval ensures that the drawing meets the Regulatory and cGMP requirements.

• Based on the drawings and the defined criteria, Room Data Sheets are developed.
• For each room, the Room Data Sheet Should be prepared as per the Unique Format No.
• The contents of the Room Data Sheets may vary from room to room and those should be maintained in electronic format.
• The projects & QA departments shall approve the Room Data Sheets.
• The construction work starts after the approval of the Drawings & the Room Data Sheets developed.

Construction

1. Careful supervision should be done during the construction phase to make sure that all the design specifications are being met.
2. After the construction of the new facility or revamping, it should be qualified through the Facility Qualification Protocol.

Facility Qualification

1. Facility qualification should be carried out block-wise and also by Room-wise.
2. A facility Qualification Protocol should be prepared block-wise to qualify the facility.
3. The Facility qualification protocol shall be as detailed as possible to avoid later confusion.
4. Facility qualification Protocol should be prepared as per the format.

ABBREVIATIONS

SOP - Standard Operating Procedure

DQ - Design Qualification

IQ - Installation Qualification

OQ - Operation Qualification

PQ - Performance Qualification

cGMP - Current Good Manufacturing Practice

REVISION HISTORY

Nil

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