Equipment Qualification Principles And Practices
Equipment qualification is an important process for any equipment or instrument used in the pharmaceutical industry. First, need to understand what is a need for equipment qualification.
What is a need for Equipment qualification?
- It is a Regulatory requirement
- Proof for suitability for intended use
- To manufactured a quality product
- It is cost-effective
What are the steps involved in equipment qualification?
To know the basics of equipment qualification, important to know what are the steps involved in qualification?
- User Requirement Specification is well known as “URS”
- Design Qualification (DQ)
- Factory Acceptance Test (FAT) at the vendor site.
- Site Acceptance Test (SAT) at the user site.
- Installation Qualification (IQ)
- Operation Qualification (OQ)
- Performance Qualification (PQ)
Let’s understand the steps of qualification.
User Requirement Qualification (URS):
Design and Functional Specifications are part of user requirements specifications. In a design specification, the details of how the equipment must be designed, e.g. Specifically, Design Specifications provide knowledge of dimensions, construction materials, layouts, etc. of equipment, so they can be used to specify their design.
Design Qualification (DQ):
Specifications that specify the design and functionality of equipment, verified with the actual equipment details provided by our suppliers such as design and functionality. The Design Qualification is an activity that is part of the documentation and recommended to be completed before placing the purchase order.
Factory Acceptance Test (FAT):
FAT has some important checkpoints that shall be verify while this FAT test. FAT shall be conducted at the vendor manufacturing site.
- Tests the completeness of the installation.
- Verification of URS against the actual.
- Using conventional function testing or simulation, the functionality of the product is determined.
- Document quality (availability) verification.
- An overall review/inspection.
During the Factory Acceptance Test, the following should be accomplished:
- Make sure the equipment/instrument/system is functioning
- The equipment/instrument/system must function properly, have high quality, and be of high integrity.
- Confidence that the equipment/instrument/system will perform effectively under the full range of possible circumstances.
- Prior to shipping, make sure all failures out of the box have been eliminated.
- Ensure that faulty components can be modified, adjusted, and replaced without having to rely on fabrication shops.
Site Acceptance Test (SAT):
SAT is conducted to ensure that the instrument or equipment’s physical condition and availability of all components. The SAT includes:
- Verification of the design of the equipment
- Specifications of the equipment received from the Manufacturer / Vendor at the site of the User
- Physical Verification of consignment
Installation Qualification (IQ):
The installation qualification test includes checking:
- Compliance with all specifications described in the Design Qualification and/or manufacturer’s specification.
- Component damages.
- A review of all design features, such as dimensions, make, model, materials, etc., in relation to the Design Qualification specification and/or the manufacturer’s claim.
- List of Instruments that require qualification
- Utility connection in accordance with applicable specifications.
- Access to required documents, e.g. instruction manual, drawings, etc.
- Drawings verification
- A component is assembled against the recommendation of the manufacturer.
Installation Qualification should be requalified if:
- A change in the location of the equipment (excluding portable type).
- When major modifications are made or in the event that a new component is added, a qualification must be addressed
All results from the IQ will be summarized and compiled using a pre-approved protocol.
Operation Qualification (OQ):
- Specific functions of the system are tested by OQ, such as unit operational functions, specific equipment functions,
- This will ensure that the system operates within the recommended operating ranges so that the intended tasks can be performed.
- Evaluation of system performance is provided through the OQ execution process.
- Calibration and testing of the instruments are part of OQ.
- Instruments with potential for malfunction due to improper installation/transport calibrated at the site, such as dial-type gauges, load cells, etc.
- There is a provision in the IQ protocols to identify such instruments, which require calibration.
- In addition to confirming that the system is capable of performing its operational steps, OQ confirms that key parameters, functions, or parameters are being checked to ensure they comply with operating specifications. In order to begin the OQ execution, the results of the IQ execution must first be reviewed and approved.
- A site representative examines the calibration reports of any externally undertaken calibration activities to ensure compliance with the specifications laid down during OQ.
- This data came from a calibration report and qualification report submitted by an external agency.
- Change(s) made to the system/equipment during OQ that are reported in the OQ report. A change in OQ (on a PQ or during routine manufacturing) is managed in accordance with change control SOP.
- The Standard Operating Procedure for operating & maintaining the equipment, instruments & system (where applicable). It is prepared before/during the Operational Qualification process.
- Standard Operating Procedures must be approved and in effect before performance qualification begins.
Re-qualification is required in the event of:
- Moving the equipment from one location to another (except portable types).
- If a major modification is made or a newly added component needs to be qualified, RQ should be initiated (RQ is described separately).
Performance Qualification (PQ):
To determine whether or not pharmaceutical grade products, equipment, environments, or support systems meet required output, the PQ takes into account procedures, personnel, systems, and materials. Outputs are either products or products in contact with products (e.g., compressed air, purified water) or the environment (e.g., HVAC system).
During the design of testing protocols, the following principles are followed, and explanations are provided,
- System functions have a number of variables associated with them as well as relationships between systems, processes (unit operations), and formulations and products. Based on the basis for PQ verification steps, the relationship can be strong to weak.
- Testing of specific equipment variables during PQ as defined in the protocol, as well as load trials.
- As part of a process validation exercise, process measures are examined that are dependent on formulation characteristics and the interaction between the processes and the formulae. In Qualification of the Blender, achieving Blend Uniformity (BU) is more a matter of the type of formulation variables and relationships with the processes involved.
- Further, edge failure cases were also considered in the capacity and occupancy calculations.
- When cleaning procedures are not adequate, any equipment in direct contact with a product (process steps and primary packing) can adversely affect the product. Hence, during process qualification, the fundamental elements of baseline data are established, such as the Total Contact surface area. In addition, equipment was cleaned as per SOP, and visual checks were conducted for cleanliness. As a result, protection provides a “Procedures to obtain baseline data, to assure the cleaning validation program matrix is valid during PQ.
The following pre-requisites must be met before PQs can be executed:
- Reports of approved OQs are available
- Availability of effective operating procedures for equipment calibration, cleaning, and maintenance
- Personnel training
- Calibrating and scheduling PMs
- PLC validation is complete
- In case the vendor is executing the GDP protocol, training is provided to the vendor
There should be a clear indication of acceptance criteria in the PQ document.
As the last of the qualification steps, PQ is an evaluation of how equipment/system will perform in simulated or actual production and operational conditions. In this series of tests, we demonstrate that the system/equipment can produce product with specified quality and functionality even in the most extreme cases.
Re-qualification of Performance Qualification is required if:
- A new instrument is added to the equipment to replace an existing instrument, which may have an adverse effect on its performance.
- Equipment/System modifications that significantly affect the equipment’s performance.
- When the performance qualification is performed, the system is found to be malfunctioning.
PQ executed according to a pre-approved protocol
IQ, OQ, and PQ are all part of re-qualification and include complete or portions of ‘elements’ of qualification.
A requalification may be conducted for one or more of the following reasons:
- Identify and correct deficiencies observed during a qualification
- Criteria for qualification tests need to be added
- Qualification of changes to equipment or a process involving equipment
- Inspection/Audit/PQR findings/recommendations.
- Results of the Preventive Maintenance/Calibration Program
- Upgrade of Equipment
While re-qualifying equipment, not only are changes and deficient parameters verified, but all critical equipment components are also tested for functionality.
This is a brief about equipment qualification principles and practices in pharmaceuticals.
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