The qualification of equipment in pharmaceutical manufacturing is not simply a compliance requirement. But it is part of the scientific process utilized to ensure that the equipment, utilities or systems will continue to perform as expected. The qualification process consists of several phases.
The first phase of qualification is called installation qualification (IQ). This phase represents the interface between theory and reality. In this phase, the manufacturer verifies that equipment, utilities or systems are installed according to design specifications that have been approved.
This article provides insight about installation qualification in pharmaceuticals including information regarding purpose, process, documentation and good manufacturing practice (GMP) requirements.
- That the system was installed according to design and purchasing specifications.
- All the system's components and instruments are present and have been identified properly.
- Installation has been completed using the approved installation drawings and layouts.
- There is sufficient utility supply like electrical, pneumatic, hydraulic etc. connected to the installed equipment.
- Safety labels and safety interlocks are in place.
- Calibration and certification documentation for all critical instruments are available.
- Documentation for operations, maintenance and cleaning is available for the installed equipment.
IQ is about verifying that the system has been built and is therefore capable of maintaining a state of compliance with current GMP regulations throughout its expected lifecycle.
1. Installation of New Equipment - When a new machine or system is introduced to a production, QC, or utility environment.
2. Relocation of Equipment - Move equipment from one location to another as it would not be able to function properly.
3. Major Overhaul or Modification - Any major modifications performed to the components of the equipment will be followed by IQ.
4. Post-maintenance or upgraded - For critical equipment types where the quality or the validation status is affected.
The level of detail and extent of an installation qualification will vary based on the type of equipment being qualified and its importance in relation to its impact on the overall quality of the product produced.
US FDA – 21 CFR Part 211.63: "Equipment should have the appropriate design, size and location to meet the intended use."
EU GMP Annex 15 Section 3.2: "Installation Qualification should be conducted on all new or modified systems, equipment and facilities."
World Health Organization Technical Report Series No. 1019: "The IQ is to ensure the comparison of installation against design recommendations and manufacturer's recommendations."
Schedule M (India): All GMP critical installation qualification to have proper Installation and Qualification.
During regulatory audits, inspectors routinely ask manufacturers to provide installation qualification protocols, installation qualification reports and documentation of calibration or certification of IQ.
The typical contents of an IQ protocol are as follows:
1. Objective & Scope - The reason for performing the IQ and what it will cover.
2. Responsibilities - The departments involved in the IQ process (engineering, QA, QC, production).
3. Equipment Information - The equipment name, model, serial number, manufacturer name and location.
4. Reference Documentation - Drawings, vendor manuals and DQ reports to be used in the IQ.
5. Installation Checks - To confirm mechanical, electrical and instrumentation connections were made.
6. Equipment Identification - Equipment ID, calibration tag and nameplate for the equipment.
7. Utilities Verification - Electricity, air, vacuum, etc.
8. Documentation Review - Availability of operating instructions, certificates of reliability and technical specifications of the equipment.
9. Safety & Good Manufacturing Practices Compliance - Safety guards, earthing, restricted access, cleanability, etc.
10. Deviation & Change Control - Any deviations or changes during the execution of the IQ.
11. Approval Signatures - Engineering, QA and user department.
Download Installation Qualification Sample Protocol
A. Physical Evaluation: Equipment should be verified to ensure that they are positioned where indicated in the approved layout. Also confirm that required clearances exist for maintenance and operation purposes.
B. Mechanical Evaluation: Examine the integrity of bolts, joints, piping, valves, filters and gaskets. Also confirm that all equipment components are correctly aligned and properly levelled.
C. Electrical and Control Assessment: Conduct an inspection of the equipment for correctness regarding wiring, grounding, fuses, emergency stops, etc. Verify to confirm that equipment is connected properly for power source and control panel.
D. Utility Assessment: Confirm that air, vacuum, water and nitrogen source lines have been connected correctly, labelled appropriately and that pressure and flow rates for air, water and nitrogen sources meet the specifications identified in the design.
E. Review of Documentation: Confirm that equipment manufacturer’s manuals, calibration certificates, FAT and SAT reports and all other vendor documentation have been reviewed, accepted and approved.
F. Safety Features: Conduct inspection to confirm that the equipment has installed, working safety alarms, guards and emergency stop buttons.
G. Equipment Identification Tags: Confirm that the equipment has visible identification tags for calibration status and preventive maintenance records.
Once the above evaluations are completed then the report will summarize all observations, results and any deviations noted during the installation qualification.
The IQ Report contains:
- Equipment and system information
- Summary of verification results
- Calibration certificate copies
- Lists of all attached documentation and drawings
- Details of any deviation and corrective actions taken
- Signature approvals from QA, engineering and user departments.
The IQ report provides documentation that the equipment is properly installed and available for further use during the OQ phase.
All deviations need to be documented, investigated and resolved before IQ is completed. Possible corrective actions include remedial action, re-assessment of the system or a change to the design of the system.
To maintain the integrity of the qualification process, the quality assurance department must review and approve all deviations prior to final approval of IQ.
In these situations, it is essential that the equipment be re-qualified in order to ensure that it complies with the appropriate standards. Prior to making any changes, the organization should establish a change control process. This process should include an assessment of the affect of the proposed change, including whether the re-qualification will be a partial or full qualification.
The establishment of a robust change control process will not only help the organization maintain the long term reliability of the equipment, but will also help ensure compliance with good manufacturing practices (GMP).
- The primary purpose of installation qualification is to ensure that the equipment is installed properly.
- The objective of operational qualification is to ensure that the equipment performs within the specified limits.
- The performance qualification process is used to confirm that equipment continues to perform consistently when used on regular basis.
- Periodic review of validation status confirms that continuous validation status is maintained.
By including installation qualification as a key part of the validation lifecycle, companies can assure equipment quality and performance in a systematic manner.
1. Regulatory Compliance: An IQ conforms to the good manufacturing practices (GMPs) of the USFDA, Europe (EMA), World Health Organization (WHO) and Schedule M.
2. Reduction of Equipment Failures: An IQ ensures the appropriate installation and proper operation of the utilities used throughout the life of the equipment.
3. Improvement of Data Integrity: An IQ creates documentation that is traceable during an audit.
4. Assurance of Worker Safety: The safety interlocks and protective devices associated with the equipment have been checked and are functioning correctly.
5. Streamline the Validation Process: Completion of an IQ establishes a foundation on which the operation qualification (OQ) and performance qualification (PQ) can occur.
An IQ assures that the entire qualification process is valid, thus the downstream validation activities will be valid and conform to regulations.
The installation qualification is the very first stage of the qualification and validation process and is critical in ensuring that all pharmaceutical equipment or systems are properly installed, safely installed and meet all requirements of both the regulations and the design expectations.
The IQ provides evidence that the installation of the equipment or system meets the minimum requirements for the equipment or system to be operated and functioned correctly. When performed properly it will be the basis for an auditable, compliant and reliable manufacturing environment.
Combining IQ with the total validation lifecycle and the use of detailed records, pharmaceutical organizations can prove their commitment to quality, compliance and patient protection and it is the real definition of good manufacturing practice (GMP).
The first phase of qualification is called installation qualification (IQ). This phase represents the interface between theory and reality. In this phase, the manufacturer verifies that equipment, utilities or systems are installed according to design specifications that have been approved.
Understanding Installation Qualification (IQ)
Installation qualification (IQ) provides supporting documentation to prove that all essential elements of the approved design, manufacturers' recommendations and good manufacturing practice (GMP) are in accordance with all requirements.- The verification of the following will occur during IQ:
- The successful delivery and installation of all equipment
- All utilities and components installed according to specifications
- Calibration of all measurement and control systems
- Availability of all required documentation, certificates and manuals
The Purpose of Installation Qualification
The primary purpose is to ensure confidence that the installation of the equipment has been done correctly and completely so that it can be traced back to what was designed or purchased. IQ specifically verifies the following:- That the system was installed according to design and purchasing specifications.
- All the system's components and instruments are present and have been identified properly.
- Installation has been completed using the approved installation drawings and layouts.
- There is sufficient utility supply like electrical, pneumatic, hydraulic etc. connected to the installed equipment.
- Safety labels and safety interlocks are in place.
- Calibration and certification documentation for all critical instruments are available.
- Documentation for operations, maintenance and cleaning is available for the installed equipment.
IQ is about verifying that the system has been built and is therefore capable of maintaining a state of compliance with current GMP regulations throughout its expected lifecycle.
When is Installation Qualification Required?
Throughout the various stages of an equipment's lifecycle, installation qualification is performed on numerous occasions:1. Installation of New Equipment - When a new machine or system is introduced to a production, QC, or utility environment.
2. Relocation of Equipment - Move equipment from one location to another as it would not be able to function properly.
3. Major Overhaul or Modification - Any major modifications performed to the components of the equipment will be followed by IQ.
4. Post-maintenance or upgraded - For critical equipment types where the quality or the validation status is affected.
The level of detail and extent of an installation qualification will vary based on the type of equipment being qualified and its importance in relation to its impact on the overall quality of the product produced.
Regulatory Expectations for Installation Qualification
All worldwide regulatory authorities have established regulatory expectations that establish that the IQ should be adequately documented when establishing compliance with Good Manufacturing Practices (GMP) for all equipment, systems and facilities.US FDA – 21 CFR Part 211.63: "Equipment should have the appropriate design, size and location to meet the intended use."
EU GMP Annex 15 Section 3.2: "Installation Qualification should be conducted on all new or modified systems, equipment and facilities."
World Health Organization Technical Report Series No. 1019: "The IQ is to ensure the comparison of installation against design recommendations and manufacturer's recommendations."
Schedule M (India): All GMP critical installation qualification to have proper Installation and Qualification.
During regulatory audits, inspectors routinely ask manufacturers to provide installation qualification protocols, installation qualification reports and documentation of calibration or certification of IQ.
Pre-Requisites for Conducting IQ
The following items must be completed prior to beginning installation qualification (IQ).- A design qualification (DQ) must be finalized and reviewed.
- Procurement documentation like URS, quotes, vendor data sheets must exist.
- Verification of utility readiness like electricity, compressed air, water, HVAC.
- Upon receipt of equipment, verify that the equipment is in compliance with purchase order specifications.
- Have calibration and testing certification documents for all instruments & control systems.
- Have available SOPs for installing, cleaning, maintaining and operating.
Installation Qualification Protocol
An installation qualification (IQ) protocol is a document that provides an outline of all the necessary steps, checks, responsibilities and documents necessary to validate the installation of equipment. The IQ protocol must be reviewed and approved before the execution of an installation qualification by the quality assurance (QA) department.The typical contents of an IQ protocol are as follows:
1. Objective & Scope - The reason for performing the IQ and what it will cover.
2. Responsibilities - The departments involved in the IQ process (engineering, QA, QC, production).
3. Equipment Information - The equipment name, model, serial number, manufacturer name and location.
4. Reference Documentation - Drawings, vendor manuals and DQ reports to be used in the IQ.
5. Installation Checks - To confirm mechanical, electrical and instrumentation connections were made.
6. Equipment Identification - Equipment ID, calibration tag and nameplate for the equipment.
7. Utilities Verification - Electricity, air, vacuum, etc.
8. Documentation Review - Availability of operating instructions, certificates of reliability and technical specifications of the equipment.
9. Safety & Good Manufacturing Practices Compliance - Safety guards, earthing, restricted access, cleanability, etc.
10. Deviation & Change Control - Any deviations or changes during the execution of the IQ.
11. Approval Signatures - Engineering, QA and user department.
Download Installation Qualification Sample Protocol
Installation Qualification Execution
After the compliance of the protocol is completed, the physical and visual representation will then start. All observations will be documented into the protocol and associated data sheets.A. Physical Evaluation: Equipment should be verified to ensure that they are positioned where indicated in the approved layout. Also confirm that required clearances exist for maintenance and operation purposes.
B. Mechanical Evaluation: Examine the integrity of bolts, joints, piping, valves, filters and gaskets. Also confirm that all equipment components are correctly aligned and properly levelled.
C. Electrical and Control Assessment: Conduct an inspection of the equipment for correctness regarding wiring, grounding, fuses, emergency stops, etc. Verify to confirm that equipment is connected properly for power source and control panel.
D. Utility Assessment: Confirm that air, vacuum, water and nitrogen source lines have been connected correctly, labelled appropriately and that pressure and flow rates for air, water and nitrogen sources meet the specifications identified in the design.
E. Review of Documentation: Confirm that equipment manufacturer’s manuals, calibration certificates, FAT and SAT reports and all other vendor documentation have been reviewed, accepted and approved.
F. Safety Features: Conduct inspection to confirm that the equipment has installed, working safety alarms, guards and emergency stop buttons.
G. Equipment Identification Tags: Confirm that the equipment has visible identification tags for calibration status and preventive maintenance records.
Once the above evaluations are completed then the report will summarize all observations, results and any deviations noted during the installation qualification.
Installation Qualification Report
The IQ report is created after successful installation of equipment or systems and will be written and reviewed by all departments with an interest in the equipment or system.The IQ Report contains:
- Equipment and system information
- Summary of verification results
- Calibration certificate copies
- Lists of all attached documentation and drawings
- Details of any deviation and corrective actions taken
- Signature approvals from QA, engineering and user departments.
The IQ report provides documentation that the equipment is properly installed and available for further use during the OQ phase.
Common IQ Documents and Attachments
Below is a list of the common types of supporting documents that are included in a complete IQ package.- Approved DQ report
- User Requirement Specification (URS)
- Purchase Order & Vendor Documents
- Equipment and Utility Drawings (P&ID, Electrical, Layout etc.)
- Calibration and Test Certificates
- SOPs related to operation & cleaning
- Preventive Maintenance Schedule
- Instrument List with Tags
- FAT/SAT reports
- As-built Documents
Deviation Handling in Installation Qualification
When installing or qualifying a system, there may be deviations from the intended specifications, such as missing parts, wrong connections, wrong wiring or incomplete documentation.All deviations need to be documented, investigated and resolved before IQ is completed. Possible corrective actions include remedial action, re-assessment of the system or a change to the design of the system.
To maintain the integrity of the qualification process, the quality assurance department must review and approve all deviations prior to final approval of IQ.
Requalification and Change Control
The equipment is never going to stay the same for long. The qualifications you have today may no longer be valid due to relocations, replacing or modifying equipment over time.In these situations, it is essential that the equipment be re-qualified in order to ensure that it complies with the appropriate standards. Prior to making any changes, the organization should establish a change control process. This process should include an assessment of the affect of the proposed change, including whether the re-qualification will be a partial or full qualification.
The establishment of a robust change control process will not only help the organization maintain the long term reliability of the equipment, but will also help ensure compliance with good manufacturing practices (GMP).
Role of Installation Qualification in the Validation Lifecycle
The installation qualification process is not isolated from the other processes in the validation lifecycle, but is part of the overall validation lifecycle beginning with design and extending through regular operation.- The primary purpose of installation qualification is to ensure that the equipment is installed properly.
- The objective of operational qualification is to ensure that the equipment performs within the specified limits.
- The performance qualification process is used to confirm that equipment continues to perform consistently when used on regular basis.
- Periodic review of validation status confirms that continuous validation status is maintained.
By including installation qualification as a key part of the validation lifecycle, companies can assure equipment quality and performance in a systematic manner.
Importance of Installation Qualification
An installation qualification (IQ) is performed for many reasons. The following are examples of the benefits of a properly conducted IQ:1. Regulatory Compliance: An IQ conforms to the good manufacturing practices (GMPs) of the USFDA, Europe (EMA), World Health Organization (WHO) and Schedule M.
2. Reduction of Equipment Failures: An IQ ensures the appropriate installation and proper operation of the utilities used throughout the life of the equipment.
3. Improvement of Data Integrity: An IQ creates documentation that is traceable during an audit.
4. Assurance of Worker Safety: The safety interlocks and protective devices associated with the equipment have been checked and are functioning correctly.
5. Streamline the Validation Process: Completion of an IQ establishes a foundation on which the operation qualification (OQ) and performance qualification (PQ) can occur.
An IQ assures that the entire qualification process is valid, thus the downstream validation activities will be valid and conform to regulations.
The installation qualification is the very first stage of the qualification and validation process and is critical in ensuring that all pharmaceutical equipment or systems are properly installed, safely installed and meet all requirements of both the regulations and the design expectations.
The IQ provides evidence that the installation of the equipment or system meets the minimum requirements for the equipment or system to be operated and functioned correctly. When performed properly it will be the basis for an auditable, compliant and reliable manufacturing environment.
Combining IQ with the total validation lifecycle and the use of detailed records, pharmaceutical organizations can prove their commitment to quality, compliance and patient protection and it is the real definition of good manufacturing practice (GMP).
Frequently Asked Questions on Installation Qualification
Q 1. What is installation qualification (IQ)?
Answer: The purpose of installation qualification (IQ) is to establish documentation demonstrating the accurate installation of the system according to approved design and manufacturer's specifications.Q2. Why is IQ important in pharmaceuticals?
Answer: The primary importance of IQ for a pharmaceutical company is to confirm that the equipment is correctly set up as per current Good Manufacturing Practices (GMP) establishing a foundation for the subsequent OQ and PQ stages.Q3. What are the objectives of installation qualification?
Answer: The objectives of IQ include confirming that the installation was performed correctly, identifying any issues with the utilities required for operation, assessing employee safety and ensuring that all documentation is complete.Q4. What documents are needed for IQ?
Answer: Documentation that may be needed for IQ includes the IQ protocol, equipment manuals, calibration certificates, as well as layout drawings, factory acceptance test (FAT) and site acceptance test (SAT) reports and quality assurance (QA) approvals.Q5. Who performs installation qualification?
Answer: The engineering department performs the installation qualification, a representative from the quality assurance department reviews the process and a representative from the user department witnesses the IQ.Q6. How is IQ different from OQ and PQ?
Answer: The fundamental difference between IQ, OQ and PQ are that IQ confirms the correct installation of the equipment, OQ verifies the correct operations of the equipment and PQ verifies that equipment consistently operates as designed during normal operating conditions.Q7. When should IQ be redone?
Answer: IQ must be requalified following an equipment relocation, significant maintenance or when modifications to the equipment occur.Q8. What are key checkpoints in IQ?
Answer: Key areas of focus during IQ include establishing correct utility connections, appropriate labeling of utilities, ensuring that all equipment and utility components have been calibrated before using them, verifying that safety features are included with all equipment and verifying that the necessary IQ documentation is complete.
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