Installation Qualification IQ best value in Pharmaceuticals (23)

Installation Qualification (IQ) document is a very important document in the VMP (Validation Master Plan) of every pharmaceutical organization. Installation qualification is a documentation process, that will ensure an equipment/machine or instrument has been delivered, installed, and configured at your site in accordance with manufacturer standards and approved with the installation checklist as guided by URS and DQ (Design Qualification).IQ

Description of Document:

Describe the Installation Qualification of the Equipment, and its accessories and define the specification of the system in order to ensure that the equipment meets the specification as per URS and Design Qualification. Also, verification of the installation as per the equipment general arrangement drawing to ensure that the system installation meets acceptance criteria. Before a protocol is executed, it needs to receive approval for installation qualification.

Checking for the proper location, the correct energy supply, and the appropriate environmental conditions is included in the installation qualification paperwork of the equipment. In addition, the packing list is checked against the contents, software installation is confirmed, computer-controlled instrumentation is documented, connections are confirmed, and calibration and validation dates are recorded, among other things.

Scope: To verify the design, engineering, and manufacturing of the equipment is manufactured as per the user’s requirement and complies with the scope of supply.

Installation Qualification Tests: The below lists the tests to be performed as part of the Installation Qualification phase.

Critical Features:

  • Documents & Drawings Verification
  • Verification of Technical Specifications
  • In-House & sub-components / bought-out items
  • Utility Verification
  • Material of construction verification
  • Critical Instrument Calibration Verification

Documents & Drawings Verification:

  • Check to see if the documentation facilitates the service of the equipment and gives accurate and thorough technical references.
  • Verify that the required documents and drawings listed in DQ are available.
  • Examine the plans and papers with the installed units to ensure they are accurate and complete. Include copies of the drawings with this protocol, or make reference to where you may find them easily.
  • Any items in the installation, which are not conform to the corresponding drawings, must be commented on in the appropriate space.
  • If necessary, include a list of the non-conformances and their causes as an attachment.
  • Installation, Maintenance, and Operation Manual
  • General arrangement drawing
  • Verification of Technical Specifications for In-House & sub-components / Bought out items
  • To confirm that each key element of the equipment will confirm:
      • MODEL:
      • Type
      • Identification (Tag)
      • Manufacturer
      • Model Number
      • Confirm that the various components are as per DQ.
      • Check for tags as per specifications and in the proper number and configuration.
  • Record any deviations or inconsistencies and, if necessary, suggest taking further action.

Utility Verification:

Utility Specification Results Description
  • Electrical connection.
  • Compressed Air connection.
  • Steam connection to the heating coil
  • Chilled water for dehumidifier
  • Other if any

Material of Construction (MOC) Verification:

To verify that all assembly has been manufactured as per the specification provided in URS & DQ  and verified during FAT.

  • Testing of SS 316 material by –Moly testing unit (To identify 304 or 316 materials)
Critical Instrument Calibration Verification:

To verify that all critical instruments are calibrated before starting the Operational Qualification.

  • Check to see if all crucial instruments have been calibrated in accordance with a recognized process and a traceable standard.
  • Note any deviations or discrepancies and, if necessary, suggest taking further action.
  • Attach copies of calibration certifications to this protocol for all key instruments.

Amendment Record: Write amendment record if any

Conclusion: Write the conclusion like the equipment is compiled all the details and is qualified.

Installation Protocol includes the following points:

  • Purpose
  • Scope
  • Components Description
  • Infrastructure Identification
  • Associated Documents
  • Definitions and Acronyms
  • Hardware Identification, Installation, And Configuration Verification Instructions
  • Procedures for Testing and Hardware Installation, Configuration, and Identification
  • Components Inspection, Testing, and Verification
    • Location of installation (dimensions)
    • IPC-controlled instrumentation
    • All manuals and certifications availability
    • Equipment unpacking and cross-checking instruments
    • Check for instruments and components for damage
    • Check for power supply: Source Electric Power: [Hz, Amps, Vac, Earth]
    • Installing ancillary instruments
  • Note down the serial numbers for various components units
  • CPU Name, Cores, Type, Speed
  • RAM Memory and Cache Memory
  • Hard Drives Internal, Type, Space, etc.
  • Environmental and operating conditions, Operating Temperature, and % Relative Humidity
  • Checking software system
  • Preserving the dates of Installation Qualification tools calibration and validation
  • Verifying connections and communication with peripheral Service Clearance / Mounting
  • Accounts/Username/Password and Encryption Name, Type, etc.
  • Physical Access Protection and Fail-Over/Redundancy Feature
  • Analysis of Test Results
  • Acceptance Criteria
  • Incident Reports
  • Conclusions and Recommendations
  • Final Resolution and Approvals
  • History of Change
  • Document Approval

Need for Installation qualification in the pharmaceutical industry.

Installation Qualification (IQ) is a critical aspect of the validation process in the pharmaceutical industry. It is a documented process that ensures that equipment and systems are installed correctly and meets the manufacturer’s specifications and regulatory requirements. The need for Installation Qualification in the pharmaceutical industry can be explained as follows:

  1. Regulatory Compliance: The pharmaceutical industry is highly regulated, and regulatory agencies such as the FDA require that equipment and systems used in the manufacturing, testing, and quality control of pharmaceutical products are qualified and validated to ensure their reliability and accuracy. Installation Qualification is a critical step in meeting regulatory requirements.
  2. Ensuring Equipment Functionality: IQ ensures that the equipment is installed correctly and operates as intended by the manufacturer. This ensures that the equipment functions properly and that the data generated by the equipment is accurate and reliable.
  3. Minimizing Risks: Installation Qualification minimizes the risks associated with equipment failure, malfunction, or misalignment during the installation process. This helps to ensure that the equipment is installed correctly and is safe to use.
  4. Reducing Downtime: IQ reduces equipment downtime by identifying and correcting any installation-related issues before the equipment is put into service. This helps to avoid costly downtime, delays in production, and disruption to the manufacturing process.
  5. Improving Product Quality: IQ improves product quality by ensuring that the equipment is installed correctly and that it operates as intended. This helps to ensure that the products manufactured using the equipment are of high quality and meet the required specifications.

In conclusion, Installation Qualification is essential in the pharmaceutical industry as it ensures regulatory compliance, ensures equipment functionality, minimizes risks, reduces downtime, and improves product quality. It is a critical step in the validation process and helps to ensure that the equipment used in the manufacturing, testing, and quality control of pharmaceutical products is reliable, accurate, and safe to use.

Frequently Asked Questions:

Answer: IQ is the verification of the accessory, instruments, and physical verification of whether all the components are existing on the machine or not. But in OQ it is an ideal run of the all parts and processes of the equipment.

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