Sunday , July 5 2020
Home / Validation & Qualification / Qualification / Installation Qualification(IQ) / Template for Installation Qualification Protocol

Template for Installation Qualification Protocol

Template for Installation Qualification ProtocolPURPOSE

  • To describe the Installation Qualification procedure to be used during qualification of Name of Equipment machine to define the Specification of the system in order to
  • Ensure that the equipment meets the specification as per Design Qualification (Doc Number).
  • Aid verification of the installation as per equipment general arrangement drawing
  • Ensure that the system installation meets acceptance criteria
  • Ensure that the equipments will be installed in accordance with current Good manufacturing Practices      ( cGMP)
  • SCOPE
  • This procedure applies to the installation qualification of Name of Equipment.
  • RESPONSIBILITIES
  • It is the responsibility of the manufacturer to prepare the installation qualification protocol as per Design Qualification
  • It is the responsibility of the client to check and approve the installation qualification protocol.
  • It is the responsibility of the manufacturer to perform all the specifications verification checks and tests with respect to installation qualification and compiling data in co-ordination with client.
  • PROCEDURE
  • The following requirement / practices apply to Name of Equipment, Installation Qualification activities:
  • Verify that major components are tagged or labelled with a unique ID number.
  • Verify that the equipment and instrumentation are clearly described as per vendor, model, capacity, materials of construction and any critical criteria.
  • Verify that systems are installed in accordance with approved engineering drawings and documents, which shall include the following
    • General arrangement drawing.
    • Installation specification; and
    • Equipment manuals
  • INSTALLATION QUALIFICATION TESTS
  • The table below lists the tests to be performed as part of the Installation Qualification phase.
TEST NUMBER CRITICAL FEATURE
5.1 Documents & Drawings Verification
5.2 Verification of Technical Specification for

In-House & sub-components / bought out items

5.3 Utilities Verification
5.4 Material of construction verification
  • Documents & Drawings Verification
  • Rationale – To verify that the documentation provides complete and correct technical references and permits servicing of the units.
  • Test equipment – None Required.
  • Procedure :
    • Verify that the required documents and drawings
    • Review the documents and drawings for completeness and exactness with the installed units.
    • Attach the copies of the drawings or reference the location from where they can be easily retrieved.
    • Any items in the installation, which are not conforming to the corresponding drawings, must be commented on in the appropriate space. List the non-conformances and the reasons for them in an attachment if necessary.
  • Acceptance Criteria :
    • The documents must be accurate and complete.
    • The drawing information must correspond to the physical installation.
  • Documentation Verification Results.
S.No Description Document No Verified By Date
1 Installation, Operation and Maintenance Manual
2 General arrangement drawing
  • Conclusions / Comments:
  • PASS                                    FAIL
  • Verified By:     _______________________           Date:   ______________
  • Checked By: ________________________            Date:     ______________

 

  • Verification of Technical Specification for In-House & sub-components / Bought out items
  • Purpose
  • To verify that each major component of the Name of Equipment, is present and identified.
  • Test Equipment
  • None Required
  • Note any deviations or discrepancies and recommend follow up action if required.
  • Confirm that the various components of Name of Equipment, is present and tagged as per specifications and drawings, in the proper number and configuration.
  • Model Number
  • Manufacturer
  • Identification (Tag)
  • Type
  • Confirm that identification name plates have been applied to the units and that these indicate the following (where applicable).
  • Procedure
  • Acceptance Criteria
  • All units and parts specified in design qualification and on latest revision of drawings must be present, documented and tagged.
  • Components Result (The rows shall be increased/ decreased as per requirement.)
Description Specification Meets

Spec. (Yes/No)

Verification Source Initials Date
1.                   


Utilities Verification

  • Rationale – To verify that all necessary utilities are correctly installed.
  • Procedure :
  • Confirm that utilities connections are configured as per specification and in compliance with local codes.
  • Record the results in the table below. Note any deviations or discrepancies.
  • Acceptance Criteria
  • All services and connections must be installed and documented.
  • Utilities Specification Results (The rows shall be increased/ decreased as per

requirement.)

Description Specified Observation Initial / Date

mm/dd/yy

  • Conclusions / Comments:
  • PASS                                    FAIL
  • Verified By:               ________________________           Date:   ______________
  • Reviewed By:            ________________________           Date:   _____________

 

  • Material of Construction Verification
  • Rationale – To verify that all assembly of Name of Equipment, has been manufactured as per the specification provided by the customer.
  • Test equipment – Moly testing unit (To identify 304 or 316 materials)
  • Procedure :
  • Put a drop of Molybdenum solution on the material to be tested.
  • Take battery & keep anode at one end of the material and cathode at Moly drop.
  • If the solution turns pink and stays for around one minute, then it is SS316 & if the solution turns pink and immediately vanishes, then it is SS304.
  • Acceptance Criteria
  • All material of construction for the Name of Equipment, shall meet the MOC provided in Design Qualification.
  • Material other than SS316 and SS304 are verified based on their material testing certificates provided by the Manufacturer.
  • Material of Construction verification Results (The rows shall be increased/ decreased as per )
Description Specification Meets

Spec. (Yes/No)

Verification Source Initials Date
  • Reviewed By:  ________________________           Date:   ______________
  • Verified By:     ________________________           Date:   ______________
  • PASS                                    FAIL
  • Conclusions / Comments

 

  • Installation Qualification Tests Status
  • The table below lists the tests performed and related results.
Test Number

 

Critical Feature

 

Pass / Fail Deviation Found
Pass Fail Yes No
Documents & Drawings Verification
Verification of Technical Specification for In-House & Sub-contract / bought out items.
Utilities Verification
Material of Construction Verification

 

  • Data Analysis, Summary of IQ & Recommendations
  • AMENDMENT RECORD
S. No. Item Name Remarks Signature & Date
  • Note: Any changes made in the system must be recorded in this sheet.

 

  • CONCLUSION

More Jobs UpdatesVisit@ http://pharmaguidances.com

 

 

About Pharma Editor

Check Also

Performance Qualification for Auto Coater 48’’ GMP Model

TABLE OF CONTENTS 1.0 Approval 2.0 Objective 3.0 Responsibility 4.0 System Description 4.1 Equipment Identification …