TEMPLATE FOR INSTALATION QUALIFICATION PROTOCOL

TEMPLATE FOR  INSTALLATION QUALIFICATION PROTOCOL

TABLE OF CONTENT

  • Purpose
  • Scope
  • Responsibilities
  • Procedure
  • Installation Qualification tests
    • Documents & Drawings Verification
    • Verification of Technical Specification for In-House & sub-components / Bought

out items

  • Utilities Verification
  • Material of Construction Verification
  • Installation Qualification Tests Status
  • Data Analysis, Summary of IQ & Recommendations
  • Amendment Record
  • Conclusion
  • PURPOSE

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 to be installed at Pharmaceutical Company Name with Location.

  • 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 systems are installed in accordance with approved engineering drawings and documents, which shall include the following
    • General arrangement drawing.
    • Installation specification; and
    • Equipment manuals
  • Verify that the equipment and instrumentation are clearly described as per vendor, model, capacity, materials of construction and any critical criteria.
  • Verify that major components are tagged or labelled with a unique ID number.

 

  • 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 listed in the table 5.1.5 is available.
    • 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

  • Procedure
    • Confirm that identification name plates have been applied to the units and that these indicate the following (where applicable).
  • Type
  • Identification (Tag)
  • Manufacturer
  • Model Number
    • Confirm that the various components of Name of Equipment, is present and tagged as per specifications and drawings, in the proper number and configuration.
    • Note any deviations or discrepancies and recommend follow up action if required.
  • 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

 

Conclusions / Comments:

 

 

PASS                                      FAIL

Verified By:                ________________________            Date:   ______________

Reviewed By:             ________________________            Date:   ______________

 

  •  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
5.1 Documents & Drawings Verification
5.2 Verification of Technical Specification for In-House & Sub-contract / bought out items.
5.3 Utilities Verification
5.4 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

 

 

Prepared by                              Reviewed By                                     Approved by

 

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