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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