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Ensure that the equipment meets the specification as per Design Qualification (Doc Number).
Ensure that the equipments will be installed in accordance with current Good manufacturing Practices (
cGMP)
SCOPE
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
Equipment manuals
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6/16/2020 Template for Installation Qualification Protocol - Pharmaceutical Guidance
The table below lists the tests to be performed as part of the Installation Qualification phase.
5.2
In-House & sub-components / bought out items
Rationale – To verify that the documentation provides complete and correct technical references and
Procedure :
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 :
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6/16/2020 Template for Installation Qualification Protocol - Pharmaceutical Guidance
Conclusions / Comments:
PASS FAIL
Veri cation of Technical Speci cation 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
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.
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6/16/2020 Template for Installation Qualification Protocol - Pharmaceutical Guidance
Meets
Veri cation
Description Speci cation Spec. Initials Date
Source
(Yes/No)
1.
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
requirement.)
Initial / Date
Conclusions / Comments:
PASS FAIL
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6/16/2020 Template for Installation Qualification Protocol - Pharmaceutical Guidance
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 :
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
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 )
Meets
Veri cation
Description Speci cation Spec. Initials Date
Source
(Yes/No)
PASS FAIL
Conclusions / Comments
The table below lists the tests performed and related results.
Utilities Verification
AMENDMENT RECORD
Note: Any changes made in the system must be recorded in this sheet.
CONCLUSION
Pharma Editor
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