12/4/2020 Template for Installation Qualification Protocol - Pharmaceutical Guidance

Template for Installation Qualification Protocol

 Pharma Editor  October 27, 2016  Installation Qualification(IQ), Validation & Qualification  7,129 Views

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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. 
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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

Verification of Technical Specification for

5.2
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.
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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

Installation, Operation and

1
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

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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.)

Meets
Verification
Description Specification Spec. Initials Date
Source
(Yes/No)

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.)

Initial / Date

Description Specified Observation

mm/dd/yy

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Conclusions / Comments:

PASS FAIL

Verified By: ________________________ Date: ______________

Reviewed By: ________________________ Date: _____________

Pharma APIs & Intermediates

Pharma APIs and intermediates of anti-virus, anti-cancer, anti-
diabetic drugs, etc.

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 )

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Meets

Verification
Description Specification Initials Date
Source

Spec. (Yes/No)

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 Deviation

Pass / Fail
Found

Pass Fail Yes No

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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

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