INSTALLATION QUALIFICATIONS OF DISPENSING BOOTH

INSTALLATION QUALIFICATIONS OF DISPENSING BOOTH

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
  • Critical Instrument Calibration Verification
  • Installation Qualification Tests Status
• Data Analysis, Summary of IQ & Recommendations
• Amendment Record
• Conclusion

• PURPOSE

To describe the Installation Qualification of Dispensing Booth, its accessories and to define the Specification of the system in order to:

• 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.

• SCOPE:

The scope of this document applies to the installation qualification of Dispensing booth  and its accessories to be installed at Sano Cito Therapeutic Inc. (Unit-II).Vill. Loharan P.O. Ghatti, Solan -173211 (H.P)

• RESPONSIBILITIES:
  • It is the responsibility of the Validation Team to prepare and check installation qualification protocol.
  • It is the responsibility of the Quality Assurance approve the installation qualification protocol.

• PROCEDURE

The following requirement / practices apply to Klenzaids Bioclean Devices (P) Ltd., Dispensing Booth, Installation Qualification activities:

• Verify that systems are installed in accordance
  • General arrangement drawing.
  • Installation specification; and
• 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.

• Documents & Drawings Verification

• Rationale –

To verify that the documentation provides complete and correct technical references and permits servicing of the units.

• Test equipment –

Not 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 to this document 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.
• Drawing Verification Results:

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 Klenzaids Product, Dispensing Booth, are present and identified.

• Test Equipment

None Required

• Procedure
  • Confirm that identification nameplates 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 Klenzaids Product, Dispensing Booth, are 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 drawings must be present, documented and tagged.

• Major Components Results

Conclusions / Comments:

PASS                                      FAIL

Verified By:                ________________________            Date:   ______________

Reviewed By:                         ________________________            Date:   ______________

• 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

Conclusions / Comments:

PASS                                      FAIL

Verified By:                ________________________            Date:   ______________

Reviewed By:                         ________________________            Date:   ______________

• Material of Construction Verification

• Rationale –

To verify that all assembly of Klenzaids Product, Dispensing Booth 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 SS 316 & if the solution turns pink and immediately vanishes, then it is SS 304

• Acceptance Criteria
  • All material of construction for the Klenzaids Product, Dispensing Booth, shall meet SS 304 std.
  • Material other than SS316 and SS304 are verified based on their material testing certificates provided by the Manufacturer.

• Material of Construction verification Results

Conclusions / Comments:

PASS                                      FAIL

Verified By:                ________________________            Date:   ______________

Reviewed By:                         ________________________            Date:   ______________

• Critical Instrument Calibration Verification

• Rationale-

To verify that all critical instrument for the Dispensing Booth has been calibrated before starting the Operational Qualification.

• Procedure-
  • Verify that all critical instruments are calibrated using an approved procedure, against a traceable standard.
  • Note any deviations or discrepancies and recommend follow up actions if required.
  • For all critical instruments, attach copies of calibration certificate to this protocol.
• Acceptance Criteria

All critical instrumentation for Open Fronted Containment Facilities shall be in a state of calibration.

• Critical Instrument Calibration Verification

Conclusions / Comments:

PASS                                      FAIL

Verified By:                ________________________            Date:   ______________

Reviewed By:                           _______________________            Date:   ______________

• Installation Qualification Tests Status

The table below lists the tests performed and related results.

• Data ANALYSIS, Summary of IQ & Recommendations

   7.0       AMENDMENT RECORD

    Note : Any changes made in the system must be recorded in this sheet.

8.0   CONCLUSION

Prepared by                                                     Reviewed by                                       Approved by