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INSTALLATION QUALIFICATION PROTOCOL FOR COATING MACHINE

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 of Coating Machine and to define the Specification of the system in order to:

  • ensure that the equipment meets the intended specification.
  • aid verification of the installation as per equipment general arrangement
  • 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 Coating Machine to be installed at Pharmaceutical company.

  • RESPONSIBILITIES:
    • It is the responsibility of the Validation Team to prepare and check the installation qualifications protocol.
    • It is the responsibility of the Quality Assurance to approve the installation qualification protocol.
    • It is the responsibility of the Validation Team to perform and check all the specifications verification checks with respect to installation qualifications protocol and compiling data.
    • It is the responsibility of the Quality Assurance to approve the installation qualification. 
  • PROCEDURE
    • The following requirement/practices apply to Coating Machine installation

qualifications activities:

Verify that system is installed in accordance with approved engineering drawings and documents which shall include the following.

  • Equipment manuals.
  • Installation specification; and.
  • General arrangement drawing.
  • 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
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

 

  • 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 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.
  • Documentation Verification Results.
Sr. No. Description Document No Verified By Date
1 Installation, Operation and Maintenance Manual
2 General arrangement drawing

 

  • Verification of Technical Specification for In-House & sub-components /

Bought out items 

  • Purpose

To verify that each major component of the Coating Machine 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 Coating Machine 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 and on latest revision of drawings must be present, documented and tagged.
  • Major Components Results
Description Specification Meets

Spec. (Yes/No)

Verification Source Signature Date
1.                  Equipment Description
Name Coating Machine
Make Chamunda Pharma
Machine No. 51/7
Model CPM C36 GMP
Capacity 32 Kg
Specification Non Flame proof construction
Overall dimensions 1680 mm(L) X  920 mm(W) X  1500 mm(H)
2.                  Main Motor
Sr. No. 69028396
Model Flange Mounted
Power Rating 3Ph / 50 Hz / 415 V / 1.5 HP
Make NGEF
RPM 1440
3.                  Worm Reduction Gear Box
Sr. No. 4R 56185
Type A337
Ratio 70/1
Make Greaes Gears
4.                  V – Belt
Belt No. B62/1575
Make Rilton Roulunds
Qty. 01
5.                  Blower Motor
Sr. No. 69028274
Model Flange Mounted
Power Rating 3Ph / 50 Hz / 415 V / 0.5 HP
Make NGEF
RPM 1365
6.                  Electric Heater
Power Rating 3 kw
Location Blower Assembly
7.                  Temp. Adjustment Dial
Location Above Main Motor Covering
Range 0-110 0 C
Least Count 50C
8.                  Control Panel
Main Motor START / STOP Switch 01 No. Each
Blower Motor START / STOP Switch 01 No. Each
Machine ON Indicator 01 No.
  • Equipment Number Identification

 

Equipment Name Sr. No. Equipment no.

(If applicable)

Checked By Date
Main Motor        _______
Blower Motor        _______
Worm Reduction Gear Box        _______

 

 

5.3.1    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. Note any deviations or discrepancies.

 

  • Acceptance Criteria
    • All services and connections must be installed and documented.
  •  Utilities Specification Results
Description Specified Observation Initial / Date
Electrical connection To be provided

 

  • Material of Construction Verification 
  • Rationale –

To verify that all assembly of Coating Machine has been manufactured as per the specification provided by the customer.

  • Test equipment –

Moly testing unit (To identify SS 304 or SS 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 Coating Machine shall meet the MOC mentioned in Specification Column.
    • Material other than SS 316 and SS 304 are verified based on their material testing certificates provided by the Manufacturer.
  • Material of Construction verification Results
Description Specification Meets

Spec. (Yes/No)

Verification Source Signature Date
Coating Pan SS 316
Hot Air SS braided hose SS 316

 

 

  • 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

 

Sr. No. Item Name Remarks Signature and Date

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

  • CONCLUSION

 

 

 

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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