INSTALLATION QUALIFICATION REPORT
OF
CAPSULE FILLING MACHINE
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Equipment Identification No. |
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Protocol No. |
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| Prepared By | Checked By | Approved By |
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TABLE OF CONTENTS:
Sr. No | Title |
1.0 | Table of contents |
2.0 | Objective |
3.0 | Scope |
4.0 | Qualification Team |
5.0 | Responsibilities |
6.0 | Installation Procedure |
7.0 | Acceptance criteria |
8.0 | Re-qualification criteria |
9.0 | FORMS: |
FORM A: Details of Equipment | |
FORM B: Details of main components | |
FORM C: Utility requirement | |
FORM D: MOC of the component | |
FORM E: Details of change parts if any | |
FORM F: Lubrication | |
FORM G: List of manuals | |
FORM H: List of drawing | |
FORM I: Deviation Report | |
10.0 | Summary & Approval of Installation Qualification |
11.0 | Checklist for Installation Qualification |
- To define the Installation Qualification (IQ) requirements for the Capsule Filling Machine.
- Ensure that the equipment installed conforms to the purchase specifications & the manufacturer's recommendations.
- To document the information that the equipment meets the acceptance criteria.
NAME | DEPARTMENT | DESIGNATION |
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Responsibilities | Details |
Vendor | Supplying drawings, manuals and necessary documents for the generation and implementation of this protocol. |
Engineering | Initial receipt and inspection of incoming equipment, drawings & certificates. Preparation of description reports of equipment and its various components. Preparation of written procedures for preventive maintenance of the equipment and its components. Engineering Head will check the protocol and report. |
QA | Preparation of this protocol in assistance with the Engineering department. Audit & review the data documented during equipment qualification & ensure that it meets the acceptance criteria. Final approval of Protocol & report. |
- Check the installation site for the fulfillment of the manufacturer’s recommendations (utilities such as electricity, etc.) and room dimensions.
- In-house identification No: for the equipment shall be allocated.
- Information and general layout of the equipment.
- The location for the installation of equipment shall be made ready.
- Compare equipment, as received, with the purchase order and write the equipment details in FORM-A. Attach a copy of the purchase order as an annexure.
- Check the equipment & its main components (accessories) for any damage. Write the details of the main components in FORM-B.
- Check the utilities provided are according to the manufacturer’s recommendation. Refer FORM-C.
- The material of construction of the components. Refer FORM-D.
- Check the change parts if any with the machine supplied. Refer FORM-E.
- Details of the lubricants, which should be used in the operation of the machine and its specifications. Refer FORM-F.
- Check the manuals received for completeness. Mention the equipment manuals in FORM-G.
- Check the drawings received for completeness. FORM-H.
- Any deviation observed during the qualification study shall be recorded in FORM-I & the manufacturer shall be informed. If the deviation is minor & is not going to affect the routine performance of the equipment, IQ study may be completed with proper justification.
- Prepare an IQ report comprising of Observations made, problems encountered, a summary of deviation report, results of any tests & any other relevant information.
- The installation of Capsule Filling Machine fulfills the selection criteria and purpose of the application, in accordance with the protocol.
- The Capsule Filling Machine is installed and verified as per the procedure given in the protocol.
- Modification or change in main component.
- Equipment is sent for major repairing.
- Equipment is transferred from one location to another.
Name of the Equipment |
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Identification No. |
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Manufacturer’s Name & Address |
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Make/Model |
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Overall Dimension in mm (W x L x H) |
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Material of Construction |
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Weight of the Machine |
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Location for Installation |
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Purpose |
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Main Components of the Equipment |
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- The machine is best suited to meet the needs of Pharmaceuticals. It serves to specifically reduce the fatigue of the operator making it easy to operate with automation of the loading, filling, and closing sections.
- The Semi-Automatic Capsule Filling Machine is designed to fill Hard Gelatin Capsules. Capsules from size 00 to size 2 can be filled with powder, granules or pellets.
- The capsule-filling machine operates in the following sequence.
- Loading and separation of capsules cap from the body.
- Powder filling of capsules into the capsule body half.
- Rejoining of the capsules cap with the body and ejection of the filled capsules.
FORM B
List of ComponentsSr. No. | DESCRIPTION | Checked By |
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FORM C
Utilities RequirementSr. No. | Utility | Specified | Observed | Engg. Sign & Date |
1. | Electric supply | |||
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Voltage |
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Frequency |
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2. | Compressed Air |
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3. | Max. Consumption of Air |
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4. | Earthing |
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FORM D
Sr. No | Component | MOC | Contact Part Yes/No | Identification No./Sr. No. | Date/Sign (Engg.) |
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ALSO READ: SOP for Operating Procedure of Manual Capsule Filling Machine
FORM E
Change Parts DetailsSr. No. | CHANGE PARTS | QUANTITY | CHECKED BY |
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FORM F
Sr. No. | Description | Location | Contact Part Yes/No | Type of Lubricant |
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2. |
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4. |
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5. |
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6. |
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FORM G
Sr. No. | Manual | Manual Recd./ Not Recd. | Date & Signature (Engg.) |
1. | Instruction |
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2. | Installation |
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3. | Operation |
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4. | Maintenance |
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FORM H
List of DrawingSr. No. | Drawing Title | Recd./Not Recd. | File Location | Date & Signature (Engg.) |
1. | Electrical Drawing |
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2. | Schematic Diagram |
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FORM I
Deviation Report
Deviation(s):
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Justification for acceptance:
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Department | Engineering | Head Q.A. |
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N.A. - = Not Applicable
SUMMARY & APPROVAL OF INSTALLATION QUALIFICATION:
Summary:
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Approval:
Installation Qualification (IQ) is satisfactory
Name |
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Department | Engineering | Head Q.A. |
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CHECK LIST FOR INSTALLATION QUALIFICATION:
Sr. No. | List | Enclosed/Not Closed | Sign/Date Engg. |
1. | FORM A: Details of equipment |
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2. | FORM B: Details of main components |
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3. | FORM C: Utilities requirement |
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4. | FORM D: Material of construction |
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5. | FORM E: Change parts |
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6. | FORM F: Lubrication chart |
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7. | FORM G: Details of manuals |
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8. | FORM H: Drawings |
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9. | FORM I: Deviation report |
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10. | Summary & Approval of Installation Qualification |
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ALSO READ: Performance Qualification Protocol for Fluid Bed Dryer