Installation Qualification of Capsule Filling Machine

 INSTALLATION QUALIFICATION REPORT 

OF 

CAPSULE FILLING MACHINE

Name of the Equipment
Name of the Department
Equipment Identification No.
Protocol No.
Issue Date
Supersedes
Reason for Change
Number of Pages

	Prepared By	Checked By	Approved By
Signature
Date
Name
Department

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

OBJECTIVE:

The objective of this protocol is:

1. To define the Installation Qualification (IQ) requirements for the Capsule Filling Machine.
2. Ensure that the equipment installed conforms to the purchase specifications & the manufacturer's recommendations.
3. To document the information that the equipment meets the acceptance criteria.

SCOPE:

The scope of this qualification exercise is limited to the installation. The respective protocol defines the procedures, documentation, references, acceptance criteria & re-qualification criteria.

QUALIFICATION TEAM:

Responsible staff from:

NAME	DEPARTMENT	DESIGNATION

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RESPONSIBILITIES:

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.

INSTALLATION PROCEDURE:

Pre-Installation:

1. Check the installation site for the fulfillment of the manufacturer’s recommendations (utilities such as electricity, etc.) and room dimensions.
2. In-house identification No: for the equipment shall be allocated.
3. Information and general layout of the equipment.
4. The location for the installation of equipment shall be made ready.

During Installation:

1. 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.
2. Check the equipment & its main components (accessories) for any damage. Write the details of the main components in FORM-B.
3. Check the utilities provided are according to the manufacturer’s recommendation. Refer FORM-C.
4. The material of construction of the components. Refer FORM-D.
5. Check the change parts if any with the machine supplied. Refer FORM-E.
6. Details of the lubricants, which should be used in the operation of the machine and its specifications. Refer FORM-F.
7. Check the manuals received for completeness. Mention the equipment manuals in FORM-G.
8. Check the drawings received for completeness. FORM-H.
9. 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.
10. Prepare an IQ report comprising of Observations made, problems encountered, a summary of deviation report, results of any tests & any other relevant information.

Acceptance Criteria:

1. The installation of Capsule Filling Machine fulfills the selection criteria and purpose of the application, in accordance with the protocol.
2. The Capsule Filling Machine is installed and verified as per the procedure given in the protocol.

RE-QUALIFICATION CRITERIA:

Re-qualification of the equipment is applicable when

1. Modification or change in main component.
2. Equipment is sent for major repairing.
3. Equipment is transferred from one location to another.

FORMS:

FORM A

Details of Equipment:

Name of the Equipment
Identification No.
Manufacturer’s Name & Address
Make/Model
Overall Dimension in mm (W x L x H)
Material of Construction
Weight of the Machine
Location for Installation
Purpose
Main Components of the Equipment

Description of Equipment:

1. 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.
2. 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.
3. The capsule-filling machine operates in the following sequence.
4. Loading and separation of capsules cap from the body.
5. Powder filling of capsules into the capsule body half.
6. Rejoining of the capsules cap with the body and ejection of the filled capsules.

FORM B

List of Components

Sr. No.	DESCRIPTION	Checked By
1
2
3
4
5
6
7.

FORM C

Utilities Requirement

Sr. No.	Utility	Specified	Observed	Engg. Sign & Date
1.	Electric supply
	Load
	Voltage
	Phase
	Frequency
2.	Compressed Air
3.	Max. Consumption of Air
4.	Earthing

FORM D

Material of Construction for The Components

Sr. No	Component	MOC	Contact Part Yes/No	Identification No./Sr. No.	Date/Sign (Engg.)
1
2
3
4
5
6

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FORM E

Change Parts Details

Sr. No.	CHANGE PARTS	QUANTITY	CHECKED BY
1.
2.

 

FORM F

Lubricant Chart

Sr. No.	Description	Location	Contact Part Yes/No	Type of Lubricant
1.
2.
3.
4.
5.
6.

 

FORM G

List of Manuals

Sr. No.	Manual	Manual Recd./ Not Recd.	Date & Signature (Engg.)
1.	Instruction
2.	Installation
3.	Operation
4.	Maintenance

 

FORM H

List of Drawing

Sr. No.	Drawing Title	Recd./Not Recd.	File Location	Date & Signature (Engg.)
1.	Electrical Drawing
2.	Schematic Diagram

 

FORM I

Deviation Report

Deviation(s):

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 Justification for acceptance:

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

Name
Signature
Date
Department	Engineering	Head Q.A.
	Prepared By	Verified By

N.A. - = Not Applicable

SUMMARY & APPROVAL OF INSTALLATION QUALIFICATION:

Summary:

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Approval:

Installation Qualification (IQ) is satisfactory                                                              

  Hence can proceed to Operation Qualification (OQ)                                       

 

Name
Signature
Date
Department	Engineering	Head Q.A.
	Prepared By	Verified By

CHECK LIST FOR INSTALLATION QUALIFICATION:

Sr. No.	List	Enclosed/Not Closed	Sign/Date Engg.
1.	FORM A: Details of equipment
2.	FORM B: Details of main components
3.	FORM C: Utilities requirement
4.	FORM D: Material of construction
5.	FORM E: Change parts
6.	FORM F: Lubrication chart
7.	FORM G: Details of manuals
8.	FORM H: Drawings
9.	FORM I: Deviation report
10.	Summary & Approval of Installation Qualification

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