Standard Operating Procedure for Installation Qualification (IQ) of Capsule Filling Machines

Department	Capsule Manufacturing
SOP No.	SOP/CM/166/2025
Supersedes	SOP/CM/166/2022
Page No.	Page 1 of 9
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

The purpose of this SOP is to outline the Installation Qualification (IQ) process for capsule filling machines. IQ is an essential step in the validation of new or modified equipment to ensure that it is installed correctly, meets design specifications, and is suitable for use in capsule production. This SOP ensures compliance with GMP and regulatory standards and provides a systematic approach to documenting the IQ process.

2. Scope

This SOP applies to the Installation Qualification (IQ) of all capsule filling machines used in the manufacturing process. It covers the installation procedures, checks, and documentation necessary to validate that the equipment is installed in compliance with design specifications and operational requirements.

3. Responsibilities

• Engineering Team: Responsible for installing the capsule filling machine and ensuring that it meets all installation specifications. The team is also responsible for performing all the installation checks outlined in this SOP.
• Quality Control (QC) Team: Responsible for verifying and documenting the results of the IQ process, including inspecting the equipment for compliance with the specifications and performing functional checks.
• Quality Assurance (QA) Team: Responsible for reviewing and approving the IQ documentation to ensure compliance with GMP and regulatory requirements.
• Production Team: Responsible for ensuring the equipment is properly integrated into the production environment and is ready for use after successful completion of the IQ process.

4. Accountability

The Engineering Supervisor is responsible for ensuring the installation of the capsule filling machine according to the design specifications. The QA Manager is responsible for reviewing and approving the IQ documentation to ensure compliance with GMP and regulatory standards. The Production Supervisor is responsible for ensuring the equipment is ready for use after successful IQ completion.

5. Procedure

5.1 Pre-Installation Setup

Before starting the installation of the capsule filling machine, ensure the following preparations are completed:

1. Review Installation Plan
   1. Review the installation plan provided by the manufacturer, which should include equipment specifications, installation requirements, and validation protocols.
2. Prepare Installation Environment
   1. Ensure the installation environment meets the required specifications for the capsule filling machine, including space, electrical connections, and environmental conditions such as temperature and humidity.
   2. Verify that the installation area is clean, well-lit, and free of any obstructions.
3. Calibrate and Verify Tools
   1. Ensure all tools and calibration equipment required for installation are verified and calibrated before use. Record calibration details in the Equipment Calibration Log (Annexure 1).

5.2 Installation of Capsule Filling Machine

Follow these steps to install the capsule filling machine:

1. Unpack and Inspect Equipment
   1. Carefully unpack the capsule filling machine and verify that all parts are present according to the manufacturer’s packing list. Inspect the equipment for any visible damage during shipping.
2. Assemble the Machine
   1. Assemble the machine according to the manufacturer’s instructions. Ensure all components are securely fastened, and all connections are properly made.
3. Electrical and Mechanical Connections
   1. Connect the machine to the appropriate electrical supply, ensuring all safety protocols are followed during installation. Check all mechanical connections, such as drive motors, belts, and gears, for proper alignment.

5.3 Installation Checks and Verification

Perform the following checks to ensure the capsule filling machine is installed correctly:

1. Verify Electrical and Mechanical Functionality
   1. Test the electrical connections to ensure that the machine powers on without any faults. Verify that all mechanical systems, including the filling mechanism, motor, and controls, function correctly.
2. Verify Equipment Alignment
   1. Ensure that all parts of the machine, including the capsule loading mechanism, filling station, and sealing system, are correctly aligned and calibrated according to the manufacturer’s specifications.
3. Verify Machine Performance
   1. Perform a test run of the machine without capsules to verify the operation of the filling process and ensure that all components operate smoothly. Record the results in the Installation Qualification Log (Annexure 2).
4. Document Installation Results
   1. Document the results of the installation checks, including any issues encountered and corrective actions taken, in the Installation Qualification Report (Annexure 3).

5.4 Post-Installation Activities

After successful installation, perform the following tasks:

1. Verify Equipment Readiness
   1. Verify that all machine settings are correct and that the machine is ready for operation. Ensure that all safety checks, such as emergency stops and guard positions, are in place.
2. Provide Operator Training
   1. Train the operators on the proper use of the capsule filling machine, including safety protocols, machine settings, and basic troubleshooting procedures.
3. Sign-Off and Approval
   1. Ensure that the installation qualification process is completed to satisfaction, and the machine is signed off by the QA Manager for use in production. The Installation Qualification Report should be approved and filed for record-keeping.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• IQ: Installation Qualification
• QA: Quality Assurance
• QC: Quality Control
• PPE: Personal Protective Equipment

7. Documents

1. Annexure 1: Equipment Calibration Log
2. Annexure 2: Installation Qualification Log
3. Annexure 3: Installation Qualification Report

8. References

• FDA Guidelines on Equipment Installation Qualification
• Good Manufacturing Practice (GMP) Guidelines
• USP <1058> – Equipment Qualification

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure 1: Equipment Calibration Log

Equipment ID	Calibration Date	Operator	Calibration Details	Next Calibration Due
Filling Machine 204	01/02/2025	John Doe	Calibration of filling speed and weight	01/02/2026

Annexure 2: Installation Qualification Log

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Annexure 2: Installation Qualification Log

Batch ID	Installation Date	Operator	Installation Parameters	Remarks
Batch 001

Batch ID	Installation Date	Operator	Installation Parameters	Remarks
Batch 001	02/02/2025	Jane Smith	Voltage: 220V, Pressure: 3 bars	Installation successful, no issues

Annexure 3: Installation Qualification Report

Batch ID	Test Date	Test Type	Results	Remarks
Batch 001	02/02/2025	Visual Inspection	Pass	Machine installed correctly, no issues found

12. Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial version of SOP	Creation of SOP for Installation Qualification of capsule filling machines	QA Head
01/02/2025	2.0	Updated installation procedures and added new testing criteria	Improvement of installation checks and addition of test parameters	QA Head