Standard Operating Procedure for Installation Qualification (IQ) of Tablet Compression Machines
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for performing Installation Qualification (IQ) for tablet compression machines in pharmaceutical manufacturing. This SOP ensures that the tablet compression machine is installed according to manufacturer specifications and meets regulatory requirements. The IQ process verifies that the equipment is correctly installed, and all components are functioning as expected before moving on to the next stages of equipment qualification (Operational Qualification and Performance Qualification).
2) Scope
This SOP applies to the installation qualification of all tablet compression machines used in the pharmaceutical manufacturing process. It covers the installation process, including the verification of equipment, utilities, environment, and documentation required for proper operation. This SOP is applicable to new machines, as well as existing machines that have undergone major repairs or modifications.
3) Responsibilities
Operators: Responsible for assisting with the IQ process, ensuring that the machine is operated according to the manufacturer’s instructions and all parameters are verified.
Quality Assurance (QA): Ensures that the installation of the tablet compression machine complies with this SOP and all applicable regulations. QA is also responsible
Production Supervisors: Oversee the installation process to ensure that all necessary steps are followed and documented. They also ensure that operators are trained and the process is performed according to the approved protocol.
Validation Team: Responsible for developing and executing the Installation Qualification protocol, ensuring that all system components are verified according to the specifications.
Maintenance Personnel: Responsible for ensuring that the tablet compression machine is installed and set up correctly and that all utilities, mechanical, and electrical components are functioning as required.
4) Procedure
The following steps should be followed for the Installation Qualification (IQ) of tablet compression machines:
1. Pre-Installation Preparation:
1.1 Review equipment manuals and specifications provided by the manufacturer to ensure that the tablet compression machine meets all necessary requirements for installation.
1.2 Verify that all required utilities (electrical, compressed air, vacuum, etc.) are available and meet the necessary specifications for the equipment.
1.3 Ensure that the installation site meets the required environmental conditions (e.g., temperature, humidity, cleanliness) as specified by the equipment manufacturer and regulatory guidelines.
1.4 Prepare and ensure that all necessary tools and resources are available for the installation process.
1.5 Confirm that the machine has been delivered with all components intact, including manuals, spare parts, and accessories.
2. Equipment Installation:
2.1 Install the tablet compression machine according to the manufacturer’s instructions, ensuring all mechanical and electrical components are properly connected.
2.2 Verify the proper installation of all system components such as tablet die sets, feed frames, compression rollers, and control panels.
2.3 Ensure that all safety features, such as emergency stops, protective covers, and safety interlocks, are correctly installed and functional.
2.4 Set up the necessary electrical and mechanical connections, including grounding, to ensure proper operation.
2.5 Perform a visual inspection to confirm that the installation complies with both the manufacturer’s instructions and the specifications outlined in the installation qualification protocol.
3. Verification of Installation:
3.1 Verify that the tablet compression machine is properly calibrated by checking factory-set parameters and comparing them with the manufacturer’s specified settings.
3.2 Inspect the operation of critical machine components, including the tablet press motor, feeders, punches, dies, and ejection systems, to ensure that they are functioning as expected.
3.3 Check the alignment of tablet punches, dies, and compression rollers to confirm that they are positioned correctly and working properly.
3.4 Test the electrical system to ensure that the machine is properly wired, all circuits are connected, and control panels function correctly.
3.5 Ensure that all operator and safety controls are functioning and accessible. Verify that the machine stops when the emergency stop button is pressed and that all safety features are active.
3.6 Conduct a system check to verify that the machine communicates properly with other systems, such as the batch recording system or supervisory control systems, if applicable.
4. Environmental and Utility Check:
4.1 Verify that all utilities (electrical, compressed air, and other relevant systems) are available and meet the specifications required for the tablet compression machine’s operation.
4.2 Perform checks to ensure that the air quality, temperature, and humidity are within the acceptable range for operation, as specified by the manufacturer.
4.3 Ensure that any water or fluid systems connected to the equipment are functioning properly and are free from leaks or contamination.
4.4 Confirm that the machine is installed in an appropriate environment, meeting cleanliness, safety, and regulatory standards.
5. Documentation and Reporting:
5.1 Complete the Installation Qualification Protocol, documenting all verification checks and results.
5.2 Ensure that all relevant forms and reports are signed and dated by responsible personnel, including operators, maintenance personnel, and QA staff.
5.3 Compile a report summarizing the results of the IQ, including any deviations or issues encountered during installation, corrective actions taken, and final approval status.
5.4 Retain all installation qualification documentation in accordance with internal documentation control procedures and regulatory requirements.
5.5 Prepare for the next stage of qualification, such as Operational Qualification (OQ), once the IQ process is successfully completed and approved.
6. Requalification:
6.1 Perform requalification of the tablet compression machine if significant modifications are made to the equipment, or if the machine is moved or relocated.
6.2 Periodically review and verify the installation process, particularly if any major changes occur to the equipment or surrounding environment.
5) Abbreviations
- QA: Quality Assurance
- OQ: Operational Qualification
- IQ: Installation Qualification
- OEE: Overall Equipment Effectiveness
- SOP: Standard Operating Procedure
6) Documents
- Installation Qualification Protocol
- Equipment Manufacturer Specifications
- Electrical and Mechanical Setup Reports
- Equipment Calibration Logs
- Process Validation Reports
- Sign-Off Sheets
7) Reference
- FDA Guidance for Industry: Equipment Qualification
- International Council for Harmonisation (ICH) Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- ISO 9001: Quality Management Systems – Requirements
- USP Chapter 1151: Pharmaceutical Dosage Forms
8) SOP Version
Version 1.0 – Effective Date: DD/MM/YYYY
Annexure
Template 1: Installation Qualification Checklist
| Date | Time | Operator Initials | Checklist Item | Pass/Fail |
|---|---|---|---|---|
| DD/MM/YYYY | HH:MM | Operator Name | Item to be verified | Pass/Fail |
Template 2: Equipment Installation Log
| Batch No. | Installation Date | Component Installed | Serial No. | Operator Initials |
|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Component Name | Serial Number | Operator Name |
Template 3: Final Equipment Inspection Record
| Batch No. | Inspection Date | Inspection Method | Result | Operator Initials |
|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Inspection Method | Pass/Fail | Operator Name |