Standard Operating Procedure for Qualification of Strip Packaging Machines
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying strip packaging machines used in pharmaceutical manufacturing. This SOP ensures that the strip packaging machines are correctly installed, operate according to specifications, and perform consistently under typical production conditions. The qualification process verifies the mechanical, electrical, and operational parameters of the strip packaging machine, ensuring that the packaging process meets the required regulatory and quality standards for pharmaceutical products.
2) Scope
This SOP applies to the qualification of strip packaging machines used in the pharmaceutical industry for packaging tablets, capsules, and other solid dosage forms in strip packaging formats. The qualification process includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). The SOP is applicable to both new machines and machines that have undergone major repairs, upgrades, or relocations. It ensures that the packaging machine operates effectively and meets predefined quality standards such as sealing integrity, packaging accuracy, and product protection.
3) Responsibilities
Operators: Responsible for assisting in the IQ, OQ, and PQ processes, ensuring that the strip packaging machine is operated according to the qualification protocols and that critical
Quality Assurance (QA): Ensures that the IQ, OQ, and PQ of the strip packaging machine are carried out in compliance with this SOP and meet all regulatory requirements. QA is responsible for reviewing and approving all qualification reports and documentation.
Production Supervisors: Oversee the qualification processes to ensure that operators follow the protocol and that the machine operates within the specified parameters.
Validation Team: Responsible for developing the qualification protocols, executing the IQ, OQ, and PQ runs, and analyzing the results to ensure the strip packaging machine meets all performance criteria.
Maintenance Personnel: Ensures that the strip packaging machine is properly installed, maintained, and calibrated, and that all mechanical and electrical systems are functioning correctly during the qualification process.
4) Procedure
The following steps should be followed for the IQ, OQ, and PQ of strip packaging machines:
1. Installation Qualification (IQ):
1.1 Review equipment specifications and manufacturer manuals to ensure that the strip packaging machine meets the necessary requirements for installation.
1.2 Verify that all necessary utilities (e.g., electrical power, compressed air, cooling systems) are available and meet the specifications required for machine operation.
1.3 Ensure that the installation site meets the required environmental conditions such as temperature, humidity, cleanliness, and space.
1.4 Confirm that all mechanical components are correctly installed, including the film feeding system, sealing jaws, cutting system, and product alignment mechanisms.
1.5 Ensure that all electrical components, including sensors, control systems, and alarms, are properly connected and functioning.
1.6 Perform a visual inspection to confirm that the equipment is installed according to the manufacturer’s instructions and that all components are intact.
1.7 Complete the IQ documentation, including checklists, equipment manuals, and relevant installation records, ensuring that all information is recorded and signed off by responsible personnel.
2. Operational Qualification (OQ):
2.1 Verify that all operational controls, such as film feed rate, sealing temperature, sealing pressure, and cut-off settings, are properly set and calibrated.
2.2 Conduct an empty run of the strip packaging machine to verify that it operates without issues. Monitor key parameters such as film tension, sealing consistency, and system alignment.
2.3 Test all control systems, ensuring that the start/stop, film tension controls, sealing mechanisms, and reject functions are working correctly.
2.4 Inspect the packaging process to ensure that the machine is effectively sealing the packaging material without damaging the tablets or capsules.
2.5 Verify that the machine consistently produces properly formed and sealed strips with no defects such as uneven seals, improperly cut packaging, or misaligned product.
2.6 Document the results of the OQ, noting any deviations or issues encountered and corrective actions taken.
3. Performance Qualification (PQ):
3.1 Conduct the packaging process using product tablets or capsules and monitor performance under typical production conditions.
3.2 Perform sampling during the packaging cycle to measure packaging accuracy, ensuring that the correct number of tablets or capsules are placed in each package.
3.3 Verify the integrity of the sealed packages by checking for leaks, poor seals, or other defects that could compromise product protection.
3.4 Measure the packaging throughput to ensure that the machine operates within acceptable production rates without compromising packaging quality.
3.5 Perform visual inspection of the finished strip packs to confirm that the appearance meets product standards and that there are no visible defects or improper seals.
3.6 Document the results of the PQ, including packaging efficiency, sealing integrity, and any process deviations. Ensure that all records are signed and reviewed by responsible personnel.
4. Documentation and Reporting:
4.1 Record all data during the IQ, OQ, and PQ processes, including batch records, equipment logs, process parameters, and inspection results for packaging accuracy, sealing integrity, and throughput.
4.2 Ensure that all forms, reports, and certificates are completed and signed by responsible personnel.
4.3 Perform statistical analysis on the collected data to assess the consistency and reliability of the packaging process. This analysis should confirm that the machine operates consistently within predefined parameters and meets the acceptance criteria.
4.4 Prepare a final qualification report, summarizing the results of the IQ, OQ, and PQ, including any deviations, corrective actions, and conclusions regarding the strip packaging machine’s performance.
5. Requalification:
5.1 Requalify the strip packaging machine if significant changes are made to the equipment, such as replacing major components, relocating the machine, or modifying the sealing system.
5.2 Periodically perform requalification to ensure that the equipment continues to perform as expected and remains in compliance with regulatory requirements.
5) Abbreviations
- IQ: Installation Qualification
- OQ: Operational Qualification
- PQ: Performance Qualification
- QA: Quality Assurance
- SOP: Standard Operating Procedure
6) Documents
- IQ/OQ/PQ Protocol
- Equipment Manufacturer Specifications
- Installation and Setup Reports
- Calibration Records
- Packaging Process Records
- Sealing Integrity Logs
- Throughput and Packaging Accuracy Records
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: IQ/OQ/PQ Test Record
| Date | Time | Operator Initials | Test Type (IQ/OQ/PQ) | Test Results | Comments |
|---|---|---|---|---|---|
| DD/MM/YYYY | HH:MM | Operator Name | IQ/OQ/PQ | Pass/Fail | Comments |
Template 2: Sealing Integrity Test Log
| Batch No. | Test Date | Seal Integrity Test Result | Packaging Accuracy (Pass/Fail) | Operator Initials |
|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Pass/Fail | Pass/Fail | Operator Name |
Template 3: Packaging Throughput Log
| Batch No. | Test Date | Packaging Speed (Units/Min) | Rejection Rate (%) | Operator Initials |
|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Speed | Rejection Rate | Operator Name |