Standard Operating Procedure for Metal Detector Usage in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish a standardized procedure for the operation of metal detectors to ensure the detection and removal of metallic contaminants in ocular dosage forms, thereby ensuring product safety and compliance with regulatory requirements.

2) Scope

This SOP applies to all metal detectors used in the manufacturing process of ocular dosage forms, including eye drops, ointments, gels, and inserts, within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities include the proper operation, testing, and maintenance of metal detectors. Quality control personnel are responsible for conducting routine tests and recording the results. Production personnel are responsible for operating the metal detector and maintaining accurate records.

4) Procedure

4.1 Preparation for Metal Detector Operation

1. Ensure that the metal detector is properly installed and calibrated according to the manufacturer’s instructions.
2. Verify that the area around the metal detector is clean and free of any metallic objects that could interfere with its operation.
3. Gather all necessary tools and materials, such as test pieces, calibration records, and gloves.
4. Record the batch number, product name, and quantity of products to be inspected in the inspection logbook.

4.2 Metal Detector Operation

1. Turn on the metal detector and allow it to warm up as per the manufacturer’s instructions.
2. Conduct a sensitivity test using certified test pieces to ensure the metal detector is functioning correctly.
3. Adjust the sensitivity settings based on the product specifications and regulatory requirements.
4. Feed the products through the metal detector one at a time or in batches, ensuring a smooth and consistent flow.
5. Monitor the metal detector’s display and alarm system for any indications of metal contamination.
6. If a product triggers the metal detector’s alarm, set it aside in a designated area for further investigation.
7. Continue the inspection process until all products in the batch have been inspected.

4.3 Documentation

1. Record the results of the metal detector tests in the inspection logbook, including the number of products inspected, the number of contaminations found, and the types of metals detected.
2. Ensure that all records are signed and dated by the personnel responsible for the inspection.
3. Attach a copy of the inspection log to the batch production record for traceability.

4.4 Handling of Contaminated Products

1. Isolate contaminated products in a designated area to prevent them from being mistakenly used or distributed.
2. Investigate the cause of the contamination and document the findings in a deviation report.
3. Determine the appropriate disposition of contaminated products, such as rework, reinspection, or disposal, based on the severity and nature of the contamination.
4. Implement corrective and preventive actions (CAPA) to address the root cause of the contamination and prevent recurrence.

4.5 Review and Approval

1. The quality assurance department should regularly review testing procedures and records to ensure compliance with SOPs and regulatory requirements.
2. Any discrepancies or deviations should be investigated, documented, and resolved promptly.
3. Review and update the SOP as necessary to reflect any changes in procedures, regulations, or industry standards.

5) Abbreviations, if any

CAPA: Corrective and Preventive Actions

6) Documents, if any

1. Inspection logbook
2. Batch production record
3. Deviation report
4. Calibration records

7) Reference, if any

GMP Guidelines for Metal Detection in Pharmaceutical Products

8) SOP Version

Version 1.0