Standard Operating Procedure for Visual Inspection of Filled Ampoules

1) Purpose

The purpose of this SOP is to establish a standardized procedure for the visual inspection of filled ampoules to ensure their quality, integrity, and compliance with regulatory requirements for ocular dosage forms.

2) Scope

This SOP applies to all filled ampoules containing ocular dosage forms, including sterile eye solutions and other injectable products, produced within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities include the proper inspection, documentation, and handling of filled ampoules. Quality control personnel are responsible for conducting the visual inspection and recording the results. Production personnel are responsible for presenting filled ampoules for inspection and maintaining accurate records.

4) Procedure

4.1 Preparation for Inspection

1. Ensure that the inspection area is clean, well-lit, and free from distractions.
2. Calibrate the inspection equipment, if applicable, to ensure accurate results.
3. Gather all necessary inspection tools, such as magnifying glasses, light boxes, and gloves.
4. Record the batch number, product name, and quantity of ampoules to be inspected in the inspection logbook.

4.2 Visual Inspection Process

1. Inspect each ampoule individually by holding it against a light source to check for any visible defects or contamination.
2. Check for the following potential defects:
   1. Particulate matter or foreign particles
   2. Cracks, chips, or other damage to the ampoule
   3. Improper fill level or leakage
   4. Labeling errors or illegible labels
   5. Discoloration or cloudiness of the solution
3. Use a magnifying glass for a closer inspection of any suspected defects.
4. Set aside any ampoules with defects in a separate, labeled area for further investigation.
5. Continue the inspection process until all ampoules in the batch have been inspected.

4.3 Documentation

1. Record the results of the visual inspection in the inspection logbook, including the number of ampoules inspected, the number of defects found, and the types of defects identified.
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 Defective Ampoules

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

4.5 Review and Approval

1. The quality assurance department should regularly review inspection 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

7) Reference, if any

GMP Guidelines for Visual Inspection of Parenteral Products

8) SOP Version

Version 1.0