Standard Operating Procedure for Contamination Control System in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish procedures for the operation and maintenance of the contamination control system to prevent contamination of ocular dosage forms during manufacturing.

2) Scope

This SOP applies to all contamination control measures and systems within the facility that are designed to maintain cleanliness and prevent contamination during the manufacturing process of ocular dosage forms.

3) Responsibilities

Facility management and quality assurance personnel are responsible for ensuring compliance with this SOP. Operations personnel are responsible for following procedures outlined in this SOP.

4) Procedure

4.1 Monitoring and Control

1. Regularly monitor environmental conditions using calibrated instruments.
2. Implement measures to control contamination sources in manufacturing areas.
3. Monitor and maintain cleanliness of production equipment and facilities.

4.2 Cleaning and Disinfection

1. Develop and follow cleaning and disinfection procedures for manufacturing areas and equipment.
2. Use approved cleaning agents and methods according to validated procedures.
3. Ensure thorough cleaning of critical surfaces and equipment between batches.

4.3 Personnel Hygiene

1. Enforce strict personnel hygiene practices, including gowning and hand hygiene protocols.
2. Provide regular training to personnel on contamination control measures and practices.

4.4 Material and Equipment Handling

1. Ensure proper handling and storage of raw materials and components to prevent contamination.
2. Validate cleaning procedures for equipment used in manufacturing processes.

4.5 Monitoring and Documentation

1. Maintain records of environmental monitoring results and contamination control activities.
2. Document any deviations from established procedures and corrective actions taken.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

1. Contamination control plan
2. Cleaning validation reports
3. Environmental monitoring records

7) Reference, if any

GMP Guidelines for Pharmaceutical Manufacturing

8) SOP Version

Version 1.0