Standard Operating Procedure for Cleaning Validation in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to define the procedures for cleaning validation to ensure that all equipment used in the manufacturing of ocular dosage forms is cleaned effectively to prevent cross-contamination and ensure product quality and safety.

2) Scope

This SOP applies to all equipment and facilities involved in the manufacturing process of ocular dosage forms, including mixing equipment, filling machines, packaging machinery, and manufacturing areas. It encompasses validation of cleaning procedures and verification of cleanliness.

3) Responsibilities

The Quality Assurance (QA) department is responsible for implementing and overseeing cleaning validation activities. Production personnel are responsible for executing cleaning procedures as per approved protocols. Engineering and technical support teams provide expertise for cleaning validation and equipment maintenance.

4) Procedure

4.1 Cleaning Validation Protocol Development

1. Identify equipment and critical process areas that require cleaning validation based on risk assessment and regulatory requirements.
2. Develop cleaning validation protocols specifying acceptance criteria, sampling methods, and analytical techniques.
3. Include worst-case scenarios and challenging conditions in the cleaning validation protocol.

4.2 Cleaning Procedure Execution

1. Implement approved cleaning procedures following documented instructions and using validated cleaning agents and tools.
2. Perform visual inspection and swab sampling of equipment surfaces post-cleaning to verify cleanliness.
3. Collect samples for