Standard Operating Procedure for Process Qualification in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish the procedures for process qualification to ensure that all manufacturing processes involved in the production of ocular dosage forms consistently produce products of desired quality that meet predefined specifications and regulatory requirements.

2) Scope

This SOP applies to all manufacturing processes used in the production of ocular dosage forms, including but not limited to mixing, filling, sterilization, packaging, and labeling. It encompasses qualification of new processes, changes to existing processes, and ongoing process verification.

3) Responsibilities

The Quality Assurance (QA) department is responsible for implementing and overseeing process qualification activities. Production personnel are responsible for executing qualified processes according to approved procedures. Engineering and technical support teams provide expertise for process validation and improvement.

4) Procedure

4.1 Process Design and Development

1. Define and document the critical process parameters (CPPs) and their acceptable ranges based on product specifications and quality attributes.
2. Conduct risk assessment to identify potential process risks and mitigation strategies.
3. Develop process flow diagrams, batch records, and standard operating procedures (SOPs) for new or modified processes.

4.2 Process Qualification (PQ)

1. Execute qualification batches using the documented process parameters, equipment, and materials.
2. Monitor and record process parameters and critical quality