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 attributes (CQAs) during qualification runs.
3. Analyze data to demonstrate that the process consistently produces products meeting predetermined specifications.

4.3 Continued Process Verification

1. Establish a plan for ongoing monitoring and verification of qualified processes.
2. Implement statistical process control (SPC) techniques to monitor process performance and detect trends or deviations.
3. Periodically review process data and performance metrics to ensure continued compliance and identify opportunities for process improvement.

4.4 Process Validation Maintenance

1. Update process validation documentation in response to changes in equipment, materials, or process parameters.
2. Revalidate processes periodically as per defined schedules or in response to significant changes that may affect product quality.
3. Maintain accurate records of process validation activities, including protocols, reports, and validation summary documents.

5) Abbreviations, if any

SOP: Standard Operating Procedure
CPPs: Critical Process Parameters
CQAs: Critical Quality Attributes
QA: Quality Assurance
SPC: Statistical Process Control

6) Documents, if any

1. Process Qualification Protocol
2. Batch Records for Qualification Batches
3. Process Validation Reports
4. Process Flow Diagrams
5. Updated SOPs for Qualified Processes

7) Reference, if any

Good Manufacturing Practices (GMP) guidelines
International Conference on Harmonization (ICH) guidelines
Regulatory requirements for process validation

8) SOP Version

Version 1.0