1) Purpose

The purpose of this SOP is to establish procedures for the control and monitoring of manufacturing processes in the production of ocular dosage forms to ensure product quality and consistency.

2) Scope

This SOP applies to all process control systems and measures implemented within the facility to regulate and monitor critical manufacturing processes for ocular dosage forms.

3) Responsibilities

Quality assurance personnel are responsible for overseeing the implementation and compliance of this SOP. Production personnel are responsible for adhering to procedures outlined in this document.

4) Procedure

4.1 Process Monitoring and Control

1. Set up and calibrate process control instruments according to manufacturer’s specifications.
2. Monitor critical process parameters such as temperature, pressure, flow rates, and pH continuously during manufacturing.
3. Implement control measures to ensure process parameters remain within specified limits.

4.2 Process Validation

1. Validate manufacturing processes according to approved protocols and regulatory guidelines.
2. Document and review process validation results to ensure compliance with predetermined criteria.

4.3 Process Adjustments and Corrective Actions

1. Authorize adjustments to process parameters based on validated procedures and documented changes.
2. Implement corrective actions promptly in response to deviations or non-conformances identified during process monitoring.

4.4 Process Documentation

1. Maintain accurate records of process parameters, adjustments, and monitoring activities.
2. Document changes to manufacturing processes and obtain necessary approvals before implementation.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

1. Process validation protocols and reports
2. Process control instrument calibration records
3. Process monitoring logs

7) Reference, if any

GMP Guidelines for Pharmaceutical Manufacturing

8) SOP Version

Version 1.0