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

1) Purpose

The purpose of this SOP is to establish procedures for the control and management of production activities in the manufacturing of ocular dosage forms to ensure efficiency and compliance with regulatory requirements.

2) Scope

This SOP applies to all production control activities and measures implemented within the facility to oversee and regulate the production of ocular dosage forms.

3) Responsibilities

Production supervisors and managers are responsible for implementing and maintaining compliance with this SOP. Quality assurance personnel are responsible for verifying adherence to procedures and standards.

4) Procedure

4.1 Production Planning and Scheduling

1. Develop production schedules based on demand forecasts and resource availability.
2. Coordinate with procurement and logistics departments to ensure availability of raw materials and packaging components.
3. Review and update production schedules as necessary to optimize efficiency and meet production targets.

4.2 Batch Record Preparation

1. Prepare batch records containing detailed instructions and specifications for each production batch.
2. Include information on raw materials, equipment used, process parameters, and in-process controls.
3. Ensure batch records are reviewed and approved before the start of production.

4.3 Production Operation

1. Ensure production personnel are trained and qualified to perform assigned tasks.
2. Follow batch records and standard operating procedures (SOPs) during production activities.
3. Monitor and record critical process parameters to ensure consistency and compliance with specifications.

4.4 Cleaning and Maintenance

1. Implement cleaning and sanitization procedures for equipment and production areas.
2. Schedule and perform preventive maintenance to ensure equipment reliability and operational efficiency.
3. Document cleaning and maintenance activities in logbooks and records.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

1. Production batch records
2. Production schedules
3. Cleaning and maintenance logs

7) Reference, if any

Good Manufacturing Practice (GMP) guidelines for pharmaceutical manufacturing

8) SOP Version

Version 1.0