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

1) Purpose

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

2) Scope

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

3) Responsibilities

Batch 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 Batch Record Review and Approval

1. Review batch records to ensure completeness, accuracy, and compliance with approved procedures.
2. Verify that all raw materials, equipment, and process parameters are documented according to specifications.
3. Approve batch records for production based on established criteria.

4.2 Batch Processing

1. Follow approved batch records and standard operating procedures (SOPs) during batch processing.
2. Monitor critical process parameters and document deviations or adjustments made during processing.
3. Ensure that in-process checks and controls are performed at specified intervals.

4.3 Batch Release and Quality Assurance Checks

1. Verify completion of all production and quality control activities outlined in the batch record.
2. Perform final quality assurance checks, including visual inspection and testing, before batch release.
3. Document and approve batch release based on established acceptance criteria.

4.4 Batch Documentation and Recordkeeping

1. Maintain accurate and complete records of batch processing activities, including deviations, investigations, and corrective actions.
2. Archive batch records and associated documentation as per regulatory requirements.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

1. Batch production records
2. Batch release certificates
3. Deviation and investigation reports

7) Reference, if any

Good Manufacturing Practice (GMP) guidelines for pharmaceutical manufacturing

8) SOP Version

Version 1.0