Standard Operating Procedure for Ointment Mixing System in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish a standardized procedure for the operation, cleaning, and maintenance of the ointment mixing system to ensure uniform and consistent mixing of ointments for ocular dosage forms.

2) Scope

This SOP applies to all ointment mixing systems used in the manufacturing of ocular dosage forms within the pharmaceutical manufacturing facility.

3) Responsibilities

Production personnel are responsible for operating the ointment mixing system and maintaining accurate records. Quality control personnel are responsible for verifying the mixing process and ensuring compliance with SOPs.

4) Procedure

4.1 Preparation for Ointment Mixing

1. Ensure the mixing area is clean, organized, and free from contaminants.
2. Verify the availability and condition of all equipment, utensils, and materials needed for the mixing process.
3. Calibrate the ointment mixing system according to the manufacturer’s instructions to ensure proper mixing parameters.
4. Record the batch number, product name, and quantity of ointment to be mixed in the batch production log.

4.2 Ointment Mixing Process

1. Preparation of Mixing Equipment
   1. Assemble the mixing system components as per the manufacturer’s instructions.
   2. Sanitize all parts that come into contact with the ointment using appropriate disinfectants.
   3. Set up the mixing system with the required mixing parameters (speed, time, etc.).
2. Mixing Operation
   1. Load the ointment ingredients into the mixing system hopper or reservoir.
   2. Start the mixing system and begin the mixing process.
   3. Monitor the mixing process to ensure uniform and consistent mixing of the ointment.
   4. Perform in-process checks for mix uniformity and consistency at regular intervals.
3. Quality Control Checks
   1. Take samples of the mixed ointment for quality control testing, including uniformity and consistency.
   2. Record the results of the quality control tests in the batch production log.
   3. If any parameters are out of specification, investigate and take corrective actions before proceeding.
4. Transfer and Storage
   1. Transfer the mixed ointment to the designated containers for storage or further processing.
   2. Label the containers with the batch number, product name, and other required information.
   3. Store the containers in a designated area under controlled conditions.

4.3 Cleaning and Maintenance

1. Clean the ointment mixing system and all associated equipment thoroughly after each batch according to the cleaning SOP.
2. Inspect the system for any signs of wear or damage and perform necessary maintenance or repairs.
3. Record all cleaning and maintenance activities in the equipment logbook.

4.4 Documentation

1. Record the details of the ointment mixing process, including mixing parameters, in-process checks, and quality control results, in the batch production log.
2. Ensure that all records are signed and dated by the personnel responsible for the mixing.
3. Attach a copy of the batch production log to the batch production record for traceability.

4.5 Review and Approval

1. The quality assurance department should regularly review mixing procedures and records to ensure compliance with SOPs and regulatory requirements.
2. Any discrepancies or deviations should be investigated, documented, and resolved promptly.
3. Review and update the SOP as necessary to reflect any changes in procedures, regulations, or industry standards.

5) Abbreviations, if any

SOP: Standard Operating Procedure

CAPA: Corrective and Preventive Actions

6) Documents, if any

1. Batch production log
2. Batch production record
3. Equipment logbook

7) Reference, if any

GMP Guidelines for Pharmaceutical Manufacturing

8) SOP Version

Version 1.0