Standard Operating Procedure for Ointment Preparation 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 preparation system to ensure the consistent and safe production of ocular ointments in compliance with regulatory requirements.

2) Scope

This SOP applies to all ointment preparation systems used in the manufacturing of ocular dosage forms, including ointments, within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities include the proper operation, monitoring, cleaning, and maintenance of the ointment preparation system. Production personnel are responsible for operating the system and maintaining accurate records. Quality control personnel are responsible for verifying the preparation process and ensuring compliance with SOPs.

4) Procedure

4.1 Preparation for Ointment Preparation

1. Ensure that the ointment preparation area is clean, well-organized, and free from contaminants.
2. Verify that all equipment, utensils, and materials needed for ointment preparation are available and in good condition.
3. Calibrate the ointment preparation system according to the manufacturer’s instructions to ensure accurate measurements and mixing.
4. Record the batch number, product name, and quantity of raw materials to be used in the batch production log.

4.2 Ointment Preparation Process

1. Raw Material Weighing and Verification
   1. Weigh the required quantities of raw materials, such as base ingredients, active ingredients, and excipients, using calibrated weighing scales.
   2. Verify the weighed quantities against the batch production record to ensure accuracy.
   3. Record the weights and verification results in the batch production log.
2. Mixing Process
   1. Add the weighed raw materials to the mixing vessel in the specified order.
   2. Start the mixer and set it to the specified speed and duration for the initial mixing phase.
   3. Monitor the mixing process to ensure that all ingredients are uniformly dispersed.
   4. Adjust the mixing speed and duration as necessary to achieve the desired ointment consistency.
3. Heating and Cooling (if applicable)
   1. If the ointment preparation requires heating, set the heating system to the specified temperature and duration.
   2. Monitor the temperature and stirring process to ensure uniform heating.
   3. After the heating phase, allow the ointment to cool to the specified temperature under controlled conditions.
4. Quality Control Checks
   1. Take samples of the prepared ointment for quality control testing, including viscosity, pH, and active ingredient content.
   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.
5. Final Homogenization
   1. Perform final homogenization of the ointment to ensure uniformity and consistency.
   2. Set the homogenizer to the specified speed and duration for the final mixing phase.
   3. Monitor the homogenization process and make any necessary adjustments to achieve the desired ointment properties.
6. Transfer and Storage
   1. Transfer the prepared ointment to a designated storage container under controlled conditions to prevent contamination.
   2. Label the storage container with the batch number, product name, and date of preparation.
   3. Store the container in a controlled environment as specified in the product storage requirements.

4.3 Cleaning and Maintenance

1. Clean the ointment preparation 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 preparation process, including raw material weights, mixing parameters, and quality control results, in the batch production log.
2. Ensure that all records are signed and dated by the personnel responsible for the preparation.
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 preparation 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