Filling and Sealing Procedures for Vaginal Dosage Forms

1) Purpose

The purpose of this SOP is to outline the procedure for filling and sealing vaginal dosage forms to ensure consistency, quality, and sterility of the final product.

2) Scope

This SOP applies to all personnel involved in the filling and sealing of vaginal dosage forms at the pharmaceutical manufacturing facility.

3) Responsibilities

The Production Department is responsible for carrying out the filling and sealing operations as per this SOP. The Quality Assurance (QA) Department is responsible for monitoring and verifying the process.

4) Procedure

4.1 Preparation

1. Ensure that the filling and sealing equipment is clean, sterilized, and set up according to the manufacturer’s instructions.
2. Verify that the raw materials and components (e.g., containers, closures) are approved and available for use.
3. Check environmental conditions (temperature, humidity, cleanliness) in the filling and sealing area.

4.2 Filling Process

1. Start the filling machine and set it to the required fill volume as specified in the batch record.
2. Perform a trial run to ensure the fill volume and consistency are within acceptable limits.
3. Commence the filling operation, ensuring that each container is filled accurately and consistently.
4. Monitor the filling process for any deviations or issues and document them accordingly.

4.3 Sealing Process

1. Set up the sealing machine and ensure it is operating correctly.
2. Feed the filled containers into the sealing machine, ensuring proper alignment and positioning.
3. Monitor the sealing process to ensure a secure and consistent seal on each container.
4. Perform regular checks on sealed containers to verify seal integrity.

4.4 Post-Operation

1. Inspect the filled and sealed containers for any defects or inconsistencies.
2. Document the filling and sealing operation in the batch record, including any deviations or issues encountered.
3. Clean and sterilize the filling and sealing equipment according to the standard cleaning procedure.

5) Abbreviations, if any

QA: Quality Assurance

6) Documents, if any

Batch record, equipment log, cleaning record

7) Reference, if any

FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice, ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0