Guidelines for Labeling and Batch Coding of Vaginal Dosage Forms

1) Purpose

The purpose of this SOP is to outline the procedures for labeling and batch coding of vaginal dosage forms to ensure correct identification and traceability throughout the manufacturing process.

2) Scope

This SOP applies to all personnel involved in the labeling and batch coding of vaginal dosage forms in the pharmaceutical manufacturing facility.

3) Responsibilities

The Production Department is responsible for carrying out labeling and batch coding activities. The Quality Assurance (QA) Department is responsible for verifying and ensuring compliance with this SOP.

4) Procedure

4.1 Preparation for Labeling and Batch Coding

1. Ensure that all labeling and batch coding equipment is calibrated and in good working condition.
2. Verify that the correct labels and batch coding materials are available and properly stored.
3. Review the batch records to confirm the details required for labeling and batch coding.

4.2 Labeling Process

1. Retrieve the approved labels from the storage area and verify their accuracy against the batch record.
2. Affix labels to the vaginal dosage forms or their packaging in accordance with the specifications outlined in the batch record.
3. Ensure that labels are applied evenly, securely, and without any creases or misalignment.

4.3 Batch Coding Process

1. Set up the batch coding equipment with the correct