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 batch number, expiration date, and other relevant information as specified in the batch record.
2. Conduct a trial run to ensure that the batch coding is accurate and legible.
3. Batch code each unit of the vaginal dosage form or its packaging, verifying that the information is clear and consistent.

4.4 Verification and Quality Control

1. Conduct regular checks during the labeling and batch coding processes to ensure accuracy and consistency.
2. Record any discrepancies or issues encountered during the process and take corrective actions as necessary.
3. Submit samples of labeled and batch-coded vaginal dosage forms to the QA Department for final verification and approval.

4.5 Documentation

1. Document the labeling and batch coding activities in the batch record, including details of the labels and batch codes used.
2. Maintain records of any deviations, corrective actions, and QA approvals.
3. Retain labeling and batch coding records in accordance with the company’s document retention policy and regulatory requirements.

5) Abbreviations, if any

QA: Quality Assurance

6) Documents, if any

Batch record, label specification sheet, batch coding log

7) Reference, if any

ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, WHO Good Manufacturing Practices: main principles for pharmaceutical products

8) SOP Version

Version 1.0