Sampling of Finished Vaginal Dosage Forms

1) Purpose

The purpose of this SOP is to establish the procedure for sampling finished vaginal dosage forms to ensure that samples are representative of the entire batch for quality testing.

2) Scope

This SOP applies to all personnel involved in the sampling of finished vaginal dosage forms at the pharmaceutical facility.

3) Responsibilities

The Quality Control (QC) Department is responsible for conducting the sampling of finished products as per this SOP. The Production Department is responsible for providing the QC Department with access to the finished products for sampling.

4) Procedure

4.1 Preparation for Sampling

1. Ensure all sampling tools and containers are clean and sterilized.
2. Review the batch record to determine the quantity of samples required.

4.2 Sampling Method

1. Select samples randomly from different locations within the batch to ensure representativeness.
2. Follow the sampling plan defined in the product specification or batch record.
3. Use aseptic techniques to prevent contamination during sampling.

4.3 Handling and Storage of Samples

1. Immediately transfer the samples to labeled, sterile containers.
2. Store the samples under specified conditions until testing.

4.4 Documentation

1. Document the sampling process, including date, time, batch number, and quantity of samples taken.
2. Record any deviations or issues encountered during sampling.

4.5 Sample Testing

1. Send the samples to the QC laboratory for testing as per the defined protocols.
2. Document and review test results to ensure they meet quality standards.

5) Abbreviations, if any

QC: Quality Control

6) Documents, if any

Batch record, sampling plan, sample log

7) Reference, if any

FDA Guidance for Industry: Process Validation: General Principles and Practices, ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0