Guidelines for Sampling of Finished Vaginal Dosage Forms

1) Purpose

The purpose of this SOP is to establish a procedure for the sampling of finished vaginal dosage forms to ensure that the samples taken are representative of the batch and comply with quality standards.

2) Scope

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

3) Responsibilities

The Quality Control (QC) Department is responsible for performing the sampling of finished products. The Quality Assurance (QA) Department ensures compliance with this SOP.

4) Procedure

4.1 Preparation for Sampling

1. Ensure that the sampling area and equipment are clean and free from any contaminants.
2. Review the batch record to determine the quantity of samples required.
3. Verify that the sampling containers are clean, labeled, and suitable for the purpose.

4.2 Sampling Procedure

1. Randomly select units from the batch of finished vaginal dosage forms as per the sampling plan.
2. Use appropriate tools (e.g., sterile tweezers, gloves) to handle the dosage forms to avoid contamination.
3. Place the selected samples in labeled containers, ensuring that they are properly sealed to prevent contamination.
4. Record the details of the sampling in the batch record, including the number of units sampled and their identification numbers.

4.3 Handling and Storage of Samples

1. Store the samples under conditions that maintain their integrity, as specified in the batch record.
2. Ensure that the samples are transported to the QC laboratory promptly for analysis.

4.4 Quality Control Testing

1. Submit the samples to the QC laboratory for testing as per the specified methods.
2. Record the results of the QC tests in the relevant documentation.
3. Report any out-of-specification results to the QA Department for further investigation.

4.5 Documentation

1. Document all sampling activities in the batch record, including the date, time, and personnel involved.
2. Maintain records of QC test results, any deviations, and corrective actions taken.
3. Retain sampling records in accordance with the company’s document retention policy and regulatory requirements.

5) Abbreviations, if any

QC: Quality Control
QA: Quality Assurance

6) Documents, if any

Batch record, sampling plan, QC test results 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