Standard Operating Procedure for Impurity Testing

1) Purpose

This SOP outlines the procedures for conducting impurity testing on pharmaceutical raw materials and products.

2) Scope

This SOP applies to impurity testing of raw materials, intermediate products, and finished pharmaceutical products in the manufacturing facility.

3) Responsibilities

The Quality Control (QC) department is responsible for performing impurity testing. Production personnel are responsible for sample preparation. Quality Assurance (QA) oversees the process and ensures compliance with this SOP and regulatory requirements.

4) Procedure

4.1 Preparation

1. Review the impurity testing protocol and ensure all necessary materials and equipment are available (e.g., chromatography system, reference standards).
2. Verify the calibration and functionality of the chromatography system.

4.2 Sample Collection and Preparation

1. Collect representative samples of raw materials or products according to sampling procedures.
2. Prepare the samples by ensuring they are properly labeled and identified.
3. If necessary, prepare the samples by extracting or diluting according to the impurity testing method.

4.3 Testing Procedure

1. Prepare the chromatography system according to the impurity testing method (e.g., column equilibration, mobile phase preparation).
2. Inject the sample into the chromatography system and run the analysis according to the method parameters.
3. Identify and quantify impurities using suitable detection techniques (e.g., UV-Vis, MS).
4. Perform impurity testing in duplicate or as per protocol requirements.

4.4 Acceptance Criteria

1. Ensure