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 that the impurity levels in the tested samples meet the specified acceptance criteria based on compendial standards or product specifications.
2. Document any deviations from acceptance criteria and investigate root causes if necessary.

4.5 Reporting and Documentation

1. Document all testing activities, including results and any deviations, in the appropriate logbooks and records.
2. Prepare an impurity testing report summarizing the findings for each batch tested.
3. Review and approve the testing report to ensure accuracy and compliance with regulatory requirements.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

6) Documents, if any

Impurity Testing Protocol, Testing Records, Testing Reports, Sample Collection and Preparation Records

7) Reference, if any

Regulatory guidelines such as ICH Q3A (R2) Impurities in New Drug Substances, European Pharmacopoeia (Ph. Eur.) 2.2.46 Related Substances

8) SOP Version

Version 1.0