Procedure for Impurity Profiling

1) Purpose

The purpose of this SOP is to outline the procedure for conducting impurity profiling of Active Pharmaceutical Ingredients (APIs) to ensure their purity and compliance with regulatory standards.

2) Scope

This SOP applies to all APIs used in pharmaceutical manufacturing within the facility that require impurity profiling as per regulatory requirements.

3) Responsibilities

Quality Control (QC) Department: Responsible for performing impurity profiling and ensuring compliance with this SOP.
Production Department: Responsible for providing API samples and supporting QC during impurity profiling.

4) Procedure

4.1 Method Development and Validation:
    4.1.1 Develop and validate analytical methods for impurity profiling based on API characteristics.
    4.1.2 Validate method specificity, sensitivity, accuracy, and precision according to ICH guidelines.
    4.1.3 Document method validation results and obtain approval from QC Manager.

4.2 Sample Handling and Preparation:
    4.2.1 Obtain representative samples of the API from the production department or quarantine area.
    4.2.2 Ensure samples are properly identified, labeled, and stored under appropriate conditions.
    4.2.3 Prepare sample solutions or suspensions as per validated methods and dilutions if necessary.

4.3 Impurity Profiling Procedure:
    4.3.1 Perform impurity profiling using validated analytical techniques, such as HPLC, GC, LC-MS, or NMR.
    4.3.2 Separate and quantify impurities present in the API sample using appropriate chromatographic