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 or spectroscopic methods.
    4.3.3 Compare impurity profiles against reference standards or previous batches to identify and characterize impurities.
    4.3.4 Document chromatograms, spectra, or other relevant data as per method requirements.

4.4 Calculation and Interpretation:
    4.4.1 Calculate the percentage of impurities relative to the API concentration using validated formulas.
    4.4.2 Evaluate impurity levels against acceptance criteria specified in pharmacopeial standards or internal specifications.
    4.4.3 Investigate and document any unexpected impurities or deviations from expected results.

4.5 Acceptance Criteria:
    4.5.1 API impurity levels should be within acceptable limits defined by regulatory authorities and internal quality standards.
    4.5.2 Ensure all analytical controls and method validation parameters meet predefined criteria.

4.6 Documentation:
    4.6.1 Record all impurity profiling procedures, results, and observations in the Impurity Profiling Record.
    4.6.2 Maintain detailed records of method development, sample preparation, testing conditions, and any deviations encountered.
    4.6.3 Review and approve the documentation by QC Manager.

5) Abbreviations, if any

QC: Quality Control
API: Active Pharmaceutical Ingredient
HPLC: High Performance Liquid Chromatography
GC: Gas Chromatography
LC-MS: Liquid Chromatography-Mass Spectrometry
NMR: Nuclear Magnetic Resonance

6) Documents, if any

Impurity Profiling Record
Method Validation Report for Impurity Profiling
Sampling Plan Document

7) Reference, if any

ICH guidelines for Analytical Method Validation
Pharmacopeial standards for Impurity Profiling of APIs

8) SOP Version

Version 1.0