Standard Operating Procedure for Elemental Impurity Testing

1) Purpose

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

2) Scope

This SOP applies to elemental 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 elemental 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 elemental impurity testing protocol and ensure all necessary materials and equipment are available (e.g., ICP-MS instrument, calibration standards).
2. Verify the calibration and functionality of the ICP-MS instrument.

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 digestion or any other specified method for elemental impurity testing.

4.3 Testing Procedure

1. Prepare the ICP-MS instrument according to the elemental impurity testing method (e.g., optimize instrument conditions, set analysis parameters).
2. Introduce the sample into the ICP-MS instrument and run the analysis according to the method parameters.
3. Quantify elemental impurities using appropriate calibration standards and calculation methods.
4. Perform elemental impurity testing in duplicate or as per protocol requirements.

4.4 Acceptance Criteria

1. Ensure that the levels of elemental impurities 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 elemental 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
ICP-MS: Inductively Coupled Plasma Mass Spectrometry

6) Documents, if any

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

7) Reference, if any

Regulatory guidelines such as ICH Q3D Elemental Impurities, European Pharmacopoeia (Ph. Eur.) 2.4.20 Elemental Impurities

8) SOP Version

Version 1.0