Standard Operating Procedure for Residual Solvent Testing

1) Purpose

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

2) Scope

This SOP applies to residual solvent 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 residual solvent 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 residual solvent testing protocol and ensure all necessary materials and equipment are available (e.g., gas chromatograph, standards for calibration).
2. Verify the calibration and functionality of the gas chromatograph.

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 dissolving or diluting according to the residual solvent testing method.

4.3 Testing Procedure

1. Prepare the gas chromatograph according to the residual solvent testing method (e.g., column selection, detector settings).
2. Inject the sample into the gas chromatograph and run the analysis according to the method parameters.
3. Quantify residual solvents using appropriate calibration standards and calculation methods.
4. Perform residual solvent testing in duplicate or as per protocol requirements.

4.4 Acceptance Criteria

1. Ensure that the levels of residual solvents 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 a residual solvent 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

Residual Solvent Testing Protocol, Testing Records, Testing Reports, Sample Collection and Preparation Records

7) Reference, if any

Regulatory guidelines such as USP <467> Residual Solvents, European Pharmacopoeia (Ph. Eur.) 2.4.24 Residual Solvents

8) SOP Version

Version 1.0