Standard Operating Procedure for pH Testing

1) Purpose

The purpose of this SOP is to establish a standardized procedure for performing pH testing on pharmaceutical products to ensure they meet quality standards and regulatory requirements.

2) Scope

This SOP applies to all pharmaceutical products that require pH testing within the facility, including solutions, suspensions, and other liquid forms.

3) Responsibilities

3.1 Laboratory Analyst
– Conduct pH tests as per this SOP.
– Document and report test results accurately.
3.2 Laboratory Supervisor
– Ensure all testing procedures are followed.
– Review and approve pH test records.
3.3 Quality Assurance (QA) Personnel
– Validate pH testing methods.
– Ensure compliance with regulatory guidelines.

4) Procedure

4.1 Preparation
4.1.1 Clean and disinfect the testing area and equipment.
4.1.2 Prepare the pH meter and calibrate it using standard buffer solutions.
4.2 Sampling
4.2.1 Collect samples aseptically to prevent contamination.
4.2.2 Transport samples to the testing area in appropriate containers.
4.3 Testing Methods
4.3.1 Immerse the pH electrode in the sample and allow the reading to stabilize.
4.3.2 Record the pH value, ensuring the pH meter is properly calibrated and functioning.
4.4 Monitoring and Documentation
4.4.1 Monitor the pH meter’s performance regularly and recalibrate as needed.
4.4.2 Record observations and test results in the pH Test Log.
4.5 Reporting
4.5.1 Compile test results and prepare a pH test report.
4.5.2 Submit the report to QA for review and approval.
4.6 Investigation of Failures
4.6.1 Investigate any deviations from acceptable pH ranges to determine the cause.
4.6.2 Implement corrective actions to prevent recurrence.

5) Abbreviations, if any

– QA: Quality Assurance

6) Documents, if any

– pH Test Log
– pH Test Reports
– Calibration Records

7) Reference, if any

– United States Pharmacopeia (USP) General Chapter <791> pH
– European Pharmacopoeia (Ph. Eur.) 2.2.3 Potentiometric Determination of pH

8) SOP Version

Version 1.0