Purpose

The purpose of this SOP is to outline the procedures for conducting pH testing during the tablet/ capsule manufacturing process to ensure the acidity or alkalinity of the tablets / capsule.

Scope

This SOP applies to all personnel involved in tablet manufacturing, specifically those responsible for pH testing.

Responsibilities

• Quality Control Analysts: Conducting pH testing according to this SOP.
• Production Department: Providing samples for testing and cooperating with quality control personnel.
• Quality Assurance Department: Ensuring compliance with regulatory standards and guidelines.

Procedure

1. Calibrate the pH meter using standard buffer solutions.
2. Take the tablet/ capsule sample and prepare a solution according to defined procedures.
3. Immerse the pH electrode into the capsule / tablet solution and allow time for stabilization.
4. Record the pH value displayed on the pH meter.
5. Repeat the process for each capsule/ tablet sample as per the testing plan.
6. Compare the pH values against acceptance criteria.
7. Document all testing procedures, observations, and results accurately and comprehensively.
8. Review and approve the test results by authorized personnel.
9. Initiate corrective actions if deviations from acceptance criteria are identified.

Abbreviations Used

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

Documents

• pH Testing Protocol
• Standard Operating Procedures Manual
• Batch Records
• Quality Control Reports
• Deviation Reports

Reference

No specific references are cited for this SOP.

SOP Version

Version 1.0