Standard Operating Procedure for Disintegration Testing

1) Purpose

This SOP outlines the procedures for conducting disintegration testing on pharmaceutical solid oral dosage forms to assess their disintegration characteristics.

2) Scope

This SOP applies to disintegration testing of tablets and capsules manufactured in the pharmaceutical facility.

3) Responsibilities

The Quality Control (QC) department is responsible for performing disintegration 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 disintegration testing protocol and ensure all necessary materials and equipment are available (e.g., disintegration apparatus).
2. Verify the calibration and functionality of the disintegration apparatus.

4.2 Sample Collection and Preparation

1. Collect a representative sample of solid oral dosage forms according to sampling procedures.
2. Ensure proper labeling and identification of samples.

4.3 Testing Procedure

1. Place one dosage unit into each tube of the disintegration apparatus.
2. Add the specified disintegration medium to each tube.
3. Operate the disintegration apparatus under the specified conditions (e.g., temperature, rotation speed).
4. Observe each unit for complete disintegration according to the defined disintegration time.

4.4 Acceptance Criteria

1. Ensure that all units disintegrate completely within the specified time period.
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 disintegration 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

Disintegration Testing Protocol, Testing Records, Testing Reports, Sample Collection and Preparation Records

7) Reference, if any

Regulatory guidelines such as USP <701> Disintegration, European Pharmacopoeia (Ph. Eur.) 2.9.1 Disintegration of Tablets and Capsules

8) SOP Version

Version 1.0