Standard Operating Procedure for Friability Testing of Tablets

1) Purpose

This SOP outlines the procedures for conducting friability testing on pharmaceutical tablets to assess their resistance to abrasion and impact.

2) Scope

This SOP applies to friability testing of tablets manufactured in the pharmaceutical facility.

3) Responsibilities

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

4.2 Sample Collection and Preparation

1. Collect a representative sample of tablets according to sampling procedures.
2. Ensure proper labeling and identification of samples.

4.3 Testing Procedure

1. Weigh the tablets and place them in the friability tester.
2. Operate the friability tester under specified conditions (e.g., number of rotations, duration).
3. After testing, remove the tablets, brush off any loose dust, and reweigh.
4. Calculate the percentage friability using the formula:
   ( text{Friability (%)} = left( frac{{text{Initial weight – Final weight}}}{{text{Initial weight}}} right) times 100 )

4.4 Acceptance Criteria

1. Ensure that the percentage friability of the tested tablets meets the specified acceptance criteria.
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 friability 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

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

7) Reference, if any

Regulatory guidelines such as USP <1216> Tablet Friability, European Pharmacopoeia (Ph. Eur.) 2.9.7 Friability of Uncoated Tablets

8) SOP Version

Version 1.0