Standard Operating Procedure for Weight Variation Testing

1) Purpose

This SOP outlines the procedures for conducting weight variation testing on solid oral dosage forms to ensure uniformity and compliance with dosage specifications.

2) Scope

This SOP applies to weight variation testing of solid oral dosage forms such as tablets and capsules manufactured in the pharmaceutical facility.

3) Responsibilities

The Quality Control (QC) department is responsible for performing weight variation 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 weight variation testing protocol and ensure all necessary materials and equipment are available (e.g., analytical balance, sample divider).
2. Verify the calibration and accuracy of the analytical balance.

4.2 Sample Collection and Preparation

1. Collect a representative sample of solid oral dosage forms according to sampling procedures.
2. Prepare individual units for testing by removing excess powder or granules (if applicable).
3. Use a sample divider to obtain the required number of units for testing.

4.3 Testing Procedure

1. Weigh each individual unit using the calibrated analytical balance.
2. Record the weight of each unit and calculate the average weight and percent deviation from the average.
3. Compare individual unit weights against the acceptance criteria specified in compendial standards or product specifications.

4.4 Acceptance Criteria

1. Ensure that the individual unit weights fall within the specified range or percentage deviation from the average weight.
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 weight variation 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

Weight Variation Testing Protocol, Testing Records, Testing Reports, Sample Collection and Preparation Records

7) Reference, if any

Regulatory guidelines such as USP <905> Uniformity of Dosage Units, USP <1174> Powder Flow, European Pharmacopoeia (Ph. Eur.) 2.9.5 Uniformity of Mass of Single-Dose Preparations

8) SOP Version

Version 1.0