Procedures for Weighing Filled Capsules

1) Purpose

The purpose of this SOP is to establish a standardized procedure for regularly weighing filled capsules to verify that the dosage meets specified requirements and to ensure weight uniformity.

2) Scope

This SOP applies to all filled capsules produced within the pharmaceutical manufacturing facility.

3) Responsibilities

– QC personnel are responsible for conducting the weight checks on filled capsules.
– Production personnel must provide samples of filled capsules for testing.
– QA personnel are responsible for reviewing and approving the weight check results.

4) Procedure

1. Sample Collection
1.1. Collect a representative sample of filled capsules from each batch.
1.2. Ensure samples are collected at regular intervals during the filling process.
1.3. Label each sample with batch number, date, and time of collection.
2. Weighing Capsules
2.1. Ensure that the balance is calibrated according to the manufacturer’s instructions.
2.2. Place the balance on a stable, vibration-free surface.
2.3. Tare the balance to zero before weighing capsules.
2.4. Weigh each capsule individually and record the weight.
2.5. Calculate the average weight, standard deviation, and relative standard deviation (RSD) of the sample.
3. Acceptance Criteria
3.1. Verify that the average weight of the capsules falls within the specified range.
3.2. Ensure that the RSD of the sample is within acceptable limits (e.g., RSD < 5%). 3.3. Any significant deviation from the expected weight range may indicate issues with the filling process. 4. Documentation 4.1. Record all weight check results on the capsule weight check form. 4.2. Include details such as batch number, date of testing, balance calibration status, and any observations or anomalies. 4.3. Sign and date the weight check form. 5. Review and Approval 5.1. Submit the completed weight check forms to the QA department for review. 5.2. QA will review and approve the results based on the criteria outlined in this SOP. 6. Corrective Actions 6.1. If the capsule weights do not meet the specified criteria, initiate a corrective action report. 6.2. Document all actions taken to address issues identified during the weight checks, including potential adjustments to the filling process.

5) Abbreviations, if any

– QC: Quality Control
– QA: Quality Assurance
– RSD: Relative Standard Deviation

6) Documents, if any

– Capsule Weight Check Form
– Corrective Action Report Form

7) Reference, if any

– FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
– USP <905> Uniformity of Dosage Units

8) SOP Version

Version 1.0