Content Uniformity Testing Procedures

1) Purpose

The purpose of this SOP is to outline the procedure for sampling capsules during filling and analyzing their content to ensure the consistent distribution of active ingredients.

2) Scope

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

3) Responsibilities

– QC personnel are responsible for conducting content uniformity tests on filled capsules.
– Production personnel must provide samples of filled capsules for testing.
– QA personnel are responsible for reviewing and approving the test 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. Sample Preparation
2.1. Carefully open the capsules and transfer the contents to a suitable container.
2.2. If necessary, dilute the samples according to the testing method requirements.
3. Analysis of Content Uniformity
3.1. Use an appropriate analytical method (e.g., HPLC, UV spectroscopy) to determine the concentration of active ingredients in each sample.
3.2. Follow the standard operating procedures for the chosen analytical method.
3.3. Calculate the uniformity by comparing the concentrations from different samples.
4. Acceptance Criteria
4.1. The content of active ingredients in each capsule should fall within the specified range (e.g., 85-115% of the label claim).
4.2. The relative standard deviation (RSD) of the active ingredient concentration should be within acceptable limits (e.g., RSD < 5%). 4.3. Any significant deviation from the expected uniformity may indicate issues with the filling process. 5. Documentation 5.1. Record all test results on the content uniformity test form. 5.2. Include details such as batch number, date of testing, analytical method used, and any observations or anomalies. 5.3. Sign and date the test form. 6. Review and Approval 6.1. Submit the completed test forms to the QA department for review. 6.2. QA will review and approve the results based on the criteria outlined in this SOP. 7. Corrective Actions 7.1. If the content uniformity does not meet the specified criteria, initiate a corrective action report. 7.2. Document all actions taken to address issues identified during the testing, including potential adjustments to the filling process.

5) Abbreviations, if any

– QC: Quality Control
– QA: Quality Assurance
– RSD: Relative Standard Deviation
– HPLC: High-Performance Liquid Chromatography

6) Documents, if any

– Content Uniformity Test 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