Uniformity Testing for Mixing and Blending

1) Purpose

The purpose of this SOP is to establish a standardized procedure for sampling and analyzing blended or mixed products to confirm the uniform distribution of ingredients, ensuring consistent quality and efficacy of pharmaceutical products.

2) Scope

This SOP applies to all mixing and blending operations performed within the pharmaceutical manufacturing facility.

3) Responsibilities

– QC personnel are responsible for conducting uniformity tests on blended or mixed products.
– Production personnel must provide samples from different stages of the mixing or blending process.
– QA personnel are responsible for reviewing and approving the test results.

4) Procedure

1. Sample Collection
1.1. Collect representative samples from different locations within the blender or mixer.
1.2. Ensure samples are taken from the top, middle, and bottom sections to capture potential variability.
1.3. Label each sample with batch number, sample point, and date.
2. Sample Preparation
2.1. Homogenize each sample to ensure consistency before analysis.
2.2. If necessary, dilute the samples according to the testing method requirements.
3. Analysis of 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 relative standard deviation (RSD) of the active ingredient concentration should be within the specified limits (e.g., RSD < 5%). 4.2. Any significant deviation from the expected uniformity may indicate inadequate mixing or blending. 5. Documentation 5.1. Record all test results on the mixing and blending 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 blend does not meet the uniformity criteria, initiate a corrective action report. 7.2. Document all actions taken to address issues identified during the testing, including potential re-blending or remixing.

5) Abbreviations, if any

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

6) Documents, if any

– Mixing and Blending Uniformity Test Form
– Corrective Action Report Form

7) Reference, if any

– FDA Guidance for Industry: Q2(R1) Validation of Analytical Procedures
– USP <905> Uniformity of Dosage Units

8) SOP Version

Version 1.0