Procedure for Endotoxin Testing in Injectable Products

1) Purpose

The purpose of this SOP is to outline the procedure for conducting endotoxin testing on injectable products to ensure compliance with regulatory requirements and patient safety.

2) Scope

This SOP applies to all injectable products manufactured within the facility that require endotoxin testing.

3) Responsibilities

Quality Control (QC) Department: Responsible for conducting endotoxin testing and ensuring compliance with this SOP.
Production Department: Responsible for providing samples and supporting QC during testing.

4) Procedure

4.1 Equipment Preparation:
    4.1.1 Set up the endotoxin testing system according to the manufacturer’s instructions.
    4.1.2 Ensure all equipment, including the endotoxin-specific reagents, is properly calibrated and verified.
    4.1.3 Prepare the standard endotoxin solutions as required for validation.

4.2 Sample Preparation:
    4.2.1 Obtain the injectable product samples from the production department.
    4.2.2 Dilute the samples appropriately if necessary, ensuring compatibility with the testing method.
    4.2.3 Handle samples aseptically to avoid contamination.

4.3 Endotoxin Testing Procedure:
    4.3.1 Perform the endotoxin testing according to the validated method (e.g., gel-clot, turbidimetric, chromogenic).
    4.3.2 Incubate the test samples with the endotoxin reagent under controlled conditions.
    4.3.3 Measure and record the reaction endpoint using appropriate instrumentation or visual assessment.
    4.3.4 Include appropriate positive and negative controls in