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 each test run.
4.4 Calculation and Interpretation:
4.4.1 Calculate the endotoxin concentration in the samples based on the standard curve or reference preparation.
4.4.2 Compare the measured endotoxin levels against acceptance criteria specified in pharmacopeial standards or internal specifications.
4.4.3 Document and investigate any deviations from expected results, taking corrective actions as necessary.
4.5 Acceptance Criteria:
4.5.1 Endotoxin levels in injectable products should not exceed the specified limits for safe administration.
4.5.2 Ensure that all controls demonstrate appropriate responses within established limits.
4.6 Documentation:
4.6.1 Record all endotoxin testing results, including method validation data, in the Endotoxin Testing Record.
4.6.2 Maintain accurate records of sample preparation, testing conditions, and any deviations encountered.
4.6.3 Review and approve the documentation by QC Manager.
5) Abbreviations, if any
QC: Quality Control
6) Documents, if any
Endotoxin Testing Record
Method Validation Report for Endotoxin Testing
Sampling Plan Document
7) Reference, if any
USP General Chapter <85> – Bacterial Endotoxins Test
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
8) SOP Version
Version 1.0