Standard Operating Procedure for Endotoxin Testing in Aseptic Gels
1) Purpose
The purpose of this SOP is to establish procedures for detecting and quantifying endotoxin levels in aseptic gels to ensure product safety and compliance.
2) Scope
This SOP applies to the Quality Control (QC) department responsible for performing endotoxin testing on aseptic gels manufactured at the pharmaceutical manufacturing facility.
3) Responsibilities
Quality Control (QC): Perform endotoxin testing according to defined procedures and standards.
Quality Assurance (QA): Oversee the implementation of endotoxin testing procedures and ensure compliance with SOPs and regulatory guidelines.
Microbiology Laboratory: Provide technical support and expertise in endotoxin testing methods and analysis.
4) Procedure
4.1 Sample Collection and Preparation
4.1.1 Collect representative samples from finished aseptic gel batches with documented batch/lot numbers and production records.
4.1.2 Ensure samples are handled aseptically and stored appropriately prior to testing.
4.2 Endotoxin Extraction
4.2.1 Extract endotoxins from the gel samples using validated extraction methods.
4.2.2 Ensure extraction conditions are suitable for efficient recovery of endotoxins from the gel matrix.
4.3 Endotoxin Assay
4.3.1 Prepare endotoxin assay reagents and standards according to manufacturer instructions.
4.3.2 Perform endotoxin assay using appropriate techniques such as turbidimetric, chromogenic, or gel clot methods.
4.3.3 Ensure assay conditions are controlled to minimize interference and ensure accurate results.
4.4 Calculation and Interpretation of Results
4.4.1 Calculate endotoxin levels in the samples based on standard curves or quantitative methods.
4.4.2 Compare endotoxin levels against acceptance criteria specified in pharmacopoeial monographs or company specifications.
4.5 Compliance Assessment
4.5.1 Evaluate endotoxin test results for compliance with established limits for aseptic gels.
4.5.2 Document compliance or non-compliance with endotoxin specifications.
4.6 Reporting and Documentation
4.6.1 Prepare detailed test reports documenting endotoxin test results, compliance status, and any deviations.
4.6.2 Maintain accurate records of all endotoxin testing activities, including protocols, data sheets, and reports.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
– Endotoxin Testing Protocols and Procedures
– Extraction and Assay Records
– Test Reports and Data Sheets
7) Reference, if any
– Pharmacopoeial monographs (e.g., USP, Ph. Eur.) on endotoxin testing requirements
– Company-specific endotoxin testing guidelines
8) SOP Version
Version 1.0