Standard Operating Procedure for Endotoxin Testing in Aseptic Creams
1) Purpose
The purpose of this SOP is to define procedures for conducting endotoxin testing on aseptic creams. This ensures that creams are free from harmful endotoxins that could compromise product safety and quality.
2) Scope
This SOP applies to the Quality Control Department and personnel responsible for conducting endotoxin testing of aseptic creams. It covers testing methods, acceptance criteria, documentation, and reporting requirements.
3) Responsibilities
The Quality Control Manager is responsible for overseeing endotoxin testing activities. The Quality Control Team and Testing Technicians are responsible for executing and ensuring compliance with this SOP.
4) Procedure
4.1 Sampling
4.1.1 Select representative samples of aseptic creams from the batch for endotoxin testing.
4.1.2 Ensure samples are taken aseptically and in accordance with sampling plans.
4.1.3 Label each sample with batch information and identification numbers.
4.2 Sample Preparation
4.2.1 Prepare cream samples for endotoxin testing under controlled and aseptic conditions.
4.2.2 Ensure samples are handled carefully to avoid contamination during preparation.
4.3 Testing Method
4.3.1 Select appropriate endotoxin testing method (e.g., Limulus Amebocyte Lysate (LAL) assay).
4.3.2 Validate the selected testing method according to established protocols and acceptance criteria.
4.4 Testing Procedure
4.4.1 Execute endotoxin testing according to validated methods and protocols.
4.4.2 Prepare samples and reagents
4.4.3 Incubate samples with LAL reagent and substrate under specified conditions.
4.4.4 Measure and record reactions to determine endotoxin concentration.
4.5 Acceptance Criteria
4.5.1 Establish acceptance criteria for endotoxin levels based on regulatory requirements and product specifications.
4.5.2 Compare test results against acceptance criteria to determine compliance with specified endotoxin limits.
4.6 Documentation and Reporting
4.6.1 Document all endotoxin testing activities, including sampling, preparation, testing methods, procedures, results, and observations.
4.6.2 Prepare endotoxin testing reports summarizing test conditions, results, conclusions, and recommendations.
4.6.3 Obtain approval from Quality Control Management for endotoxin testing reports.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
LAL: Limulus Amebocyte Lysate
6) Documents, if any
Endotoxin Testing Protocols
Endotoxin Testing Reports
Validation Reports for Testing Methods
7) Reference, if any
USP
Company-specific testing procedures for endotoxin testing
8) SOP Version
Version 1.0