Regulatory and Testing Requirements of the Bacterial Endotoxin Testing (BET) or LAL Program

The Bacterial Endotoxin Test (BET) is an indispensable safety measure governed by the current good manufacturing practice (CGMP) regulations for pharmaceutical products and medical devices. A comprehensive understanding of this critical release assay, its implementation, and its significance in the production of cGMP goods is critical. It aids in reducing costly errors, batch disposals, expensive failure investigations, and delays in product release, all of which have plagued some manufacturers in the past.

This informative webinar is tailored to provide seasoned technicians with in-depth knowledge of how a Limulus Amebocyte Lysate (LAL) testing program can be leveraged for quality control to conform to regulatory requirements enforced by the FDA and EU.

The current requirements of the USP <85> Bacterial Endotoxin Test (BET) and European Pharmacopoeia (Chapter 2.6.14) will be discussed in this 60-minute webinar. It will address the different LAL testing methodologies and how to choose the best test method applicable to the product type. 

This webinar will outline the significance, regulatory, and testing requirements of products for compliance by applying the sequential steps in testing the product to rule out the presence of Endotoxins. Companies in the Pharmaceutical, Biotechnology, and Medical Device Industries that manufacture cGMP products requiring bacterial Endotoxin release assay will greatly benefit from this program.

This course is designed to introduce LAL methodologies to technicians who are new to LAL testing. Topics include:

• Endotoxins - What they are, where they come from, and why they are important
• LAL - An overview of the LAL/endotoxin reaction, with emphasis on sources of interference
• Detailed demonstration of the test methods including a discussion of laboratory set-up, materials, and aseptic techniques
• Specimen handling and preparation for the test
• Practical Approaches to specimen characterization
• Technician and laboratory certifications and protocols for validation of the LAL test

This course also provides the experienced technician with a more detailed understanding of how a LAL testing program can be applied to quality control.

• Introduction to current USP <85> Bacterial Endotoxin Test
• Types of Bacterial Endotoxin Test Methodologies
• Advantages and Disadvantages of Each Methodology and Choosing the Appropriate Method
• Initiating a Bacterial Endotoxin Test-Initial Considerations
• LAL Testing Materials and Reagent Qualification
• Products Receipt, Handling, and Storage
• Product Processing
• Handling, Investigating, and Resolving Failure and Out of Specification (OOS) Results
• Relationship of Endotoxin Test (LAL) with Other Production and Process Controls

• Quality Assurance Personnel
• Research and Development professionals
• Regulatory Affairs Personnel
• Quality Control Personnel
• Manufacturing professionals
• Engineering professionals
• Quality Engineers
• Compliance professionals
• Quality Auditors
• Microbiology Specialists