FDA's New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices

Duration: 90 Minutes
The current thinking of the FDA regarding the use of the Limulus Amoebycyte Lysate (LAL) test for endotoxins in lieu of the rabbit pyrogens test has changed. As a result, the last guidance document, Guideline on Validation of the Limulus Amedocyte Lysate (LAL) Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices, which was published in 1987, has been withdrawn by the agency.
New Endotoxin Test Guidance
Instructor: Angela K. Dunston
Product ID: 501050

The FDA has found that the published USP and AAMI documents describing methods and calculation of pyrogen and endotoxins testing limits provide industry with appropriate information. There are continuing efforts to harmonize USP Chapters <85> and <161> and FDA guidance documents to reflect the current thinking of the agency. Until this harmonization is complete, the FDA is providing supplemental information in this guidance to explain the current thinking regarding submission and maintenance of pyrogen and endotoxins testing for FDA regulated products.

Areas Covered
  • Background
  • Definitions
  • Examine the 1987 guidance for industry document
  • Review current testing requirements
  • Overview of new guidance for industry LAL
  • Examine the bases for Bacterial Endotoxin Tests
  • Learn of the documents supporting the proposed, new FDA Guidance
  • Learn which specific Chapter is yet to be harmonized
  • Learn the typical issues confronting the end user of LAL testing
  • Warning Letter examples

Why Should you Attend
This guidance does not cover the entire subject of pyrogen and endotoxins testing. Instead, it addresses those issues that may be subject to misinterpretation and are not covered in compendial procedures or in currently available documents. There should already be a thorough understanding of these compendial references. The recommendations should be incorporated by organization in order to adopt the current thinking of the agency to prevent observations.

Objectives of the Presentation
  • Provide a review of the current testing requirements
  • Understanding what happened to the old 87/91 LAL Guidance for industry document
  • Learn what has replaced it and why
  • Learn common issues, misunderstandings and misinterpretations
  • Determine who comprised the agency guidance team involved with in this new proposed Guidance
  • Learn the documents supporting this new Guidance
  • Learn about sampling, storage, handling and pooling
  • How does one transition from one bacterial endotoxin test to another—understand the RPT (Rabbit Pyrogen Test)
  • Learn about the Monocyte Activation Test (MAT). Determine when the Rabbit Pyrogen Test is appropriate to use in lieu of the LAL
  • Understand the FDA's expectation for screening of therapeutic products.
Who can Benefit
  • Senior Management
  • Regulatory Affairs Management and Personnel
  • Compliance Officer and Personnel
  • Quality Assurance Management and Personnel
  • Research and Development
  • Validation
  • Auditing Management and Professional
  • Quality Control Management and Professional
$375
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Instructor Profile:
Angela K. Dunston has over 20 years of experience in manufacturing and laboratory quality and compliance in the pharmaceutical, biotechnology, and medical device (diagnostics) industries. Her expertise is in defining, implementing, and maintaining Quality Management Systems that are cohesive and properly interact with all areas of the organization.

During these 20 years, Angela has actively participated in global regulatory inspections to include US FDA in the capacity of host, SME, and scribe. Through consulting with a variety of companies, Angela has worked with US FDA agents to ensure compliance for her clients.

The international experience obtained has assisted global organizations such as Johnson and Johnson, the Croda Corporation, Novartis, Hospira, Sanofi Pasteur, and Quintiles to exceed regulatory expectations. She has authored company best practices manuals and has trained on those procedures from the V-suite to the manufacturing floor. Angela works closely with the company’s staff to ensure a cohesive transition for non-compliance to policy approval.
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