For the last two decades, regulatory expectations around extractables and leachables have continued to increase. While the focus had solely been on high-risk areas, like inhalation and parenteral drugs, these standards are now expected for nearly all dosage forms, manufacturing equipment and dosing devices. These widespread changes have understandably confused many organizations — but yours doesn’t need to be one of them.

With this expert advice, you’ll eliminate confusion around defining extractables and leachables and learn to determine which regulatory requirements apply. You will also discover how to effectively evaluate USP guidelines and industry standards, connecting them to various products along different points in the development cycle. Finally, you’ll be able to create a successful extractable and leachable program that will bring you closer to your goals while adhering to industry best practices.

Key webinar takeaways:

  • Basic extractable and leachable details
    1. The specifics of what constitutes an extractable or leachable
    2. Common confusions around these elements
  • Key regulatory requirements
    1. Evaluating USP guidelines and industry standards
    2. The increasing related regulations around extractables and leachables
    3. The differences in applying these standards to various products
    4. How regulations apply through the product development cycle
  • Developing extractable and leachable programs
    1. How to design an extractable and leachable program that meets your development goals and addresses regulatory requirements
    2. Best practices around an extractable and leachable program
    3. Recent trends regarding nitrosamines, elemental impurities and identifying unknowns
  • Common challenges
    1. Frequent analytical challenges associated with extractables and leachables
    2. Handling sensitivity requirements, product interferences and necessary testing

 

Regulatory requirements around extractables and leachables have been increasing and an effective program to identify these elements and meet these guidelines is essential. Don’t let the changes catch you off guard.

Who Will Benefit:

  • Drug companies
  • API suppliers
  • Excipient companies
  • Materials sourcing professionals
  • Supplier management professionals
  • Testing and in-bound materials teams
  • Quality assurance staff
  • Quality control staff
  • Regulatory affairs professionals
  • Manufacturing directors
  • Research and development teams
  • Submissions and approvals teams