Extractables and Leachables Requirements in Pharmaceutical Development

Tuesday, November 12 2013
8:00 am – 5:00 pm

This event was posted by NSF Pharmalytica Services

Location: NSF-DBA Boston Office - 129 South Street, Boston MA 02111

This course will provide an overview of E&L with regard to pharmaceutical packaging/container closure systems, processing equipment and devices for drug products including biologics. We will review the regulatory framework and explain why this area is getting so much attention. You will learn about material selection and the risks certain materials present from an E&L standpoint. You will also gain insight into the best practices for E&L testing.

The PQRI Working Group best practices for ‘Orally Inhaled and Nasal Drug Products’ was published in 2006. A similar process is being conducted by PQRI for ‘Parenteral and Ophthalmic Drug Products’ and preliminary approaches were presented in an open forum in February 2011. The course will compare and contrast elements of these best practices.

E&L studies generally apply to the selection of components and evaluating changes in components or in their use. This course will also illustrate the importance of routine E&L control.

The course format will be lecture and casework to involve the participants in tackling real E&L issues and discussing solutions.

The course will be of value to development scientists, development engineers, validation scientists, quality control analysts and individuals with quality control and quality assurance responsibilities. Suppliers of components for device manufacturers and disposable biological systems will gain valuable insight. Both N1 and N2 suppliers will benefit. Anyone with E&L project oversight and questions on best practices will benefit by attending this course.

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