GMP Requirements and Challenges for RTU/RTS Material

Objectives

Which requirements apply for GMP pre-sterilized packaging material and single-use-systems (e.g., ready-to-use (RTU), ready-to-sterilize (RTS) products)? During this conference, you will hear about all aspects of the GMP manufacture of pre-sterilized products (e.g., vials, stoppers) that influence the quality of the final product. In addition, practice-oriented presentations and case studies will guide you through the relevant requirements on qualification / validation, and controls for pre-sterilized materials, including impact of the revised EU GMP Annex 1.

Registration

Background

Currently there is a growing demand in the development of pre-sterilized packaging materials and single-use-systems (SUS) for several enhanced Biotech applications. However, new GMP requirements for the sterile packaging material (e.g. regarding validation of the sterilization procedure) apply with the revised EU GMP Annex 1 entitled “Manufacture of Sterile Medicinal Products”, which provides guidance on the approaches to sterilization of products, equipment and packaging components. All sterilization processes should be validated.

This event will therefore deal with the current discussions and trends in the manufacture of RTU/RTS material:

• GMP requirements for sterilization of packaging materials / devices / SUS
• Selection of a suitable sterilization method
• Critical process parameters (CPPs) that should be considered in qualification and / or routine processing
• Validation strategy
• Requirements for suppliers

The presentations will be provided in a practice-oriented way from the different viewpoints of authorities, suppliers of packaging materials / devices / services (including sterilization activities), and the pharmaceutical industry.