GMP for Prefilled Syringes

Objectives

In this course you will learn which requirements for pre-fillable syringes are defined by the regulations. You get to know all aspects of the manufacture of pre-fillable syringes that influence the filling process and the quality of the final product. In addition, practice-oriented case studies will guide you through the relevant production processes, simulations and controls for pre-filled syringes.

Registration

Background

Currently there is a growing demand in the development of pre-fillable syringes (e.g. ready-to-fill, ready-to-use, sterile clean filling) for several enhanced Biotech applications (i.e. for the final product, the Pre-filled Syringe). However, new GMP requirements, also for the sterile packaging material (e.g. regarding validation of the sterilization procedure for the syringe), apply with the EU GMP Annex 1 entitled “Manufacture of Sterile Medicinal Products”.

This event will therefore deal with the current discussions and trends in the manufacture of pre-filled syringes:

• GMP requirements for pre-fillable syringes / devices
• PFS Design & Safety Systems
• Alternatives to glass
• GMP Requirements for personnel, cleanrooms, equipment & facilities
• Processing of pre-filled syringes
• Auto-injector Assembling
• Contamination Control Strategy
• Observations during GMP inspections

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.

Target Audience

This event is designed for employees working in the pharmaceutical industry (including drug device combination products), for suppliers of packaging materials & devices and to all who have to deal with the manufacture, control and release of prefilled syringes. They key areas are

• Sterile Production
• Packaging material / Device development
• Manufacturing / Processing / Assembling
• Quality Control
• Quality Assurance