Course Overview

The course begins with an overview of Annex 1 within the current regulatory landscape, highlighting the most significant updates and their impact on sterile manufacturing operations.

A key feature of the programme is the hands-on experience in NIBRT’s pilot plant facilities. Participants will gain valuable practical insights through direct exposure to NIBRT’s advanced fill-finish manufacturing line, exploring how Annex 1 requirements are implemented in a real-world production environment.

Special focus will be placed on:

• Pre-Use Post-Sterilisation Integrity Testing (PUPSIT) – implementation, regulatory expectations, and operational challenges
• Environmental monitoring strategies within Grade A, B, and C cleanroom environments for fill-finish operations
• Practical application of Annex 1 principles throughout drug product manufacturing processes

Key Learning Outcomes

By attending this programme, participants will:

• Understand the latest Annex 1 updates and their implications for sterile manufacturing
• Learn the principles, benefits, and challenges associated with PUPSIT
• Explore best practices for environmental monitoring in fill-finish facilities
• Gain practical knowledge of applying Annex 1 requirements across drug product manufacturing operations

Who Should Attend?

This programme is designed for professionals working in biopharmaceutical and pharmaceutical manufacturing who require an understanding of Annex 1 updates and their operational impact. It is particularly relevant for manufacturing personnel, quality professionals, operations teams, and organisations seeking to enhance compliance and operational readiness.

Certification

Participants who successfully attend the programme will receive a Certificate of Attendance.