Scope

This comprehensive training program is based on the EU GMP Guidelines (EudraLex, Volume 4) and is designed to provide pharmaceutical and biotechnology manufacturing personnel with a thorough understanding of Good Manufacturing Practice principles, requirements, and practical applications. The training covers Part I: Basic Requirements for Medicinal Products, along with key annexes relevant to sterile products, biological products, and radiopharmaceuticals. The goal is to ensure that all personnel are equipped to maintain compliance, ensure product quality, and uphold patient safety throughout the manufacturing lifecycle.

Training Objectives

• Understand the structure and legal basis of the EU GMP Guide
• Apply GMP principles in daily operations
• Identify and mitigate risks to product quality
• Comply with documentation, production, and quality control requirements
• Recognize the importance of personnel hygiene, premises, and equipment in GMP
• Implement corrective and preventive actions (CAPA) effectively