EU GMP Annex 1 - the focal points

We will delve into the aspects that all manufacturers need to consider to remain compliant, including quality risk management, contamination strategy, cleanroom certification and water systems.

Learning outcomes:

• Understand the major updates to EU GMP Annex 1 and how they differ to the current guidance
• Learn how the key changes will impact the control and release of sterile products
• Gain an insight into the elements required for a contamination control strategy
• Become familiar with the importance of quality risk management in relation to sterile products
• Consider those areas that regulators are likely to put the greatest emphasis upon

Dr. Tim Sandle has over twenty-five years’ experience of microbiological research and biopharmaceutical processing. He is a member of several editorial boards and he has written over six hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle works for a pharmaceutical manufacturer in the UK, and is a visiting tutor at both the University of Manchester and UCL.