Keeping environmental monitoring relevant - fine tuning the programme

The revision to EU GMP Annex 1 calls for an environmental monitoring programme that is proactive, and risk based. The use of a simple ‘one size fits all’ approach to monitoring is no longer relevant.

Microbiologist and sterility expert Dr Tim Sandle joins RSSL Sterile Manufacture Lead Annette Russell to explore the elements you need to consider when fine tuning the environmental monitoring programme.

Topic areas we cover include:

• Contamination sources and vectors of contamination
• Linking environmental monitoring to change control
• Introducing risk based thinking to environmental monitoring sample selection and frequency determinations
• Going beyond the standards
• Linking monitoring to cleaning and disinfection
• Using rapid microbiological methods appropriately
• Connecting monitoring to facility maintenance
• Linking monitoring to shutdowns
• Tracking and trending microorganisms
• Setting appropriate limits

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.