The contamination control strategy – putting the jigsaw together

Designing a contamination control strategy is central to the revision to EU GMP Annex 1. But how should this be approached? During this webinar, we explore the elements you need to consider when building a contamination control strategy. This includes designing a strategy that is holistic, interlined, and relevant.

A contamination control strategy is a system that considers all the integral elements of pharmaceutical product manufacturing. This is best achieved using quality risk management principles and supporting risk assessments for contamination control and monitoring (detectability of contamination event). This webinar presents the fundamentals of such a strategy.

Topic areas we cover include:

• Microbial contamination
• Cleaning and disinfection
• Sterility assurance
• Facility design
• Chemical and particle contamination
• Other forms of contamination that can arise from mix-ups, damaging primary or secondary packaging, distribution problems, and environmental fluctuations

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.