What to Expect From the New EU GMP Annex 1

Duration: 60 Minutes
What to expect from the new Annex 1? The global contamination control standard for sterile products is now on its 10th version and it is expected to appear during 2020. The focus will be with key things to prepare for and the new topics that will drive the new Annex, including the need for a contamination control strategy and the key aspects of quality risk management. The presentation also covers personnel training, equipment qualification, cleanroom design and environmental monitoring.
New EU GMP Annex 1
Instructor: Tim Sandle
Product ID: 503828
Objectives of the Presentation
  • Contamination control strategy
  • Quality systems
  • Cleanrooms
  • Disinfection
  • Personnel
  • Aseptic processing
  • And moreā€¦
Why Should you Attend
Learn about the forthcoming standard governing the manufacture of sterile products, and the special requirements to minimize the risks of microbiological, particulate and pyrogen contamination of sterile products. The main objective is to signal the changes and provide advice on what to expect and what to prepare for.

Areas Covered
  • Cleanroom design
  • Contamination control strategy
  • Filter testing / PUPSIT
  • Cleaning and disinfection
  • Staff training
  • Engineering principles
  • Good aseptic processing
  • Terminal sterilization
  • Batch release process
Who will Benefit
  • Quality Assurance
  • Quality Control
  • Microbiologists
  • Sterility assurance professionals
  • Production managers
  • Pharmaceutical Engineers
  • Academics
Topic Background
Annex 1 covers the manufacture of sterile pharmaceutical products (and there are points that apply to non-sterile products are well). The standard is undergoing its most extensive revision for over 15 years. What can we expect from this new standard? Collecting information from conference, draft versions and from discussions with regulators, Tim Sandle sign-posts the direction that the standard is likely to take and provides guidance on what needs to be prepared.
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Instructor Profile:
Dr. Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing. He is Head of Microbiology at Bio Products Laboratory (U.K.) and a visiting tutor with The University of Manchester School of Pharmacy. Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control. He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); and is a member of several editorials boards for scientific journals.

Dr. Sandle has written over three hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle's current research interests are cleanroom fungi; microbiology of water; disinfectants; and rapid microbiological methods.

In addition, Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); serves on the National Blood Service advisory cleaning and disinfection committee; and is a member of eleven editorials boards for scientific journals.

Dr. Sandle has acted as a consultant, expert witness and technical advisor to sterile and non-sterile manufacturing facilities, microbiology laboratories, the medical device industry and hospitals. Dr. Sandle has also undertaken several technical writing and review projects.
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