Annex 1 - What the final draft reveals, and the impact on pharma

Stacey Bruzzese welcomes Dr. Tim Sandle, he is the head of microbiology and sterility assurance at Bio Products Laboratory Limited. Stacey and Alan have a conversation about the European GMP annex 1 and what the final draft reveals.

• What annex 1 actually is?
• What are the biggest changes from the previous version to the current document?
• What are some of the broad reaching impacts that annex 1 will have?
• What was lacking in previous versions, regarding contamination control?
• The distinction of viable counts and non-viable particle counts in this draft cause for concern.
• How will pharmaceutical companies produce the correct data based on the new verbiage in this document?
• How could this document affect the current processes in the lab?
• How will environment monitoring be changed moving forward?
• Will there be too many new steps for labs to monitor their clean rooms?
• Will we see more relaxed views on post sterilization integrity testing?
• Does Tim see this latest revision as an improved to the most recent draft?

Dr. Sandle is the Head of Microbiology and Sterility Assurance at Bio Products Laboratory Limited (a pharmaceutical organization). Dr. Sandle is a chartered biologist (Royal Society for Biology) and holds a first class honors degree in Applied Biology; a Masters degree in education; and obtained his doctorate from Keele University.

Dr. Sandle has over twenty-five years experience of designing and operating a range of microbiological tests (including sterility testing, endotoxin LAL methodlogy, microbial enumeration, environmental monitoring, particle counting, bioburden, isolators and water testing). In addition, Dr. Sandle is experienced in microbiological and quality batch review, microbiological investigation and policy development.