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Annex 1 - What the final draft reveals, and the impact to pharma.
Stacey Bruzzese welcomes Dr. Tim Sandle, he is the head of microbiology and sterility assurance at Bio Products Laboratory Limited. Stacey and Tim have a conversation about the European GMP annex 1 and what the final draft reveals.
- What annex 1 actually is?
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.
Dr. Sandle is the editor of the Pharmaceutical Microbiology Interest Group Journal and runs an on-line microbiology website and forum (http://www.pharmamicroresources.com/). Dr. Sandle is an experienced auditor and frequently acts as a consultant to the pharmaceutical and healthcare sectors.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
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By IVT NetworkStacey Bruzzese welcomes Dr. Tim Sandle, he is the head of microbiology and sterility assurance at Bio Products Laboratory Limited. Stacey and Tim have a conversation about the European GMP annex 1 and what the final draft reveals.
- What annex 1 actually is?
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.
Dr. Sandle is the editor of the Pharmaceutical Microbiology Interest Group Journal and runs an on-line microbiology website and forum (http://www.pharmamicroresources.com/). Dr. Sandle is an experienced auditor and frequently acts as a consultant to the pharmaceutical and healthcare sectors.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.