Elstree, England, United Kingdom
Professor Tim Sandle is a pharmaceutical microbiologist. He is a consultant microbiologist, and professor at UCL and the University of Manchester as well as the Head of QA GxP Compliance, Sterility Assurance, and Quality Risk Management at Kedrion Biopharma (a pharmaceutical organization). Professor Sandle is a chartered biologist (Royal Society for Biology) and holds a first-class honours degree in Applied Biology (microbiology); a degree in political science; a Master's degree in HRM; and he obtained his doctorate from Keele University. Professor Sandle has over thirty years of experience in designing and operating a range of microbiological tests (including sterility testing, endotoxin LAL methodology, microbial enumeration, environmental monitoring, particle counting, bioburden, isolators and water testing). In addition, Professor Sandle is experienced in microbiological and quality batch review, microbiological investigation and policy development. Tim Sandle is an Associate Professor with UCL and a visiting tutor at the University of Manchester, both in relation to pharmaceutical microbiology and sterility assurance. Professor Sandle has, and currently, serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He was chair of the Pharmig LAL action group and has served on the Blood Service disinfection committee. He has written over nine hundred book chapters, peer reviewed papers and technical articles relating to microbiology, healthcare and pharmaceutical science; and delivered papers to over one hundred conferences. Professor Sandle is the editor of the Pharmaceutical Microbiology Interest Group Journal and the journal GMP Review. In addition, he runs an on-line microbiology website and forum (http://www.pharmamicroresources.com/). Professor Sandle is an experienced auditor and frequently acts as a consultant to the pharmaceutical and healthcare sectors. Specialities: Sterility testing; Bacterial Endotoxin Test; water systems; Microbial Limits Test; disinfectant selection and testing; viable and non-viable environmental monitoring; HVAC; cleanrooms; pharmaceutical water; sterilization; sterility assurance; isolation technology; auditing; Quality Assurance systems.
Associate Professor (Honorary) at the School of Pharmacy. Professor of Pharmaceutical Microbiology and Sterility Assurance.
Lecturer in pharmaceutical microbiology and sterilisation
Dr Tim Sandle is responsible for setting GxP standards, Sterility Assurance, and Quality Risk Management at BPL, in addition to acting as an internal pharmaceutical microbiology consultant. Duties include: Responsibility for the quality system. Quality risk management. Management of the: 1. Change control system. 2. Product Quality Review process. 3. Pest control. 4. QA oversight of training, including aseptic practices and sterility assurance. 5. Good Distribution Practice. 6. Quality Systems Improvement. 7. Quality strategy and projects. 8. Development of validation standards. 9. Pharmaceopeia review and implementation. 10. Receipt of external inspections and audits. 11. Sterility Assurance. 12. Contamination control. 13. Cleanroom design and standard setting. 14. Microbiology policy. Policy development. Continual improvement. Troubleshooting. Management of escalation and site quality council process. Development of KPIs relating to quality.
Pharmaceutical Microbiology Resources (PMR) - was created by Tim Sandle in December 2009. This is a website and consultation service. The website is operated as an independent and not-for-profit service for the pharmaceutical and healthcare sectors. The aim of this is to inform and discuss pharmaceutical microbiology (as relating to pharmaceuticals and healthcare), and related subjects (such as medical microbiology). The website offers a number of free resources and links to selected companies. Consultation and technical writing services are available (via Tim Sandle at: [email protected])
GMP is dedicated to informing, educating and supporting the healthcare industry by interpreting pharmaceutical regulations and related standards to keep organisations current. The journal educates organisations in current best GMP practices, technical, operational and strategic, to enable sound quality risk management and deliver business benefits. GMP Review challenges industry and regulators with leading edge concepts and approaches that enable organisations to build a mature governance culture.
Journalist at Digital Journal since 2011. Promoted to Editor at Large for Science in 2015. Digital Journal is a global digital media network.