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This week, Stacey is joined by Dr. Tim Sandle to discuss developing effective contamination control strategies to deal with all aspects of contamination such as particulate, microbial, product carryover, chemical (like cleaning material residues) as well as viral. Dr. Tim Sandle details the common types of contamination, what regulators are seeking from control strategies, the challenges of implementing control strategies, and much more.
Resources for this Episode:
Biocontamination Control for Pharmaceuticals and Healthcare, by Tim Sandle
EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products (Draft)
ISO 14698-1: 2003, Cleanrooms and associated controlled environments
FDA Guidelines on Contamination Control
Sterile Drug Products Produced by Aseptic Processing
〈797〉 Pharmaceutical Compounding—Sterile ... - USP
About Our Guest:
Dr. Tim Sandle Ph.D. is a pharmaceutical microbiologist, with over 25 years of experience, who has worked for different healthcare organizations and pharmaceutical companies, in microbiology and broader quality roles. Dr. Sandle currently works for an international sterile products manufacturer and he is additionally a visiting tutor with the University of Manchester (lecturing in pharmaceutical microbiology), a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig), and a supporter of several other societies relating to pharmaceuticals and healthcare, including IVT. Dr. Sandle also serves on several advisory committees and standards boards. Dr. Sandle has written or edited over 25 books, more than 100 book chapters, 125 peer-reviewed papers, and some 400 technical articles. Dr. Sandle is a regular presenter at conferences and webinars, having delivered over 150 presentations.
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