Global implementation of system-based microbial control for parenteral manufacture
Edward C Tidswell
Baxter Healthcare Corporation, USA
: J Pharm Drug Deliv Res
Abstract
Parenteral manufacture has and always will experience microbiological risks in the provision of large quantities of safe therapies. This industry sector is facing acute regulatory, economic and legal challenges warranting a change in paradigm for the manufacture and microbial control of both large and small volume parenterals. Growing diversity of patient and therapeutic needs necessitates innovations in terms of marketed product and manufacturing processes. Legal infrastructure coupled with novel and changing manufactured products means that each facility will possess a unique risk profile. The relentless need to sustain and grow technical competency in tandem with expedient and exact manufacturing control demands that commensurate with risk profile is best served by ‘system-based microbial control’. System-based microbial control is a self-identifying and self-correcting process constructed from collective sub-systems, process controls, mechanisms which operate cohesively within an organization’s Quality Management System. System-based microbial control is the systematic and logic driven management process for the control of microbial hazards and risks during the drugs’ and devices’ manufacturing life-cycle assuring the provision of products meeting specifications. In a future in which manufacturing firms and regulatory agencies partner to focus on the provision of drugs and patient safety, an understanding of risk profiles, science and engineering-based logic and system-based control will be paramount. System-based microbial control within the frame work of a firm’s Quality Management System will be described with detailed examples of tools that are the core to an efficient system, coupled with recent learnings on global implementation.
Biography
Edward C Tidswell, BSc, PhD - Dr. Tidswell is a Quality Director for Baxter Healthcare; located north of Chicago, IL (USA). Within his role he supports more than 40 facilities setting strategy and tactical activities across the entire breadth of microbiological control, cleanroom control and sterility assurance. More specifically assuring process and product control through implementation of new systems-based process for sterile and aseptic manufacture for parenterals and medical devices. He has worked within bulk active pharmaceutical ingredient, vaccine and parenteral manufacturing operations for human health and animal health products in both technical and validation roles for the likes of Eli Lilly and Evans Vaccines. Dr Tidswell continues to actively publish and is a leading authority on risk, aseptic and sterile manufacture. In 2004 he received the Parenteral Society’s George Sykes Memorial Award for his contribution to pharmaceutical risk assessment. As a microbial physiologist Dr Tidswell retains an active interest in several areas of microbiology, which include: bacterial adhesion, quorum sensing, viability, anaerobes, and rapid microbial technologies. From 1995-2010 he has served on the Editorial Boards of Letters in Applied Microbiology and The Journal of Applied Microbiology. In June 2010 Dr Tidswell joined the USP expert committee on Microbiology & Sterility Assurance. In 2013 Dr Tidswell joined the PDA’s Science Advisory Board.
edward_tidswell@baxter.com
