Parenterals & Injectables

Biography

Biography: Edward Tidswell

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 legacy 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. Legacy 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 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 drug and device 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 core to an efficient system, coupled with recent learnings on global implementation.