Allen E Goldenthal

Managing Quality In Biotechnology Allen E Goldenthal

Managing Quality in Biotechnology is unique in its approach to Total Quality Management (TQM) as it adopts an insider's view of what is crucial and important in the day-to-day operations of bio-related laboratories at both an academic research level as well as by a full production facility. Most reference books on TQM have been written specifically for the commercial production facility and have not addressed that quality must begin at inception of the initial concept and that relies on it being implemented all the way back to the primary investigator in his university or company laboratory. Though the research laboratory operates at a much smaller scale and modality, still all the essential requirements and expectations of TQM and Good Manufacturing Practices (GMP) apply. Ensuring that initial research and development meets the expectations of safety, efficacy and potency is why TQM is probably even more important within academic institutions. The absence of guidelines being applied to the university and developmental laboratory environments makes this book an essential part of any research library. It is a comprehensive reference book for university students, a hands-on manual for laboratory technicians, and a practical guide for biopharmaceutical managers.