Words Matter: A Commentary and Glossary of Definitions for Microbiological Quality
| Autor: | Gerald McDonnell, Hal Baseman, Lena Cordie-Bancroft |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Quality Control
Process management Glossary Computer Networks and Communications business.industry Biomedical Engineering Sterilization Pharmaceutical Science Microbiological quality Product (business) Sterilization (medicine) Risk analysis (engineering) Health care Commentary Equipment Contamination Product (category theory) Aseptic processing business |
| Zdroj: | Biomed Instrum Technol |
| ISSN: | 1948-2124 1079-7440 |
| DOI: | 10.5731/pdajpst.2021.012706 |
| Popis: | In the design, control, and regulation of the manufacturing and supply of microbiologically controlled devices (including sterile devices) and drug products (including cleaning, disinfection, and sterilization processing and/or aseptic process manufacturing), different terms and/or definitions are often used for similar processes or applications internationally. With product innovations (including combination products and cell-based therapy) and global regulatory influences, there is a growing need to harmonize these definitions. The objective of the Kilmer Regulatory Innovation microbiological quality and sterility assurance glossary is to clarify and harmonize the practical use of terms employed by the different parts of regulated healthcare product industries internationally and by regulators of the manufacturing and supply of microbiologically controlled healthcare products internationally. The glossary is expected to continue to evolve, and further industry, academic, and regulatory input is encouraged. |
| Databáze: | OpenAIRE |
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