PT  - JOURNAL ARTICLE
AU  - Gerald McDonnell
AU  - Hal Baseman
AU  - Lena Cordie-Bancroft
TI  - Words Matter: A Commentary and Glossary of Definitions for Microbiological Quality
AID  - 10.5731/pdajpst.2021.012706
DP  - 2021 Nov 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 553--570
VI  - 75
IP  - 6
4099  - http://journal.pda.org/content/75/6/553.short
4100  - http://journal.pda.org/content/75/6/553.full
SO  - PDA J Pharm Sci Technol2021 Nov 01; 75
AB  - 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 internationally for similar processes or applications. 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 health care product industries internationally and by regulators of the manufacturing and supply of microbiologically controlled health care products internationally. The glossary is expected to continue to evolve; and further industry, academic, and regulatory input is encouraged.