Words Matter: A Commentary and Glossary of Definitions for Microbiological Quality

PDA J Pharm Sci Technol. 2021 Nov-Dec;75(6):553-570. doi: 10.5731/pdajpst.2021.012706.


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.

Keywords: Definitions; Glossary; Microbiological quality; Sterility assurance.

MeSH terms

  • Quality Control
  • Sterilization*