A set of conditions encompassing upper and lower processing limits and circumstances, including those within standard operating procedures, that pose the greatest chance of process or product failure (when compared to ideal conditions). Such conditions do not necessarily induce product or process failure.
Source: GMP Draft Annex 1
The Importance of Cleanroom Validation
Cleanroom validation offers ISO compliance and peace of mind.Read more
How Big is a Micron?
How often do we actually think about how small a micron actually is?Read more
7 Steps to a Cleaner Environment
The risk to a finished products sterility increases, as operator activities increase within an asept...Read more