This FAQ paper is a follow up to the webinar, “Understanding 21 CFR Part 11 and Data Integrity Regulations”. Many thoughtful questions were asked about the specific guidelines of 21 CFR Part 11 relating to data integrity, and how they impact operations. Read questions and answers submitted during and after the webinar and also submit questions of your own.
Filling Line Contamination can be generally avoided through an effective contamination monitoring system, starting with a risk assessment.
A theoretical case study involving the steps of classification, risk assessment and monitoring plan verification was conducted. The classification used total particle concentration and environmental monitoring data and established routine microbiological and particle monitoring points for an aseptic filling line. The cleanroom utilized Grade A, B, C and D zones.
