Data Integrity: Understand and Comply with GMP and FDA Requirements for 21 CFR Part 11
Learn about 21 CFR Part 11 and data integrity requirements including general provisions, electronic signatures, data management, and more.
Knowledge Category: Regulatory
Regulatory Compliance with Pharmaceutical Viable Air Monitoring in ISO 5 (Grade A)
Viable air monitoring is a crucial part of an environmental monitoring program in pharmaceutical manufacturing. The absence of microbial contamination is considered a critical quality attribute due to its potential to dramatically impact, directly or indirectly, the safety and/or the efficacy of the drug product. It has been many years since common viable air monitoring methodologies have been introduced and become standard. It is well documented that traditional methods are insensitive. Singular results only provide an indicator of cleanroom status, and very often no direct correlation between number of organisms and product contamination risks are found.
21 CFR Part 11 and Data Integrity Regulations Frequently Asked Questions
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.
Analysis of an Aseptic Process and Defining a Cleaning and Sanitization Plan