Monday, 9 March 2015

Auditing Cleanrooms

Quality auditing is the systematic examination of a quality system and audits form an important part of Good Manufacturing Practice (GMP). Auditors need to be knowledgeable about cleanroom operations, and have an understanding of microbial contamination as well as being trained specifically as auditors. Ideally, the auditors should have complete independence of the functions they are auditing.

This is the basis of an article by Tim Sandle for Cleanroom Technology. The reference is:

Sandle, T. (2015) Auditing Cleanrooms, Cleanroom Technology, February 2015, pp66-68

For a copy of the article, please contact Tim Sandle

Many aspects of a cleanroom are designed to ensure contamination control, including the control of air movement, air filtration, cleanroom practices, cleaning and disinfection schemes. Tim Sandle discusses how the different aspects are checked and assessed through the audit process.

Posted by Tim Sandle