how do you perform the investigation for an microbiological OOS?
I'm working in non sterile product company and we are revisioning our SOP in according MHRA guidance.
After retest on initial samples (if available) our doubts are on number of resamples. 3,6? Statistical decision?
And when the initial samples are not available (exmple enviromental samples) do you perform a new analysis with new sample?
Any suggestion will be appreciated!
Thanks in advance and have a great day everyone,
The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) and supported by
our sponsors as a service to the scientific community.
Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
If your company would be interested in sponsoring this community, please contact [log in to unmask]
Science Advisory Board https://www.scienceboard.net/
Steris - http://www.sterislifesciences.com/
Charles River Laboratories - http://www.criver.com/
Veltek Associates, Inc - http://www.sterile.com
Microbiologics, Inc. - http://www.microbiologics.com
BD Industrial Media - http://www.bd.com/ds/
Boston Analytical http://www.bostonanalytical.com/
Associates of Cape Cod, Inc. - http://www.acciusa.com/
The nature of this service is to provide a medium for communication. The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PMF, or the sponsors of the list.