what are peoples thoughts on when you can or can not perform a re-test following obtaining an Atypical or OOS result for a finished product?
Would you say that a re-analysis/re-test (from the same starting sample(s) e.g bottles/sampled material in a container) is for additional information only to support a decision or if the result is then within specification it can be used as a final result and initial result was incorrect (i think that that is not the expeceted, as you are not clearly justifying not using teh original result).
I have previously heard that it is reasonable to assume that the filled product with any contamination may not be homogenous and therefore you may not be able to obtain repetitive results and confirm one way or another?
however if we do say that contamination within the batch is not homogenous, how is it reasonably practical to allow us to take such small samples for testing and release on the basis of a satisfactory result if it is understood that some of the batch we dont test could be contaminated and possibly OOS?
Do we need to assume that our products are homogeneous? Any references to guidance documents/presentations would be appreciated.
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.