Hello,
My question is in regards to FDA regulated manufacturing facilities. What is meant by "re-work" and "re-process"? Our facility is not a medical devices facility. It is Pharmaceutical.

Split from and Moved from the 'Introductions' thread to the FDA forum as a stand-alone thread.

Found a nice description here (http://www.fda.com/forum/showtopic.php?tid/3400/):

Reprocessing is taking a material (in-spec or out-of-spec) and reintroducing it to an existing (validated) process.

Reworking is taking an out-of-spec product and running it through a non-standard process to bring it back into spec. Concurrent validation is required.

Scott is right on the definitions.

Just to cite an official definition from the CEFIC.pdf (http://apic.cefic.org/pub/1GMP-API9604.pdf)

Reprocessing is the treatment of a batch or sub-batch of materials of unacceptable quality by repeating the same process steps from a defined stage of production so that its quality may be made acceptable.
NOTE: The occasional repeating of one or more process steps during manufacture after it was known that the pre-set limits had not been met, or there was an unexpected process problem, is an acceptable part of the process and a rational reaction to the results obtained.

Reworking is the treatment of a batch or sub-batch of materials of unacceptable quality by using a process other than that used to produce the original material so that its quality may be made acceptable.

Additional information on these 2 terms are provided in Section 18 of the document that I referenced earlier.

Also see: Rework (http://elsmar.com/Forums/showthread.php?t=12639).

Not much has been posted on Reprocessing before now. Good information.