Reply
Tue 19 Apr, 2011 11:30 pm
batch = ?
Context:
1. Failure of your quality unit to ensure that materials are appropriately tested and the results are reported.
For example, your Quality Control Unit (QCU) approved the release of four (b)(4) USP batches (#(b)(4)) without data to support that the test for organic volatile impurities (OVI) met release specifications.
While your Certificates of Analysis state that OVI levels conformed to specifications, the inspection found that no testing was done.
It is essential that your firm only report results to customers when you have actually performed the analysis.
batches = a production run.
A certain amount of product is produced and given a batch number. It may be that the machinery is cleaned and/or reset after this amount has been produced.
It may be that a new batch numbers coinicede with beginning to use a new shipment of input raw material.
Any production after this (cleaning/resetting/materials) is given a different batch number, production is continued until a predetermined amount of production is reached or another shipment of raw materials is being used.
Why use batch numbers?
In the case of food production a sample is taken of each batch. If it is contaminated in some way production can be halted and the contamination source can be identified and removed by cleaning machnery or removing contaminated raw materials.
Because we have clear sample tests prior to this batch we do not have to withdraw and destroy all our production, only the production related to the particular batch needs to be recalled from the market place.
@oristarA,
It is not possible to determine what USP means from the context you hav provided. A guess relating to your usual field of queries (health medicine and science) leads me to guess that USP may mean The United States Pharmacopeia (USP).
The United States Pharmacopeia (USP) is a non–governmental, official public standards–setting authority for prescription and over–the–counter medicines and other healthcare products manufactured or sold in the United States.
Stumble It!
Tweet This
Bookmark on Delicious
Share on Facebook
Share on MySpace