Question on Yield and OEE in Phama Production Lots

• QUES:  I read in some FDA document about yield. I have seen some warning letters exactly on this topic as well. However, there are many instances where OEE is prepared instead of yield. And classified as Non GMP. Are these 2 different things ? And should OEE be classified as Non-GMP ?

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  ANS:  OEE = Overall Equipment Effectiveness (OEE).  OEE is a measure of how effectively a manufacturing operation is being utilized.  I can't give you an FDA "approved" answer as I have no information / experience from them on that subject.  My personal opinion currently is that I would not recommend substituting one for the other.  Yield is a specific lab calculation(s) required under the CGMPs for various processes in / during and at the end of a lot and logged as part of the batch record. OEE is more a manufacturing process utilization measurement, usually more generalized, which could be part of the CGMPs P&PC "tools" but is not specifically mandated in the CGMPs.  And you have to meet the CGMPs. If you could show a 100% correlation between the two at the level of the requirements of yield and its intervals required in the process for each lot, and the OEE data is handled under the rigors / documentation of the CGMPs, you may have a rationale for such use, but that's highly ify and I can't comment on that vis-a-vis your operation.  

• -- jel@jelincoln.com