Tuesday, September 6, 2016

Difference between Rework and Reprocess



Rework and reprocess are very confusing terms. There has always been an uncertainty which procedure is to be followed. Below is an effort to define both in simple terminology


To understand rework and reprocess the first thing is to make it clear that the material which is supposed to be reworked or reprocessed are always the non-conforming products. It means while assessing the disposition of the nonconforming products it will be analysed whether the product shall be reworked or reprocessed.

Rework and reprocess are both not routinely done.

Rework will be done when the material or drug is not having the desired standards, as a result an extra work is done to bring it back to the set standard. This effort of extra work is different from the established validated manufacturing procedure. This is not always necessary that rework is applicable to each and every industry. Nevertheless every industry must have the procedure for rework and at least the middle management and higher are aware of the concept of "Rework".

On the other hand "reprocess is the repetition of the same predefined process."

Therefore, in order to decide whether the SOP of rework or reprocess is to be followed, the first thing which shall come to mind is that the product is a non conforming product. This shall be brought to the notice of higher management. The NCR committee shall decide the disposition of the material.

During decision of the disposition the committee may decide that the material may again follow the same validated procedure or a procedure which is different from the established procedure.

If the same validated procedure is followed than the material is considered to be reprocessed on the other hand if different procedure is followed than the material is said to be reworked.

AUTHOR: ANSHU YADAV
anshuyadav.icgian@gmail.com
quallpharmaconsultancy@gmail.com