Rework and reprocess are very confusing terms. There has always been an uncertainty about 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 is always the non-conforming product.
It means while assessing the disposition of the nonconforming products it will be analyzed whether the product shall be reworked or reprocessed.
What is the rework process?
Rework is defined as a product that has been recovered or rejected from normal production and has been reprocessed, re-blended, or reformatted into the finished product. Mishandling of rework may result in potential withdrawal/recall of products, which could affect the loss of customers and consequently loss of profit.
Rework and reprocessing are both not routinely done.
Rework will be done when the material or drug is not having the desired standards, as a result, 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 a procedure for rework and at least the middle management and higher are aware of the concept of "Rework".
What is reprocessing in the pharmaceutical industry?
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.
On the other hand "reprocess is the repetition of the same predefined process."
Therefore, in order to decide whether the SOP of rework or reprocessing 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 the decision of the disposition, the committee may decide that the material may again follow the same validated procedure or a procedure that is different from the established procedure.
If the same validated procedure is followed then the material is considered to be reprocessed on the other hand if a different procedure is followed then the material is said to be reworked.
ALSO READ: SOP for Rework/Reprocessing Procedure
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Quality Control
