1. RE PROCESS OF PHARMACEUTICAL BATCH
Compiled by-Shamon Ahmad, M.Pharma (Q.A) Chandigarh Group of Colleges, Landran, Mohali(Punjab
India)email-shmmon@gmail.com on Date-25/12/2012
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(sop se hat k) the original material so that its
quality may be made acceptable.
Reprocessing is taking a material (in-specified or out-of-specified) 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.
The ICH Q7A guidline definitions are given below:
REPROCESSING:
Introducing an intermediate or API, including one that does not conform to standards or
specifications, back into the process and repeating a crystallization step or other appropriate
chemical or physical manipulation steps (e.g., distillation, filtration, chromatography,
milling) that are part of the established manufacturing process.but it new Process batch give
New Batch;No differ to previes....
NOTE: Continuation of a process step after an in-process control test has shown that the step
is incomplete, is considered to be part of the normal process, and is not reprocessing. (ICH
Q7A, August 2001)
Reworking:
Subjecting an intermediate or API that does not conform to standards or specifications to one
or more processing steps that are different from the established manufacturing process to
obtain acceptable quality intermediate or API (e.g., recrystallizing with a different solvent).

2. (ICH Q7A, August 2001)
The guideline is written for Active Pharmaceutical Ingredients (APIs).
Recovery
Any treatment of materials by a process intended to make them suitable for further use.
Reprocessing
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 6: 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:
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.