The document discusses GMP guidelines for the rejection, reprocessing, reworking, recovery of materials and solvents, and returns of intermediates and APIs. It provides definitions and guidelines for each topic. Specifically, it states that rejected materials can be reprocessed or reworked if properly evaluated and tested to ensure equivalent quality. Recovered materials and solvents may also be reused if approved procedures are followed to ensure they meet standards. Returns must be identified, evaluated, and either reprocessed, reworked or destroyed depending on their condition.

1. GMP
REJECTION AND RE-USE OF MATERIALS
Name : Miss. Pranali Polshettiwar
M. Pharm. 1st yr
Sinhgad Institute of Pharmacy, Narhe
Pune- 41

2. Content :
 Rejection
 Reprocessing
 Reworking
 Recovery of materials and solvents
 Returns

3. Rejection
 Intermediates and APIs which does not meet established
specifications and standards should be identified as such
and quarantined.
 These intermediates or APIs can be reprocessed or
reworked.
 The final disposition of rejected materials should be
recorded.

4. Reprocessing
 Rejected intermediate or APIs are introduced back into the process and
reprocessed by appropriate chemical or physical manipulation steps (ex.,
crystallization, distillation, filtration, chromatography, milling etc.) that are
part of the established manufacturing process.
 If such reprocessing is used for a majority of batches, it should be included
as a part of standard manufacturing process.
 If an in-process control test shows any step incomplete and that incomplete
process is continued, it is considered to be part of the normal process and
not reprocessing.
 Introducing unreacted material back into a process and repeating a chemical
reaction is considered to be reprocessing unless it is part of established
process.
 Such reprocessing should be preceded by careful evaluation to ensure that
the quality of the intermediate or API is not adversely affected due to the
potential formation of by-products and over-reacted materials.

5. Reworking
 Before introducing rejected intermediates or APIs batches for reworking, an
investigation should be performed to find out the reason behind rejection of
batches.
 Batches that have been reworked should be subjected to appropriate
evaluation, testing, stability testing and documentation to show that the
reworked product is of equivalent quality to that produced by original
process.
 For rework process, Concurrent validation is appropriate as this allows a
protocol to define the rework procedure, how it will be carried out, and the
expected results.
 Procedures should provide for comparing the impurity profile of each
reworked batch against batches manufactured by the established process.
Where routine analytical methods are not sufficient to characterize the
reworked batch, additional methods should be used.

6. Recovery of materials and solvents
 Recovery (ex., from mother liquor or filtrates) of reactants, intermediates, or
the API is considered acceptable if approved procedures exist for the
recovery and the recovered materials meets established standards and
specifications.
 Solvents can be recovered and reused in the same processes or in different
processes, if the recovery procedures are controlled and monitored to ensure
that solvents meet appropriate standards before reuse or mix with other
approved materials.
 Fresh and recovered solvents and reagents can be combined if adequate
testing has shown their suitability for all manufacturing processes in which
they may be used.
 The use of recovered solvents, mother liquors, and other recovered
materials should be adequately documented.

7. Returns
 Returned intermediates or APIs should be indentified as such and
quarantined.
 If the conditions under which returned intermediates or APIs have been
stored or shipped before or during their return or the condition of their
containers cause doubts on their quality, the returned intermediates or APIs
should be reprocessed, reworked or destroyed, as appropriate.
 Records of returned intermediates or APIs should be maintained. For each
return, documentation should include the following:
1. Name and address of the consignee
2. Intermediate or API, batch number and quantity returned
3. Reason for return
4. Use or disposal of the returned intermediate or API