Regulatory Requirements for Reprocess and Re-work


Process repeating a crystallization step or other appropriate chemical or physical manipulation steps (e.g., distillation,filtration, chromatography, milling).


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).

1. Section 211.115 of 21 CFR of USFDA

21 CFR Sec. 211.115 Reprocessing.

a) Written procedures shall be established and followed prescribing a system for reprocessing batches that do not conform to standards or specifications and the steps to be taken to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics

(b) Reprocessing shall not be performed without the review and approval of the quality control unit.

2. Schedule M of Drugs Rules 1945

14. Rejection and reuse of materials

14.2. Reprocessing

Section 14.2.3.

Introducing unreacted material back into a process and repeating a chemical reaction is considered to be reprocessing unless it is part of the established process. Such reprocessing shall 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 overreacted materials.

14.3. Reworking

Section 14.3.3.

Procedures shall provide for comparing the impurity profile of each reworked batch with batches manufactured by the established process. Where routine analytical methods are inadequate to characterise the reworked batch, additional methods shall be used.

3. Guidance for Industry, Q7A GMP Guidance for API

B. Reprocessing (14.2)

C. Reworking (14.3)

4. WHO TRS no. 986, Annexure 2

Rejected, recovered, reprocessed and reworked materials

Section: 14.31.

5. EU Guidelines Volume 4, Part I, Chapter 5, Production

Rejected, recovered and returned materials 

Section: 5.67

Section: 5.69

6. EudraLex GMP Volume 4

14.2 Reprocessing Section 14.22 

14.3 Reworking Section 14.32 

7. ICHQ7

14.2 Reprocessing Section 14.22

14.3 Reworking Section 14.31


8. PIC/S PE 009-17 (Part II)


14.2 Reprocessing Section 14.22 

14.3 Reworking Section 14.32 

All above regulatory guidelines are having similar clauses for re-process and re-work.

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Resource Person: Dr. Prasadhi Shiva

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