Rejection
Article 60
Active substances and intermediates thereof failing to meet established specifications shall be identified as such and quarantined. The final disposal of rejected materials shall be recorded.
Commission Implementing Regulation (EU) 2025/2154 CHAPTER XIV — REJECTION AND RE-USE OF MATERIALS
Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Reprocessing
Article 61
1. An intermediate or an active substance, including one that does not comply with standards or specifications, may be introduced back into the manufacturing process and reprocessing by repeating a crystallisation step or other appropriate chemical or physical manipulation steps (e.g. distillation, filtration, chromatography, milling) that are part of the established manufacturing process. Whenever such reprocessing is used for the majority of batches, that reprocessing shall be included as part of the standard manufacturing process. 2. 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 active substance or intermediates thereof is not adversely impacted due to the potential formation of by-products and over-reacted materials.
Reworking
Article 62
1. Batches that do not conform to established standards or specifications shall not be reworked unless an investigation into the reason for non-conformity has been performed. 2. Batches that have been reworked shall be subject to appropriate evaluation, testing, stability testing if warranted, and documentation to show that the reworked product is of equivalent quality to that produced by the original process. 3. Concurrent validation may be used as a validation approach for rework procedures. In case only one batch shall be reworked, a report may be written, and the batch may be released once it is proved to be acceptable. 4. Procedures shall provide for comparing the impurity profile of each reworked batch against batches manufactured by the established process. Where routine analytical methods are inadequate to characterise the reworked batch, additional methods shall be used.
Recovery of materials and solvents
Article 63
1. Reactants, intermediates or the active substance may be recovered (e.g. from mother liquor or filtrates), provided that approved procedures exist for the recovery and the recovered materials meet the required specifications. 2. Solvents may be recovered and re-used in the same processes or in different processes, provided that the recovery procedures are controlled and monitored to ensure that solvents meet established standards before re-use or co-mingling with other approved materials. 3. Fresh and recovered solvents and reagents may be combined provided that adequate testing has shown their suitability for the intended use. 4. The use of recovered solvents, mother liquors and other recovered materials shall be adequately documented.
Returns
Article 64
1. Returned intermediates or active substances shall be clearly labelled as such and quarantined. 2. If the conditions under which returned intermediates or active substances have been stored or shipped before or during their return or the condition of their containers casts doubt on their quality, the returned intermediates or active substances shall be reprocessed, reworked or destroyed, as appropriate. 3. Records of returned intermediates or active substances shall be maintained in accordance with the provisions of Article 21(4) of Commission Implementing Regulation (EU) 2021/1280 ( 7 ) .
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