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.