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.