Batch production and control records
Article 26
1. Batch production records shall be prepared for each active substance and intermediate thereof. Those batch production records shall: (a) for each batch include the complete information referred to in paragraph 2; (b) be checked before issuance of the record to assure that it is the correct version and a legible accurate reproduction of the appropriate master production instruction; (c) include a reference to the master production instructions being used, in case that batch production record is produced from a separate part of the master production instruction; (d) be numbered with a unique batch or identification number and dated and signed when issued. In continuous production, the product code together with the date and time may serve as the unique identifier until the final number is allocated. 2. Batch production and control records shall include: (a) dates and, where appropriate, times of production and control; (b) identification of major equipment (e.g. reactors, dryers, mills, etc.) used; (c) specific identification of each batch, including weights, measures, and batch numbers of raw materials, intermediates, or any reprocessed materials used during manufacturing; (d) results recorded for critical process parameters; (e) samplings performed; (f) signatures of the persons performing and directly supervising or checking each critical step in the operation; (g) in-process and laboratory test results; (h) yield at appropriate phases or times; (i) description of packaging and labelling of the active substance or the intermediate thereof; (j) the representative label of active substance or intermediate thereof, if made commercially available; (k) any deviation from procedures and instructions or any unusual occurrence which could impact the manufacture or testing of the active substance, its evaluation, investigation conducted (if appropriate) or reference to that investigation if stored separately; (l) results of the release testing. 3. Written procedures shall be established and followed for investigating critical deviations from procedures and instructions or any unusual occurrence which could impact the manufacture or testing of the active substance or the failure of a batch of active substance or intermediate thereof to meet specifications. The investigation shall be extended to other batches that may have been associated with that deviation or failure.