Records for raw materials, intermediates, active substance labelling and packaging materials
Article 24
1. Adequate records shall be kept to enable the entire history of a batch to be traced. 2. Receipt and batch processing records shall be kept for each delivery of materials used in the manufacturing, including raw materials, intermediate as well as labelling and packaging materials. Those records shall include: (a) the name of the manufacturer of the delivered material; (b) identity and quantity of each delivery of each batch of raw materials, intermediates or labelling and packaging materials for active substances; (c) the name of the supplier; (d) the supplier’s identification number; (e) the identification number allocated upon receipt and the date of receipt; (f) the results of any test or examination performed and the conclusions thereon; (g) records tracing the use of materials; (h) documentation of the examination and review of active substance labelling and packaging materials for conformity with established specifications; (i) the final decision regarding rejected raw materials, intermediates or active substance labelling and packaging materials. 3. Master labels shall be maintained for comparison to issued labels.