Testing of incoming materials
Article 31
1. At least one test shall be performed to verify the identity of each batch of incoming material. A supplier's certificate of analysis may be used in place of performing tests, provided that the manufacturer has a system in place to evaluate suppliers. 2. Supplier approval shall include an evaluation that provides adequate evidence (e.g. compliance history), that the manufacturer consistently provides material meeting the relevant specifications. 3. A full analysis shall be conducted on at least three batches of incoming material before reducing in-house testing of that material. That full analysis shall be performed at appropriate intervals and compared with the supplier’s certificates of analysis. 4. The reliability of certificates of analysis shall be checked at regular intervals. 5. By way of derogation from paragraph 1, processing aids, hazardous or highly toxic raw materials, other special materials, or materials transferred to another unit within the manufacturer’s control do not need to be tested if the supplier’s certificate of analysis is obtained, showing that those materials conform to established specifications. Visual examination of containers, labels, and recording of batch numbers shall contribute to establish the identity of those materials. The lack of on-site testing for those materials shall be justified and documented.