Equipment cleaning, maintenance and use records
Article 23
1. Records of major equipment use, cleaning, sanitisation and sterilisation and maintenance shall be kept. Those records shall include: (a) the date and, if appropriate, the time; (b) product, and batch number of each batch processed in the equipment; (c) the person who performed the cleaning and maintenance. 2. Individual equipment records are not required for equipment dedicated to manufacture of only one active substance or intermediate thereof, provided that batches follow in traceable sequence. 3. Records of major equipment use, cleaning, sanitisation or sterilisation, and maintenance may either be part of the batch record or kept separately.