Should an Equipment Use Log be maintained for non-dedicated equipment? Should it include listing which piece of equipment was used for that particular product at that particular moment?

Section 6.2 of Q7A clearly states, “If equipment is dedicated to manufacturing one intermediate or
API, individual equipment records are not necessary if batches of the intermediate or API follow in
traceable sequence. In cases where dedicated equipment is employed, the records of cleaning,
maintenance, and use can be part of the batch record or maintained separately”. Thus, it is up to
each company to define the format for maintaining these records.