Section 6.2 states that “records of major equipment use, cleaning, sanitation, and/or sterilization
and maintenance, should show the day, time (if appropriate), product, batch number of each
batch processed in the equipment and the person who performed the cleaning and maintenance.
If equipment is dedicated to manufacturing one intermediate or API, then individual equipment
records are not necessary. In cases where dedicated equipment is employed, the records of
cleaning, maintenance, and use can be part of the batch record or maintained separately.”
It certainly seems to imply that if it is not dedicated, then you don’t have those two options. You
only have the option of having it as part of the batch record.
This is one area where the EWG was attempting to address the uniqueness of API
manufacturing. In many API plants, the entire operation is often controlled from an operation or a
control room, where you have an electronic board or some type of automatic control system and
the operators sit there and push buttons to control the process. Imagine if, before a particular
piece or reactor was to be used, the operator had to stop the process run down to the second
floor to get the equipment use and cleaning log for that particular reactor. This doesn’t sound
reasonable. From the GMP perspective, it’s important that equipment cleaning and use be
documented. Where it is documented is up to the company.
