While it is not specifically mentioned in the Q7A document, some companies have chosen to
control their documents in this manner. The white box that was shown on the slide said that
there’s no one right way to do it. You can have all of the instructions on one document, and then
you can have a short document that would have the same numbers, so you just record the
results. That’s what is meant by short, as opposed to having blanks throughout the instruction
where you would record the results, and each completed batch record would be a copy of the
instruction and the results together
A similar situation occurs in drug products regarding the requirements of where it
says, “documentation that each significant step in the manufacturing, processing, packing, or
holding of the batch was accomplished.” A good example would be documenting an integrity test
on a .22-micron filter. In some companies, in the batch record, it will say perform the integrity test
following procedure so-and-so, and the person then goes and looks up the procedure. Other
companies will detail the actual procedure in the batch records.
