What a pharma batch record needs from the inspection system
Look first at which items the agreement asks for. The master version and the exception rolls must be exportable. Without an agreement, do not call the record compliant.
What a pharma batch record needs from the inspection system is the master version used for this batch, whether inspection stayed on for the whole run, how the exception rolls were handled, and who released them. Which pages are required follows the quality agreement. Without an agreement, do not claim that the record meets a pharma requirement.
Why it is judged this way
A mass of images in the system is not a batch record. The batch record wants the few lines that fit in the batch file: whether it was on, whether it was switched off in the middle, and where the failed rolls are. Make those lines one sheet per batch. Store the images separately by roll number.
What to compare
| What you see | What to call it | What not to do |
|---|---|---|
| Every item the agreement names is there | It can go into the batch record | Treat a dump of every original image as enough |
| There was a bypass in the middle | Write it in the exceptions | Hide it |
| There is no quality agreement | Ask what is wanted first | Use another industry’s form |
At job change or when a roll is opened
- Open the clause in the agreement that is about inspection.
- Make one page per batch.
- Write the handling of each exception roll.
