First standard operating procedures issued
Ergopharm has issued the first tranche of controlled standard operating procedures, replacing the working notes of the laboratory years with a numbered, versioned and formally approved document set.
A controlled document is a small thing that changes everything. Once a procedure carries a number, a version and an approval signature, it becomes possible to say what was actually done on a given day — and to prove it. Superseded versions are withdrawn and archived rather than discarded, so a batch made two years ago can still be judged against the instructions that applied at the time.
“The day the documents got version numbers is the day we became a manufacturer rather than a workshop.”
The initial set covered documentation practice itself, training, deviation reporting, equipment calibration, cleaning, and the handling of out-of-specification results. Deliberately, the procedure governing procedures was written first.
Every member of staff working to a procedure is trained against it and the training recorded before the work begins — a rule that has not changed since.
Key facts
- Introduced
- Numbered, versioned, approved SOPs
- First procedure
- Control of documents
- Archive
- Superseded versions withdrawn, retained
- Rule
- Trained and recorded before the task