Document control system established
Ergopharm has established its document control system, defining a single controlled hierarchy for how procedures are written, reviewed, approved, issued, revised and withdrawn.
Uncontrolled documents are the quiet source of most GMP failures. Two versions of a procedure in circulation means two ways of doing the job, and the batch record will not say which was followed. Control means that only one version is current, that it is unambiguous where to find it, and that superseded copies are physically removed rather than trusted to go unused.
“Two current versions of one procedure is not a documentation problem. It is two different products.”
The hierarchy runs from the quality manual through policies, standard operating procedures, work instructions and forms, with each level authorised at the level appropriate to its scope. Every document carries an identifier, a version, effective and review dates, and the signatures of the author, reviewer and approver.
Issued copies are stamped and reconciled on withdrawal, and the retention periods for executed records follow the product's shelf life plus the margin the quality system defines.
Key facts
- Hierarchy
- Quality manual → policies → SOPs → work instructions → forms
- Each document
- Identifier, version, effective and review dates, signatures
- Control
- Issued copies stamped; superseded copies withdrawn and reconciled
- Retention
- Shelf life plus the defined margin
This notice describes Ergopharm’s own packaging and processes and how they follow published standards; it does not assert a specific national marketing approval.