Structured GMP training programme introduced
A structured training programme has replaced ad-hoc instruction at the Vadodara site, with induction, role-specific and annual refresher modules, and effectiveness assessed rather than assumed.
Attendance is not competence. Each module now ends with an assessment appropriate to the task — a written check for documentation practice, an observed demonstration for gowning and aseptic technique. Where an assessment is not passed, the training is repeated before the person works unsupervised.
“We stopped asking who attended and started asking who can do it.”
Training records are held against the individual and against the procedure, so it is possible to ask both 'what is this operator trained on?' and 'who is trained on this revision?' — the second question being the one that matters when a procedure changes.
Aseptic operators additionally requalify through participation in media fills, linking training directly to the assurance of sterility rather than to a classroom.
Key facts
- Structure
- Induction · role-specific · annual refresher
- Assessment
- Written or observed, appropriate to the task
- Records
- Held against both person and procedure revision
- Aseptic staff
- Requalified through media-fill participation