Preparing the published article.
Case: Pharmaceutical Blister Packing
Validation paperwork can exceed the engineering effort.
Case outline
| Item | Detail |
|---|---|
| Process | Blister packing and cartoning with inspection |
| Problem | Repetitive manual handling and audit requirements |
| Approach | Robots with vision inspection and documented change control |
| Outcome | Consistent output with traceable batch records |
Implementation notes
- Qualification documentation (IQ/OQ/PQ) is part of the project scope.
- Cleaning and changeover procedures must be validated, not just written.
- Any change to the program requires change control.
Pharmaceutical requirements are regulated and site-specific. Confirm the applicable rules with the quality function.