Procedures reviewed against PIC/S PE 009-17
Ergopharm has completed a review of its GMP procedures against PIC/S PE 009-17, the current revision of the PIC/S Guide to Good Manufacturing Practice.
The PIC/S guide tracks EU GMP closely, and the review was principally a confirmation exercise: comparing each chapter and annex against the corresponding site procedure and recording either conformity or an action. The value of doing it formally is that it produces a documented map rather than a general confidence.
“A documented map beats a general feeling that we are probably compliant.”
The review paid particular attention to the annexes that bear on the site's operations — sterile manufacture, computerised systems, qualification and validation, and certification by the authorised person — and to the data-integrity guidance in PIC/S PI 041-1.
Gaps identified were raised through change control with owners and dates, and closed under the normal quality system rather than as a special project.
Key facts
- Reference
- PIC/S PE 009-17
- Method
- Chapter-by-chapter comparison against site procedures
- Focus
- Sterile, computerised systems, qualification, certification
- Data integrity
- PIC/S PI 041-1
This notice describes Ergopharm’s own packaging and processes and how they follow published standards; it does not assert a specific national marketing approval.