- Piramal Pharma Solutions’ Grangemouth facility has received updated MHRA GMP certificates following a successful compliance review and desktop inspection.
- The certification covers activities in the Helix building, including clinical and commercial drug substance manufacture, testing, warehouse operations and laboratory areas.
Piramal Pharma Solutions has announced that its Grangemouth, UK facility has received updated MHRA GMP certificates following a successful compliance report and desktop inspection. The updated certification applies to all activities within the site’s Helix building, which specialises in clinical and commercial drug substance manufacture and testing.
According to the announcement, the certificates also extend to the building’s supporting warehouse and laboratory areas. Together with existing GMP approvals, the updated status ensures the facility can continue supporting client programmes and regulatory submissions. The Grangemouth site is the company’s dedicated location for antibody-drug conjugate development and manufacturing, providing services from process development through to scale-up.
The facility also plays a role in the ADCelerate programme, designed to streamline the route from R&D to GMP production. Piramal said the updated certifications reflect the site’s strong regulatory track record, which includes successful inspections by authorities such as the USFDA, PMDA, ANVISA, the Turkish Ministry of Health and the South Korean FDA.
“This achievement underscores the Grangemouth facility’s dedication to upholding the highest standards of quality across their operations.”
Peter DeYoung, CEO of Piramal Global Pharma
