Penn
FDA Completes Successful Audit of Penn Pharma’s Facility in South Wales - 24 May 2010
Penn Pharma is pleased to announce the successful outcome of a recent FDA GMP inspection of its facility in South Wales, UK. The 5-day inspection occurred from May 10 - 14 and produced NO 483s. The audit inspection focused on several of Penn’s key service
areas, such as manufacturing, analytical services, packaging/labelling and logistics.
Mr. Mark Molyneux, CEO & Chairman of Penn Pharma said, "We are very pleased with the results of the recent FDA audit. It demonstrates our commitment to provide world-class services through quality systems and personnel."
Penn Pharma is a leading provider of fully integrated and cost effective pharmaceutical development and custom manufacturing services to the international healthcare industry, whose services support a fast and effective route from clinic to market. Penn provides unparalleled service offerings developed over its 30 year trading history.
From its fully integrated Headquarters in South Wales, UK, Penn’s core services include:
- Formulation development
- Analytical development & stability studies
- Clinical Trial Supply - packing and labelling
- Storage & Distribution - including the storage, distribution, returns, destruction and inventory management of clinical trial material
- Clinical Trial Manufacturing including highly potent molecules Specialised custom manufacturing, from pilot to commercial batch sizes
- Manufacture of Specials (unlicensed medicines)
- CMC Consultancy
- Qualified Person (QP) Release services
- Commercial Product Sourcing for Clinical Trials
Our facility meets the highest quality and regulatory standards, is licensed by the MHRA and is inspected by the FDA. Penn is also licensed by the UK Home Office for importation and storage of controlled drugs.
Recent Press
- ONE YEAR ACCIDENT FREE!
- 11 Jan 2012
- Penn is delighted to announce that it has achieved a full 365 recordable accident free days.
