Pharmaceutics International, Inc. (Pii), a leading contract development and manufacturing organization, announced it has successfully completed the first ever US-based joint European Medicines Agency (EMA) and Food and Drug Administration (FDA) inspection.
"Our entire team is very proud of the successful outcome of the joint FDA/EMA inspection,” said Tony Horton, vice president of quality assurance at Pii. “This achievement validates our commitment to continuous improvement and our ability to continue to meet the requirements of the FDA, EMA and other international regulatory agencies.”
The rigorous four day inspection was conducted by representatives for the EMA from the Medicines and Healthcare products Regulatory Agency (MHRA) and Medical Products Agency of Sweden (MPA) and from the FDA. The inspection is part of the FDA and EMA joint initiative, which focuses on increasing international regulatory collaboration among the agencies in order to enhance global drug quality and safety.
As part of the inspection, Pii’s clients received EMA marketing authorization for a soft gel product and reauthorization for a tablet product. Additionally, during the audit the FDA performed an inspection of the company’s quality systems as a follow up to its December 2010 inspection for four Pre Approval Inspections. Both FDA inspections have been closed as of June 2011, indicating that Pii is in substantial compliance with US GMPs.
"We are extremely pleased to have achieved this major regulatory milestone," said Steve King, senior vice president of Pii. “This approval allows Pii to continue providing commercial manufacturing services to the global pharmaceutical industry. We look forward to working with our clients to bring several other products to market.”
Pharmaceutics International, Inc. (Pii) is a privately held Drug Delivery Solutions company providing dosage form development and GMP Manufacturing services to the global pharmaceutical industry.