Earlier today, Pharmaceutics International, Inc. (Pii) announced the successful completion of its first joint inspection by the Food and Drug Administration (FDA) and European Medicines Agency (EMA).
Vice president of quality assurance at Pii, Tony Horton, said: “Our entire team is very proud of the successful outcome of the joint FDA/EMA inspection. 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.”
Representatives from the FDA as well as those from the Medicines and Healthcare products Regulatory Agency (MHRA) and Medical Products Agency of Sweden (MPA) on behalf of the EMA performed a meticulous 4-day inspection. An endeavor to improve global drug safety and quality led to the joint-inspection initiative by the FDA and EMA with special focus on enhancing international regulatory partnership between the agencies.
The clients of Pii obtained EMA marketing approval for a soft gel product and EMA reapproval for a tablet product, as part of the audit. Furthermore, the company’s quality systems were inspected by the FDA, following the December 2010 audit involving four Pre Approval Inspections. As of June 2011, both audits have been cleared indicating that the contract development and manufacturing organization has sufficiently complied with US GMPs.
Senior vice president of Pii, Steve King, said: “We are extremely pleased to have achieved this major regulatory milestone. 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.”