08.19.11
Pharmaceutics International, Inc. (Pii) has successfully completed its first US-based inspections by the European Medicines Agency (EMA) and FDA. The four-day inspection was conducted by the agencies as part of a joint initiative focused on increasing international regulatory collaboration among the agencies to enhance global drug quality and safety.
"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."
As part of the inspection, Pii's clients received EMA marketing authorization for a softgel product and reauthorization for a tablet product. The FDA performed an inspection of the company's quality systems as a followup to its December 2010 inspection for four Pre Approval Inspections. Both FDA inspections have been closed indicating that Pii is in compliance with 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."
"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."
As part of the inspection, Pii's clients received EMA marketing authorization for a softgel product and reauthorization for a tablet product. The FDA performed an inspection of the company's quality systems as a followup to its December 2010 inspection for four Pre Approval Inspections. Both FDA inspections have been closed indicating that Pii is in compliance with 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."
