The May 2011 audit is the fourth since 2003 during which these laboratory operations have not been issued an FDA-483 citing any inspection concerns. The FDA conducted its audit this year in the Durham lab's new location at 4620 Creekstone Drive, which AAIPharma Services moved into in 2010.
"Once again passing the FDA inspection without issue reflects the strong focus on compliance and accurate documentation that is the legacy of AAIPharma Services," said Christopher Smith, vice president of Corporate Quality Assurance and Regulatory Affairs. "Having this laboratory testing facility thoroughly audited is a reassurance to our global clients that their pharmaceutical products developed and tested here for clinical and commercial uses will be of the highest quality and meet regulatory standards."
Smith also noted that the successful FDA audit in Durham comes on the heels of two Good Manufacturing Practices (GMP) certificates issued by the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) to AAIPharma Services Corp. The European Union (EU) GMP Certificates followed audits of the company's Charleston, S.C., manufacturing and lab operations for parenteral products and its Wilmington, N.C., inspection, labeling, packaging, shipping and lab operations supporting Charleston.
Chief Executive Officer Pat Walsh said, "Earning these EU GMP Certificates lets our global clients know they will have no issues shipping pharmaceuticals from these facilities into Europe, or into countries such as Canada and Australia that have mutual recognition agreements (MRAs) with the EU. It gives our clients confidence in AAIPharma Services as their preferred provider of drug product development and manufacturing, from compound to clinic around the world."
"Once again passing the FDA inspection without issue reflects the strong focus on compliance and accurate documentation that is the legacy of AAIPharma Services," said Christopher Smith, vice president of Corporate Quality Assurance and Regulatory Affairs. "Having this laboratory testing facility thoroughly audited is a reassurance to our global clients that their pharmaceutical products developed and tested here for clinical and commercial uses will be of the highest quality and meet regulatory standards."
Smith also noted that the successful FDA audit in Durham comes on the heels of two Good Manufacturing Practices (GMP) certificates issued by the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) to AAIPharma Services Corp. The European Union (EU) GMP Certificates followed audits of the company's Charleston, S.C., manufacturing and lab operations for parenteral products and its Wilmington, N.C., inspection, labeling, packaging, shipping and lab operations supporting Charleston.
Chief Executive Officer Pat Walsh said, "Earning these EU GMP Certificates lets our global clients know they will have no issues shipping pharmaceuticals from these facilities into Europe, or into countries such as Canada and Australia that have mutual recognition agreements (MRAs) with the EU. It gives our clients confidence in AAIPharma Services as their preferred provider of drug product development and manufacturing, from compound to clinic around the world."
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