AAIPharma Services Builds Compliance Record at Lab, Manufacturing and Packaging Operations

WILMINGTON, N.C., June 30, 2011 /PRNewswire/ — AAIPharma
Services Corp., a leading provider of pharmaceutical product
development and manufacturing services, announced that it has
passed inspection of its Durham analytical lab by the Food and Drug
Administration (FDA) with no inspectional observations. 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 a

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